Postoperative Pain after Treatment Using the GentleWave System: A Randomized Controlled Trial.
Ontology highlight
ABSTRACT: Introduction
Cleaning and shaping are necessary to allow for the delivery of irrigants and medicaments to the apical third of the canal. Standard treatment irrigation generally uses a conventional needle and some frequency of sonic activation. The GentleWave System (GWS; Sonendo, Inc, Laguna Hills, CA) combines irrigant delivery with multisonic activation. This randomized clinical trial aimed to determine if the GWS significantly decreases the incidence and intensity of postoperative pain.Methods
Patients used a numeric rating scale to record their pain level at the 6-hour time point before treatment. All participants were randomly divided into 2 groups and were blind to the treatment they received. The standard (control) group received endodontic treatment with conventional side-vented needle irrigation and ultrasonic activation. The second group received treatment with the GWS. Following treatment, patients used a numeric rating scale to record their pain level at 6, 24, 72, and 168 hours.Results
In the standard treatment group, 72.2% of patients experienced at least 1 occurrence of postoperative pain, whereas in the GWS group, 83.3% of patients experienced at least 1 occurrence of postoperative pain. The highest pain intensity level for both treatments occurred at the 6-hour posttreatment time point. All pain decreased with time after the 6-hour posttreatment time point (P < 1.237e-7).Conclusions
There was no significant difference in the incidence or intensity of postoperative pain after either treatment group. However, both groups reported a statistically significant decrease in pain with time.
SUBMITTER: Grigsby D
PROVIDER: S-EPMC7387160 | biostudies-literature |
REPOSITORIES: biostudies-literature
Similar Datasets
Project description:Introduction: Open-label placebos have been proposed as way of using long recognized analgesic placebo effects in an ethical manner. Recent evidence shows efficacy of open-label placebos for clinical conditions, but there is need for more research on open-label placebos in acute pain. In the treatment of acute postoperative pain, minimization of opioid related side effects remains one of the key challenges. Therefore, this study aims at investigating the potential of adding unconditioned open-label placebos to treatment as usual as a means of reducing opioid consumption and its related side effects in patients with acute postoperative pain. Methods and Analysis: This is the protocol of an ongoing single site randomized controlled trial. The first patient was enrolled in May 2020. In total, 70 patients suffering from acute postoperative pain following dorsal lumbar interbody fusion are randomized to either a treatment as usual group or an experimental intervention group. The treatment as usual group consists of participants receiving a patient-controlled morphine pump. On day 1 and 2 post-surgery, patients in the intervention group receive, in addition to treatment as usual, two open-label placebo injections per day along with an evidence-based treatment rationale explaining the mechanisms of placebos. The primary outcome is measured by means of self-administered morphine during day 1 and 2 post-surgery. Several other outcome measures including pain intensity and adverse events as well as potential predictors of placebo response are assessed. Analysis of covariance will be used to answer the primary research question and additional statistical techniques such as generalized linear mixed models will be applied to model the temporal course of morphine consumption. Discussion: This study will provide valuable insights into the efficacy of open-label placebos in acute pain and will potentially constitute an important step toward the implementation of open-label placebos in the clinical management of acute postoperative pain. In addition, it will shed light on a cost-efficient and patient-centered strategy to reduce opioid consumption and its related side effects, without any loss in pain management efficacy. Ethics and Dissemination: The "Ethikkommission Nordwest- und Zentralschweiz" (BASEC2020-00099) approved the study protocol. Results of the analysis will be submitted for publication in a peer-reviewed journal. Clinical Trial Registration: The study is registered at ClinicalTrials.gov (NCT04339023) and is listed in the Swiss national registry at kofam.ch (SNCTP000003720).
| S-EPMC8602681 | biostudies-literature
Project description:Objective Rectus muscle reapproximation at cesarean delivery (CD) is performed frequently by some obstetricians; however, the effect on postoperative pain is unclear. To this end, we investigated whether rectus muscle reapproximation increases postoperative pain. Materials and Methods This is a prospective, double-blind, randomized controlled trial of women undergoing primary CD with singleton or twin pregnancy at >35 weeks' gestation. Women were randomized to rectus muscle reapproximation with three interrupted sutures or no reapproximation. Exclusion criteria were prior cesarean, prior laparotomy, vertical skin incision, active labor, chronic analgesia use, allergy to opioid or nonsteroidal anti-inflammatory drugs, and body mass index ≥ 40. Intra- and postoperative pain management was standardized within the study protocol. The primary outcome was a combined movement pain and opioid use score averaged over the 72-hour study period, called the Silverman integrated assessment. Movement pain scores were assessed at 24, 48, and 72 postoperative hours. Results In total, 63 women were randomized, of whom 35 underwent rectus muscle reapproximation and 28 did not. Demographic and obstetric variables were similar between groups. Silverman integrated assessment scores during the 72-hour postoperative period were higher in the rectus muscle reapproximation group (15 ± 100% vs. -31 ± 78% difference from the mean; p = 0.04). Operative times were similar between groups (63 ± 15 vs. 65 ± 15 minutes; p = 0.61), and there were no surgical complications in either group. Maternal satisfaction with analgesia at 72 hours was high in both groups (85% [73-90] rectus muscle reapproximation vs. 90% [75-100]; p = 0.16). Conclusion Rectus muscle reapproximation increased immediate postoperative pain without differences in operative time, surgical complications, or maternal satisfaction. Benefits of rectus muscle reapproximation should be weighed against increased postoperative pain, and analgesia should be planned accordingly.
| S-EPMC5565698 | biostudies-literature
Project description:BackgroundProblems with intravenous patient-controlled analgesia (IV PCA) are well known, including invasive route of delivery and pump programming errors. The primary objective of this study was to evaluate patient satisfaction with a novel sublingual sufentanil PCA system (sufentanil sublingual tablet system 15 mcg with a 20-minute lockout interval; SSTS) to IV PCA morphine sulfate 1 mg with a 6-minute lockout interval (IV PCA MS) for the management of acute postoperative pain.MethodsThis was a randomized, open-label, 48-hour non-inferiority study with optional extension to 72 hours at 26 U.S. sites enrolling patients scheduled for elective major open abdominal or orthopedic (hip or knee replacement) surgery. The primary outcome measure was the proportion of patients who responded "good" or "excellent" (collectively "success") at the 48-hour timepoint on the Patient Global Assessment of method of pain control (PGA48).ResultsA total of 357 patients received study drug and 78.5% vs. 65.6% of patients achieved PGA48 "success" for SSTS vs. IV PCA MS, respectively, demonstrating non-inferiority (P < 0.001 using the one-side Z-test against the non-inferiority margin) as well as statistical superiority for treatment effect (P = 0.007). Patients using SSTS reported more rapid onset of analgesia and patient and nurse ease of care and satisfaction scores were higher than IV PCA MS. Adverse events were similar between the 2 groups; however, SSTS had fewer patients experiencing oxygen desaturations below 95% compared to IV PCA MS (P = 0.028).ConclusionsSufentanil sublingual tablet system is a promising new analgesic technology that may address some of the concerns with IV PCA.
| S-EPMC4234007 | biostudies-literature
Project description:BackgroundThis study aimed to assess the influence of continuous rotation and reciprocation kinematics on postoperative pain (POP) levels and substance P (SP) levels in patients diagnosed with irreversible pulpitis and symptomatic apical periodontitis (SAP).Materials and subjectsA total of twenty patients were randomly assigned into two groups: Continuous Rotation Group (CRG) (n = 10), subjected to mechanical preparation with the EdgeEndox7 rotary system (Albuquerque, NM, USA), and Reciprocation Group (RG) (n = 10), treated with the EdgeOne Fire reciprocating system (Albuquerque, NM, USA). Apical fluid (AF) samples were collected, and SP levels were quantified through radioimmunoassay. POP was assessed using the Numerical Rating Scale (NRS) at various time intervals (preoperatively, 6 h, 12 h, 24 h, 48 h, and 72 h). Data were statistically analyzed utilizing the independent t-test, Mann-Whitney U test, Friedman's test, and Nemenyi post hoc test.ResultsThere was a significant increase in SP levels in the reciprocating group compared to the continuous rotation group (P ≤ 0.05). Additionally, patients in the reciprocating group reported significantly higher POP levels (P ≤ 0.05) at all measured intervals (6 h, 12 h, 24 h, and 48 h), with both groups exhibiting similar pain level reductions at the 72-hour mark.ConclusionOur findings suggest that continuous rotation kinematics in root canal preparation leads to a considerable reduction in SP expression and POP.Trial registrationThe study protocol was retrospectively registered on the www.Clinicaltrialsgov database (NCT06081335) at (13/10/2023) after the approval of the Ethics Committee, Faculty of Dentistry, Ain Shams University (FDASU-RecIM012135).
| S-EPMC10792914 | biostudies-literature
Project description:BACKGROUND:Numerical anchoring occurs when exposure to a numeric quantity influences a person's subsequent judgment involving other quantities. This could be applicable to the evaluation of pain, where exposure to an unrelated number before the evaluation of pain could influence pain ratings. OBJECTIVE:This study aimed to determine whether exposure to a random numeric anchor influences subsequent pain intensity ratings of a hypothetical patient. METHODS:In this study, 385 participants read a vignette describing a patient with chronic pain before being randomly assigned to one of four groups. Groups 1 and 2 spun an 11-wedge number wheel (0-10), which was, unbeknown to the participants, programmed to stop on a high number (8) or a low number (2), respectively. Group 3 spun a similar letter wheel (A-K), which was programmed to stop on either the letter C or I (control 1). Group 4 did not spin a wheel (control 2). Participants were then asked to rate the patient's pain intensity using a 0 to 10 numeric rating scale. RESULTS:The high-number group rated the patient's pain (median 8, IQR 2) significantly higher than the letter wheel control (median 7, IQR 2; P=.02) and the low-number group (median 6, IQR 2; P<.001). The low-number group rated the pain significantly lower than controls 1 and 2 (median 7, IQR 2; both P=.045). CONCLUSIONS:Pain ratings were influenced by prior exposure to a random number with no relevant information about the patient's pain, indicating anchoring had occurred. However, contrary to the traditional definition of anchoring where anchoring occurs even when participants are unaware of the anchor's influence, in this study, the anchoring effect was seen only in participants who believed that the anchor had influenced them. This suggests that anchoring effects could potentially occur among health care providers tasked with evaluating a patient's pain and should be evaluated further.
| S-EPMC7091028 | biostudies-literature
Project description:STUDY DESIGN:Randomized controlled trial. PURPOSE:The purpose of this study was to compare pregabalin and gabapentin for mean postoperative visual analog score (VAS) for pain in patients undergoing single-level lumbar microdiscectomy for intervertebral disc prolapse at a tertiary care hospital. OVERVIEW OF LITERATURE:Pregabalin has a superior pharmacokinetic profile and analgesic effect at lower doses than gabapentin; however, analgesic efficacy must be established during the perioperative period after lumbar spine surgery. METHODS:This randomized controlled trial was carried out at our institute from February to October 2011 on 78 patients, with 39 participants in each study group. Patients undergoing lumbar microdiscectomy were randomized to group A (gabapentin) or group B (pregabalin) and started on trial medicines one week before surgery. The VAS for pain was recorded at 24 hours and one week postoperatively. RESULTS:Both groups had similar baseline variables, with mean ages of 42 and 39 years in groups A and B, respectively, and a majority of male patients in each group. The mean VAS values for pain at 24 hours for gabapentin vs. pregabalin were comparable (1.97±0.84 vs. 1.6±0.87, respectively; p=0.087) as were the results at one week after surgery (0.27±0.45 vs. 0.3±0.46, respectively; p=0.79). None of the patients required additional analgesia postoperatively. After adjusting for age and sex, the VAS value for group B patients was 0.028 points lower than for group A patients, but this difference was not statistically significant (p=0.817, R2=0.018). CONCLUSIONS:Pregabalin is equivalent to gabapentin for the relief of postoperative pain at a lower dose in patients undergoing lumbar microdiscectomy. Therefore, other factors, such as dose, frequency, cost, pharmacokinetics, and side effects of these medicines, should be taken into account whenever it is prescribed.
| S-EPMC5326739 | biostudies-literature
Project description:Aim. A double-blind, randomized, placebo-controlled trial was designed to evaluate the efficacy of continuous intraoperative infusion of S(+)-ketamine under intravenous anesthesia with target-controlled infusion of remifentanil and propofol for postoperative pain control. Methods. Forty-eight patients undergoing laparoscopic cholecystectomy were assigned to receive continuous S(+)-ketamine infusion at a rate of 0.3?mg·kg(-1)·h(-1) (n = 24, intervention group) or an equivalent volume of saline at the same rate (n = 24, placebo group). The same target-controlled intravenous anesthesia was induced in both groups. Pain was assessed using a 0 to 10 verbal numeric rating scale during the first 12 postoperative hours. Pain scores and morphine consumption were recorded in the postanesthesia care unit (PACU) and at 4 and 12 hours after surgery. Results. Pain scores were lower in the intervention group at all time points. Morphine consumption did not differ significantly between groups during PACU stay, but it was significantly lower in the intervention group at each time point after PACU discharge (P = 0.0061). At 12 hours after surgery, cumulative morphine consumption was also lower in the intervention group (5.200 ± 2.707) than in the placebo group (7.525 ± 1.872). Conclusions. Continuous S(+)-ketamine infusion during laparoscopic cholecystectomy under target-controlled intravenous anesthesia provided better postoperative pain control than placebo, reducing morphine requirement. Trial Registration. This trial is registered with ClinicalTrials.gov NCT02421913.
| S-EPMC4755104 | biostudies-literature
Project description:BackgroundIt is unclear whether regional anesthesia with infraclavicular nerve block or general anesthesia provides better postoperative analgesia after distal radial fracture fixation, especially when combined with regular postoperative analgesic medications. The aim of this study was to compare the postoperative analgesic effects of regional versus general anesthesia.MethodsIn this prospective, observer blinded, randomized controlled trial, 52 patients undergoing distal radial fracture fixation received either general anesthesia (n = 26) or regional anesthesia (infraclavicular nerve block, n = 26). Numerical rating scale pain scores, analgesic consumption, patient satisfaction, adverse effects, upper limb functional scores (Patient-Rated Wrist Evaluation, QuickDASH), health related quality of life (SF12v2), and psychological status were evaluated after surgery.ResultRegional anesthesia was associated with significantly lower pain scores both at rest and with movement on arrival to the post-anesthetic care unit; and at 1, 2, 24 and 48 h after surgery (p ≤ 0.001 at rest and with movement). Morphine consumption in the post-anesthetic care unit was significantly lower in the regional anesthesia group (p<0.001). There were no differences in oral analgesic consumption. Regional anesthesia was associated with lower incidences of nausea (p = 0.004), and vomiting (p = 0.050). Patient satisfaction was higher in the regional anesthesia group (p = 0.003). There were no long-term differences in pain scores and other patient outcomes.ConclusionRegional anesthesia with ultrasound guided infraclavicular nerve block was associated with better acute pain relief after distal radial fracture fixation, and may be preferred over general anesthesia.Trial registrationBefore subject enrollment, the study was registered at ClinicalTrials.gov (NCT03048214) on 9th February 2017.
| S-EPMC7254671 | biostudies-literature
Project description:Postoperative pain after major open gynecologic surgeries requires appropriate pain management.This study aimed at comparing perioperative patient controlled epidural analgesia (PCEA) and patient controlled intravenous analgesia (PCA) after gynecologic oncology surgeries.In this clinical trial study, 90 patients with American society of anesthesiologists (ASA) class I or II scheduled for gynecologic oncologic surgeries were randomly allocated to two groups (45 patients each group) to receive: patient-controlled epidural analgesia with bupivacaine and fentanyl (PCEA group), or patient controlled intravenous analgesia (IV PCA group) with fentanyl, pethidine and ondansetron. Postoperative pain was assessed over 48 hours using the visual analog scale (VAS). The frequency of rescue analgesia was recorded. Occurrence of any concomitant events such as nausea, vomiting, ileus, purities, sedation and respiratory complications were recorded postoperatively.There were no statistically significant differences in demographic data including; age, weight, ASA physical status, duration of surgery, intraoperative bleeding, and the amount of blood transfusion (P > 0.05), between the two studied groups. Severity of postoperative pain was not significantly different between the two groups (P > 0.05); however, after first patient mobilization, pain was significantly lower in the epidural group than the IV group (P < 0.001). There was no significant difference between the two groups regarding the incidence of complications such as nausea, vomiting, purities or ileus (P > 0.05). Nevertheless, the incidence and severity of sedation was significantly higher in the IV group (P < 0.001). Respiratory depression was higher in the IV group than the epidural group; this difference, however, was not significant (P = 0.11). In the epidural group, only 10 patients (22.2%) had mild and transient lower extremities parenthesis.Both intravenous and epidural analgesic techniques with combination of analgesics provide proper postoperative pain control after major gynecologic cancer surgeries without any significant complications. Regarding lower sedative and respiratory depressant effects of epidural analgesia, it seems that this method is a safer technique for postoperative pain relief in these patients.
| S-EPMC4644303 | biostudies-other
Project description:Background: Blocking the action of the pro-inflammatory cytokine interleukin-1 (IL-1) reduces beta-cell secretory dysfunction and apoptosis in vitro, diabetes incidence in animal models of Type 1 diabetes mellitus (T1D), and glycaemia via improved beta-cell function in patients with T2D. We hypothesised that canakinumab, a monoclonal antibody to IL-1B, improves beta-cell function in patients with new-onset T1D. Methods: In an individually randomised, two-group parallel trial involving 12 sites in US, 69 patients aged 6-45 with T1D, < 12 weeks of symptoms, and assigned by centralised computer-generated blocked randomisation with locked computer-file concealment to treatment with 2 mg/kg (maximum 300 mg) canakinumab (n=45) or placebo (n=22) monthly for 12 months as add-on to conventional therapy. Participants and care-givers, but not data monitoring unit, were masked to group assignment. The primary end-point was change in the two-hour area-under-the-curve C-peptide response to MMT 12 months.
2015-10-01 | GSE68049 | GEO