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Randomized controlled trial of transcutaneous electrical nerve stimulation for pain relief during transvaginal oocyte retrieval using conscious sedation: study protocol for a randomized controlled trial.

ABSTRACT: BACKGROUND:Transvaginal oocytes retrieval is an essential step in in-vitro fertilization treatment. There are different pain relief methods, but none has been shown to be superior than the others. Transcutaneous electrical nerve stimulation (TENS) is a non-pharmacological and non-invasive pain relief method. This study aims to compare the pain levels experienced by the women using the conscious sedation and those who had TENS in addition to conscious sedation. METHODS AND ANALYSIS:This is a double-blinded randomized trial that will be carried out in a university-assisted conception unit. Women who will undergo oocyte retrieval under conscious sedation will be recruited. After randomization, women will be allocated to either the active TENS group or placebo TENS group (the TENS machine will not emit active impulse), in addition to the paracervical block and conscious sedation. The primary outcome is pain levels of women during the retrieval assessed by the visual analog scale. Secondary outcomes include satisfaction of women and postoperative side effects. DISCUSSION:TENS is an effective non-pharmacological and non-invasive method for pain relief in a number of clinical conditions. Both women and assisted conception unit can benefit if the addition of non-invasive, simple, and low-cost TENS application is proven to be superior than using conscious sedation and paracervical block alone. TRIAL REGISTRATION:ClinicalTrials.gov, NCT03472430 . Registered on 3 May 2018.

SUBMITTER: Wong QHY

PROVIDER: S-EPMC6458783 | biostudies-literature | 2019 Apr

REPOSITORIES: biostudies-literature

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Randomized controlled trial of transcutaneous electrical nerve stimulation for pain relief during transvaginal oocyte retrieval using conscious sedation: study protocol for a randomized controlled trial.

Wong Queenie Ho Yan QHY Lui Man Wa MW Yung Sofie Shuk Fei SSF Ko Jennifer Ka Yee JKY Li Raymond Hang Wun RHW Ng Ernest Hung Yu EHY

Trials 20190411 1

<h4>Background</h4>Transvaginal oocytes retrieval is an essential step in in-vitro fertilization treatment. There are different pain relief methods, but none has been shown to be superior than the others. Transcutaneous electrical nerve stimulation (TENS) is a non-pharmacological and non-invasive pain relief method. This study aims to compare the pain levels experienced by the women using the conscious sedation and those who had TENS in addition to conscious sedation.<h4>Methods and analysis</h4 ...[more]

PMID: 30971304

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Project description:ObjectiveTo study pain in women undergoing oocyte retrieval with a reduced needle (20/17 gauge) compared to a standard needle (16 gauge).DesignSingle-center randomized controlled trial.SettingFertility clinic.PatientsWomen undergoing their first oocyte retrieval for in vitro fertilization or intracytoplasmic sperm injection.InterventionsOocyte retrieval with a reduced needle (20/17 gauge) or with a standard needle (16 gauge).Main outcome measuresThe primary outcome measure was intraoperative pain on an 11-point visual analogue scale (VAS). Secondary outcome measures included the following: dosage of fentanyl requested; pain at 5, 15 and 30 minutes after retrieval; and pain and analgesia until 4 days after retrieval.ResultsA total of 47 women were randomized for the reduced needle (RN) and 48 for the standard needle (SN). Pain scores were significantly lower during and after retrieval with the RN. During retrieval, mean VAS scores in the RN group were 4.3 versus 6.3 in the SN group. Pain remained significantly lower in the RN group after retrieval, with VAS-scores of 1.2 vs. 2.1 directly after retrieval, 0.0 versus 2.0 5 minutes after retrieval, and 0.0 versus 1.0 30 minutes after retrieval. In the RN group, three patients (6.4%) requested more fentanyl during the procedure, versus 16 (33.3%) in the SN group. A total of 79 patients submitted their follow-up questionnaire (response rate 83%). Pain on the first 2 days following retrieval was significantly less in the RN group, with VAS scores of 1.6 versus 2.4 in the SN group, and 1.2 versus 2.5. In line with this finding, fewer patients in the RN group took analgesia on the days after the procedure. This difference was statistically significant only on day 3.ConclusionUse of a thinner needle results in significantly and clinically relevant lower pain scores during oocyte retrieval, and patients in the reduced needle group requested significantly less analgesia during oocyte retrieval than patients in the standard needle group. Pain scores remained significantly lower up until 2 days after the procedure.Dutch trial registration numberNTR6064 (www.trialregister.nl).

Project description:BackgroundConscious sedation is regularly used in ambulatory surgery to improve patient outcomes, in particular patient satisfaction. Reports suggest that the addition of conscious sedation to local anesthesia for inguinal hernioplasty is safe and effective in improving patient satisfaction. No previous randomized controlled trial has assessed the benefit of conscious sedation in this regard.ObjectiveTo determine whether the addition of conscious sedation to local anesthesia improves patient satisfaction with inguinal hernioplasty.MethodsThis trial is designed as a single-center, randomized, placebo-controlled, blinded trial of 148 patients. Adult patients diagnosed with a reducible, unilateral inguinal hernia eligible for hernioplasty using local anesthesia will be recruited. The intervention will be the use of intravenous midazolam for conscious sedation. Normal saline will be used as placebo in the control group. The primary outcome will be patient satisfaction, measured using the validated Iowa Satisfaction with Anesthesia Scale. Secondary outcomes will include intra- and postoperative pain, operative time, volumes of sedative agent and local anesthetic used, time to discharge, early and late complications, and postoperative functional status.ResultsTo date, 171 patients have been recruited. Surgery has been performed on 149 patients, meeting the sample size requirements. Follow-up assessments are still ongoing. Trial completion is expected in August 2017.ConclusionsThis randomized controlled trial is the first to assess the effectiveness of conscious sedation in improving patient satisfaction with inguinal hernioplasty using local anesthesia. If the results demonstrate improved patient satisfaction with conscious sedation, this would support routine incorporation of conscious sedation in local inguinal hernioplasty and potentially influence national and international hernia surgery guidelines.Trial registrationClinicaltrials.gov NCT02444260; https://clinicaltrials.gov/ct2/show/NCT02444260 (Archived by WebCite at http://www.webcitation.org/6no8Dprp4).

Project description:BACKGROUND:Pain during labour is one of the most intense pain that women may experience in their lifetime. There are several non-pharmacological analgesic methods to relieve pain during labour, among them transcutaneous electrical nerve stimulation (TENS). TENS is a low-frequency electrotherapy technique, analgesic type, generally used in musculoskeletal pathology, but it has also come to be used as an alternative treatment during labour. The purpose of this study is to investigate the pain-relieving effect of a TENS application during labour and to find out the most effective dose. METHODS:This study is a randomized, double-blind, placebo-controlled trial. TENS therapy was initiated at the beginning of the active phase of labour. Participants were randomly assigned to three groups (21 per group: two active TENS and one placebo). Active TENS 1 intervention consisted in a constant frequency of 100-Hz, 100-?s, active TENS 2 intervention consisted in a varying high-frequency (80-100 Hz), 350 ?s, and in a placebo group, participants were connected to the TENS unit without electrical stimulation. TENS was applied with two self-adhesive electrodes placed parallel to the spinal cord (T10-L1 and S2-S4 levels). The primary outcome was pain intensity (0-10 cm) measured on a visual analogue scale (VAS) at several stages (at baseline and at 10 and 30 min later). Secondary outcomes included women's satisfaction (via the Care in Obstetrics: Measure for Testing Satisfaction scale). RESULTS:Sixty-three women participated. Regarding baseline characteristics, no differences were found among the three groups. The active TENS 2 group obtained an improvement with clinically significant VAS results (-?2.9, 95% confidence interval -?4.1 to -?1.6, p?<? 0.001). Regarding satisfaction, the results also revealed better results in the active TENS than in the placebo group. CONCLUSIONS:TENS with high frequencies modified in time as well as high pulse width are effective for relieving labour pain, and they are well considered by pregnant participants. TRIAL REGISTRATION:ClinicalTrials.gov, NCT03137251 . Registered on 2 May 2017.

Project description:Breast lumpectomy is usually performed under general or local anesthesia. To the best of our knowledge, whether conscious sedation with intranasal dexmedetomidine and local anesthesia is an effective anesthetic technique has not been studied. Thus, the present study aimed to investigate the effectiveness of conscious sedation with intranasal dexmedetomidine combined with local anesthesia in breast lumpectomy, and to identify its optimal dose. A prospective randomized, double-blinded, placebo-controlled, single-center study was designed, and patients undergoing breast lumpectomies were recruited based on the inclusion and exclusion criteria. All patients were randomly allocated to four groups: i) Local anesthesia with 0.9% intranasal saline (placebo); local anesthesia with ii) 1 µg.kg-1; iii) 1.5 µg.kg-1; or iv) 2 µg.kg-1 intranasal dexmedetomidine. The sedation status, pain relief, vital signs, adverse events, and satisfaction of patient and surgeon were recorded. Patients in the three dexmedetomidine groups were significantly more sedated and experienced less pain compared with the placebo group 45 min after intranasal dexmedetomidine administration and during 30 min in the post-anesthesia care unit. Patients in the 1.5 µg.kg-1 group were more sedated compared with the 1 µg.kg-1 group (without reaching statistical significance), whereas the 1.5 µg.kg-1 group exhibited a similar level of sedation 45 min after intranasal dexmedetomidine administration compared with the 2 µg.kg-1 group. In addition, patients in the 1 and 1.5 µg.kg-1 group experienced no adverse hemodynamic effects. Patient and surgeon satisfaction were greater in the 1.5 µg.kg-1 group compared with the 1 and 2 µg.kg-1 groups. Taken together, the results of the present study suggested that conscious sedation with intranasal dexmedetomidine and local anesthesia may be an effective anesthetic for breast lumpectomy surgery, and that the optimal dose for intranasal dexmedetomidine administration may be 1.5 µg.kg-1, as it resulted in good sedation and patient satisfaction without adverse effects.

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Randomized controlled trial of transcutaneous electrical nerve stimulation for pain relief during transvaginal oocyte retrieval using conscious sedation: study protocol for a randomized controlled trial.

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Randomized controlled trial of transcutaneous electrical nerve stimulation for pain relief during transvaginal oocyte retrieval using conscious sedation: study protocol for a randomized controlled trial.

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