Dataset Information

The usefulness of dual channel elastomeric pump for intravenous patient-controlled analgesia in geriatrics: a randomized, double-blind, prospective study.

ABSTRACT:

Background

Intravenous patient-controlled analgesia (IV-PCA) is often used in the postoperative period. However, determining an appropriate opioid dose is difficult. A previous study suggested the usefulness of variable-rate feedback infusion. In this study, we used a dual-channel elastomeric infusion pump to provide changes in PCA infusion rate by pain feedback.

Methods

Ninety patients undergoing orthopedic surgery of American Society of Anesthesiologists grade I-III and 65 to 79 years of age participated in the study. All patients were given a dual-chamber PCA. Patients were randomly allocated to a treatment group (Group D; PCA drugs divided into both chambers) or control group (Group C; PCA drugs only in the constant flow chamber with normal saline in the adjustable flow chamber). The primary outcome was the amount of fentanyl consumption via PCA bolus. The secondary outcome variables were pain score, total fentanyl consumption, rescue analgesic use, patient satisfaction, recovery scores, and adverse events including postoperative nausea and vomiting (PONV).

Results

Group D showed decreased fentanyl consumption of the PCA bolus, a decrease in rescue analgesic use, and better patient satisfaction compared with group C. The incidence of PONV was much higher in group C. There was no difference in other adverse events.

Conclusions

We showed the usefulness of dual chamber IV-PCA to change the flow rate related to pain feedback without any complications. Our results suggest a noble system that might improve existing IV-PCA equipment.

Trial registration

The study registered at UMIN clinical trial registry (registered date: 05/03/2020, registration number: UMIN000039702 ).

SUBMITTER: Lee CH

PROVIDER: S-EPMC9261015 | biostudies-literature |

REPOSITORIES: biostudies-literature

ACCESS DATA

Similar Datasets

Project description:BackgroundA newly designed intravenous patient-controlled analgesia (PCA) device with a dual-channel elastomeric infusion pump has been recently introduced. One channel is a continuous line with a constant flow rate basal infusion, while the other channel has an adjustable flow rate and bolus function and is labeled as a selector-bolus channel. This study compared dual and single-channel intravenous PCA in terms of clinical effect and quality of recovery.MethodsEighty-four patients undergoing total laparoscopic hysterectomy were randomly allocated to a 1-channel group (n = 41) or a 2-channel group (n = 43). Only the selector-bolus channel was utilized, but the continuous channel was not utilized in the 1-channel group, but both channels were utilized in the 2-channel group. In the 1-channel group, 16 μg/kg of fentanyl, 2 mg/kg of ketorolac, and 12 mg of ondansetron with normal saline were administered to the selector-bolus channel and normal saline only in the continuous channel for blinding. In the 2-channel group, 16 μg/kg of fentanyl was administered to the selector-bolus channel, and ketorolac (2 mg/kg) and ondansetron (12 mg) were administered via the continuous channel. The quality of recovery was evaluated preoperatively and 24 h postoperatively using the Quality of Recovery-40 (QoR-40). Cumulative PCA consumption, postoperative pain rated using the numeric rating scale (NRS; during rest/cough), and postoperative nausea were evaluated 6, 12, 24, 36, and 48 h after surgery. Incidence of vomiting and use of antiemetics and rescue analgesics was measured.ResultsThe 24-h postoperative QoR-40 score was higher in the 2-channel group than in the 1-channel group (P=0.031). The incidence of nausea at 12 h and 36 h was significantly higher in the 1-channel group (P=0.043 and 0.040, respectively), and antiemetic use was more frequent in the 1-channel group (P=0.049). Patient satisfaction was higher in the 2-channel group (P=0.036). No significant differences were observed in pain scores during resting/cough or cumulative PCA consumption.ConclusionsThe 2-channel PCA showed better patient satisfaction with higher QoR-40 during the recovery compared with the 1-channel PCA. Better satisfaction was associated with lower nausea and reduced rescue antiemetics by maintaining the infusion of adjuvant analgesic agents and antiemetic agents constantly by utilizing dual channels.Trial registrationRegistered at ClinicalTrials.gov , NCT04082039 on 9 September 2019.

Project description:BackgroundThe efficacy of intravenous (IV) acetaminophen compared with its oral formulation for postoperative analgesia is unknown. We hypothesized that the addition of acetaminophen to a multimodal analgesia regimen would provide improved pain management in patients after total knee arthroplasty (TKA) and that the effect of acetaminophen would be variable based on the route of delivery.MethodsThe study was a single-center, randomized, double-blinded, placebo-controlled clinical trial on the efficacy of IV vs oral acetaminophen in patients undergoing unilateral TKA. One hundred seventy-four subjects were randomized to one of the 3 groups: IV acetaminophen group (IV group, n = 57) received 1 g IV acetaminophen and oral placebo before postanesthesia care unit (PACU) admission; oral acetaminophen group (PO group, n = 58) received 1 g oral acetaminophen and volume-matched IV normal saline; placebo group (Placebo group, n = 59) received oral placebo and volume-matched IV normal saline. Pain scores were obtained every 15 minutes during PACU stay. Average pain scores, maximum pain score, and pain scores before physical therapy were compared among the 3 groups. Secondary outcomes included total opiate consumption, time to PACU discharge, time to rescue analgesia, and time to breakthrough pain.ResultsThe average PACU pain score was similar in the IV group (0.56 ± 0.99 [mean ± standard deviation]) compared with the PO group (0.67 ± 1.20; P = .84) and Placebo group (0.58 ± 0.99; P = .71). Total opiate consumption at 6 hours (0.47 mg hydromorphone equivalents ± 0.56 vs 0.54 ± 0.53 vs 0.54 ± 0.61; P = .69) and at 24 hours (1.25 ± 1.30 vs 1.49 ± 1.34 vs 1.36 ± 1.31; P = .46) were also similar between the IV, PO, and Placebo groups. No significant differences were found between all groups for any other outcome.ConclusionNeither IV nor oral acetaminophen provides additional analgesia in the immediate postoperative period when administered as an adjunct to multimodal analgesia in patients undergoing TKA in the setting of a spinal anesthetic.

Project description:IntroductionBreast surgery may be associated with significant postoperative pain and if not adequately treated, may lead to the development of chronic post-surgical pain. This necessitates the use of effective management, involving the use a multimodal analgesia regimen for the management of post breast surgery pain. The analgesic effect of perioperative use of dexamethasone has been explored but findings have been inconsistent.AimThe aim of this study was to determine the postoperative analgesic enhancing effect of a single preoperative dose of dexamethasone on patients undergoing breast surgery at a tertiary hospital in Ghana.Materials and methodsThis was a prospective, double-blind, placebo-controlled study involving 94 consecutively recruited patients. Patients were randomized into two groups: dexamethasone (n = 47) and placebo (n = 47). Patients in the dexamethasone group had 8mg (2 mL of 4 mg/mL) dexamethasone and those in the placebo group had 2 mL of saline administered intravenously just before induction of anaesthesia. All patients received a standard general anaesthesia with endotracheal intubation. The numerical rating score (NRS), time to first analgesic request and the total opioid consumed in the first 24 h were recorded.ResultsPatients receiving dexamethasone had lower NRS scores at all measured time points but this was significant only at 8 h post-surgery (P = 0.037). The time to first rescue analgesia was significantly prolonged in the dexamethasone group (339.26 ± 312.90 min vs. 182.10 ± 166.72 min; P = 0.020). However, the mean total opioid (pethidine) consumed in the first 24 h postoperatively was not significantly different between the dexamethasone and control groups (113.75 ± 51.35 mg vs. 100.00 ± 60.93 mg; P = 0.358).ConclusionA single preoperative dose of 8mg dexamethasone given intravenously, reduces postoperative pain compared to placebo, significantly reduces the time to first analgesia but not the total opioid consumed in the first 24 h post breast surgery.

Project description:BackgroundLocal anesthetic wound infusion has become an invaluable technique in multimodal analgesia. The effectiveness of wound infusion of 0.2% ropivacaine delivered by patient controlled analgesia (PCA) pump has not been evaluated in minimally invasive cardiac surgery. We tested the hypothesis that 0.2% ropivacaine wound infusion by PCA pump reduces the cumulative dose of opioid needed in the first 48 h after minithoracothomy aortic valve replacement (AVR).MethodsIn this prospective, randomized, double-blind, placebo-controlled study, 70 adult patients (31 female and 39 male) were analyzed. Patients were randomized to receive 0.2% ropivacaine or 0.9% saline wound infusion by PCA pump for 48 h postoperatively. PCA pump was programmed at 5 ml h- 1 continuously and 5 ml of bolus with 60 min lockout. Pain levels were assessed and recorded hourly by Numeric Rating Scale (NRS). If NRS score was higher than three the patient was administered 3 mg of opioid piritramide repeated and titrated as needed until pain relief was achieved. The primary outcome was the cumulative dose of the opioid piritramide in the first 48 h after surgery. Secondary outcomes were frequency of NRS scores higher than three, patient's satisfaction with pain relief, hospital length of stay, side effects related to the local anesthetic and complications related to the wound catheter.ResultsThe cumulative dose of the opioid piritramide in the first 48 h after minithoracotomy AVR was significantly lower (p < 0.001) in the ropivacaine (R) group median 3 mg (IQR 6 mg) vs. 9 mg (IQR 9 mg). The number of episodes of pain where NRS score was greater than three median 2 (IQR 2), vs 3 (IQR 3), (p = 0.002) in the first 48 h after surgery were significantly lower in the ropivacaine group, compared to control. Patient satisfaction with pain relief in our study was high. There were no wound infections and no side-effects from the local anesthetic.ConclusionsWound infusion of local anesthetic by PCA pump significantly reduced opioid dose needed and improves pain control postoperatively. We have also shown that it is a feasible method of analgesia and it should be considered in the multimodal pain control strategy following minimally invasive cardiac surgery.Trial registrationClinicalTrials.gov NCT03079830 , date of registration: March 15, 2017. Retrospecitvely registered.

Project description:BackgroundHemorrhoidectomy is associated with intense postoperative pain that requires multimodal analgesia. It includes nonsteroidal anti-inflammatory drugs (NSAIDs), acetaminophen, and local anesthetics to reach adequate pain control. There are data in literature preemptive analgesia could decrease postoperative pain after hemorrhoidectomy. The aim of this study is to assess the efficacy of preemptive analgesia with ketoprofen 100 mg 2 h before procedure per os with spinal anesthesia to decrease postoperative pain according to visual analog scale and to reduce the opioids and other analgesics consumption.MethodsPatients of our clinic who meet the following inclusion criteria are included: hemorrhoids grade III-IV and the planned Milligan-Morgan hemorrhoidectomy. After signing the consent all participants are randomly divided into 2 groups: the first one gets a tablet with 100 mg ketoprofen, the second one gets a tablet containing starch per os 2 h before surgery (72 participants per arm). Patients of both arms receive spinal anesthesia and undergo open hemorrhoidectomy. Following the procedure the primary and secondary outcomes are evaluated: opioid administration intake, the pain at rest and during defecation, duration, and frequency of other analgesics intake, readmission rate, overall quality of life, time from the procedure to returning to work, and the complications rate.DiscussionMultimodality pain management has been shown to improve pain control and decrease opioid intake in patients after hemorrhoidectomy in several studies. Gabapentin can be considered as an alternative approach to pain control as NSAIDs have limitative adverse effects. Systemic admission of ketorolac with local anesthetics also showed significant efficacy in patients undergoing anorectal surgery. We hope to prove the efficacy of multimodal analgesia including preemptive one for patients undergoing excisional hemorrhoidectomy that will help to hold postoperative pain levels no more than 3-4 points on VAS with minimal consumption of opioid analgesics.Trial registrationClinicalTrial.gov NCT04361695 . Registered on April 24, 2020, version 1.0.

Project description:UnlabelledWe conducted a randomized, double-blind, placebo-controlled, crossover study at a single center in South Africa, to ascertain whether amitriptyline is an effective analgesic for painful HIV-associated sensory neuropathy of moderate to severe intensity in: i) antiretroviral drug naive individuals, and ii) antiretroviral drug users. 124 HIV-infected participants (antiretroviral drug naive = 62, antiretroviral drug users = 62) who met the study criteria for painful HIV-associated sensory neuropathy were randomized to once-daily oral amitriptyline (titrated to a median: interquartile range of 50: 25-50 mg) or placebo for six weeks, followed by a three-week washout period and subsequent treatment crossover. The primary outcome measure was change from baseline in worst pain intensity of the feet (measured by participant self-report using an 11-point numerical pain rating scale) after six weeks of treatment. 122 of 124 participants completed all study visits and were included in the analysis of the primary outcome. In the antiretroviral drug-naive group (n = 61) there was no significant difference in the mean change in pain score from baseline after six weeks of treatment with placebo or amitriptyline [amitriptyline: 2.8 (SD 3.3) vs. placebo: 2.8 (3.4)]. Similarly, there was no significant difference in the change in pain score after six weeks of treatment with placebo or amitriptyline in the antiretroviral drug-user group (n = 61) [amitriptyline: 2.7 (3.3) vs. placebo: 2.1 (2.8)]. Controlling for period effects and treatment order effects did not alter the outcome of the analyses. Nor did analyzing the intention-to-treat cohort (missing data interpolated using baseline observation carried forward) alter the outcome of the analyses. In summary, amitriptyline, at the doses used here, was no more effective than an inactive placebo at reducing pain intensity in individuals with painful HIV-associated sensory neuropathy of moderate to severe intensity, irrespective of whether they were on antiretroviral therapy or not.Trial registrationISRCTN 54452526.