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Preoperative versus postoperative ultrasound-guided rectus sheath block for improving pain, sleep quality and cytokine levels of patients with open midline incisions undergoing transabdominal gynaecological operation: study protocol for a randomised controlled trial.

ABSTRACT: Rectus sheath block (RSB) is used for postoperative pain relief in patients undergoing abdominal surgery with midline incision. Preoperative RSB has been shown to be effective, but it has not been compared with postoperative RSB. The aim of the present study is to evaluate postoperative pain, sleep quality and changes in the cytokine levels of patients undergoing gynaecological surgery with RSB performed preoperatively versus postoperatively.This study is a prospective, randomised, controlled (randomised, parallel group, concealed allocation), single-blinded trial. All patients undergoing transabdominal gynaecological surgery will be randomised 1:1 to the treatment intervention with general anaesthesia as an adjunct to preoperative or postoperative RSB. The objective of the trial is to evaluate postoperative pain, sleep quality and changes in the cytokine levels of patients undergoing gynaecological surgery with RSB performed preoperatively (n?=?32) versus postoperatively (n?=?32). All of the patients, irrespective of group allocation, will receive patient-controlled intravenous analgesia (PCIA) with oxycodone. The primary objective is to compare the interval between leaving the post-anaesthesia care unit and receiving the first PCIA bolus injection on the first postoperative night between patients who receive preoperative versus postoperative RSB. The secondary objectives will be to compare (1) cumulative oxycodone consumption at 24 hours after surgery; (2) postoperative sleep quality, as measured using a BIS-Vista monitor during the first night after surgery; and (3) cytokine levels (interleukin-1, interleukin-6, tumour necrosis factor-? and interferon-?) during surgery and at 24 and 48 hours postoperatively.Clinical experience has suggested that RSB is a very effective postoperative analgesic technique, and we will answer the following questions with this trial. Do preoperative block and postoperative block have the same duration of analgesic effects? Can postoperative block extend the analgesic time? The results of this study could have actual clinical applications that could help to reduce postoperative pain and shorten hospital stays.Current Controlled Trials NCT02477098 15 June 2015.

SUBMITTER: Jin F

PROVIDER: S-EPMC4676186 | biostudies-literature | 2015 Dec

REPOSITORIES: biostudies-literature

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Preoperative versus postoperative ultrasound-guided rectus sheath block for improving pain, sleep quality and cytokine levels of patients with open midline incisions undergoing transabdominal gynaecological operation: study protocol for a randomised controlled trial.

Jin Feng F Li Xiao-Qian XQ Tan Wen-Fei WF Ma Hong H Lu Huang-Wei HW

Trials 20151210

<h4>Background</h4>Rectus sheath block (RSB) is used for postoperative pain relief in patients undergoing abdominal surgery with midline incision. Preoperative RSB has been shown to be effective, but it has not been compared with postoperative RSB. The aim of the present study is to evaluate postoperative pain, sleep quality and changes in the cytokine levels of patients undergoing gynaecological surgery with RSB performed preoperatively versus postoperatively.<h4>Methods/design</h4>This study i ...[more]

PMID: 26652009

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Project description:BackgroundNerve block is usually performed before surgery because it inhibits reflection of the skin incision and reduces the amount of intraoperative anesthetic used. We hypothesized that performing rectus sheath block (RSB) after surgery would result in a longer duration of the analgesic effects and have a subtle influence on sleep time after surgery but that it would not decrease the perioperative cytokine levels of patients undergoing gynecological surgery.MethodsA randomized, double-blinded, controlled trial was conducted from October 2015 to June 2016. Seventy-seven patients undergoing elective transabdominal gynecological surgery were randomly assigned to the following two groups: a general anesthesia group who received 0.5% ropivacaine hydrochloride RSB preoperatively and saline RSB postoperatively, and another group who received the opposite sequence. The objective of the trial was to evaluate the postoperative pain, sleep and changes in cytokine levels of patients during the postoperative 48 h.ResultsA total of 61 female patients (mean age: 50 years; range: 24-65 years) were included in the final study sample. There was no significant difference in the pain, consumption of oxycodone, or time to first administration of patient-controlled intravenous analgesia between the two groups. The postoperative sleep stages N2 and N3 were increased by 52.9 and 29.1 min per patient, respectively, in the preoperative RSB group compared with those in the postoperative group. The preoperative IL-6 concentration in the preoperative RSB group was lower than that in the same group at the end of surgery and 24 h postoperatively.ConclusionsWe concluded that preoperative RSB might preserve postoperative sleep by inhibiting the increase of IL-6 without shortening the analgesia time compared with postoperative RSB in female patients undergoing elective midline incision transabdominal gynecological surgery.Trial registrationClinicalTrials.gov , NCT02477098 , registered on 15 June 2015.

Project description:Intervention1: Rectus sheath block: A USG machine with linear array probe (5-12MHz) with an imaging depth of 4-6cm will be used for performing the block. The ultrasound probe will be placed transverse on abdomen, immediately lateral (3 cm) to umbilicus. A 20-gauge needle will be inserted in-plane in a medial to lateral orientation, through the subcutaneous tissue, to pierce through the anterior rectus sheath. Upon identification of the rectus muscle and hyperechoic twin lines deep to it (posterior rectus sheath and fascia transversalis) in the ultrasound image the needle tip will be advanced to the desired position, posterior to the rectus muscle and above the underlying posterior rectus sheath under direct vision. Following conï¬?rmation of the correct position of the needle tip with hydro dissection of the rectus muscle away from the posterior rectus by administration of 0.51ml of normal saline; 20ml of 0.25% bupivacaine will be administered for block performance. The procedure will be repeated on the opposite side. Intervention2: oblique subcostal Transversus abdominis plane block: A USG linear array probe with high- or an intermediate-frequency linear probe of 35 to 40 mm will provide adequate imaging. A needle of up to 15 to 20 cm in length , bend into a slight curve will be required , decribed by Hebbard et al .15 The operator will stand on the left side of the patient in the supine position, and both sides are blocked from this position, with the right hand holding the needle and the left hand holding the probe. To perform the block, the rectus abdominis and underlying transversus abdominis muscles will be identified near the costal margin and xyphoid. Local anesthetic is injected incrementally in the TAP (hydrodissection) by a needle passing along the obliq Primary outcome(s): â?¢To assess the analgesic efficacy of rectus sheath block. â?¢To assess the analgesic efficacy of oblique subcostal TAP block. â?¢To compare the analgesic efficacy of both blocks. Timepoint: 24 hrs Study Design: Randomized, Parallel Group Trial Method of generating randomization sequence:Coin toss, Lottery, toss of dice, shuffling cards etc Method of allocation concealment:An Open list of random numbers Blinding and masking:Participant and Investigator Blinded

Project description:BackgroundRectus sheath catheter analgesia (RSCA) and thoracic epidural analgesia (TEA) are both used for analgesia following laparotomy. The aim was to compare the analgesic effectiveness of RSCA with TEA after laparotomy for elective colorectal and urological surgery.MethodsPatients undergoing elective midline laparotomy were randomized in a non-blinded fashion to receive RSCA or TEA for postoperative analgesia at a single UK teaching hospital. The primary quantitative outcome measure was dynamic pain score at 24 h after surgery. A nested qualitative study (reported elsewhere) explored the dual primary outcome of patient experience and acceptability. Secondary outcome measures included rest and movement pain scores over 72 h, functional analgesia, analgesia satisfaction, opiate consumption, functional recovery, morbidity, safety, and cost-effectiveness.ResultsA total of 131 patients were randomized: 66 in the RSCA group and 65 in the TEA group. The median (interquartile range; i.q.r.) dynamic pain score at 24 h was significantly lower after TEA than RSCA (33 (11-60) versus 50.5 (24.50-77.25); P = 0.018). Resting pain score at 72 h was significantly lower after RSCA (4.5 (0.25-13.75) versus 12.5 (2-13); P = 0.019). Opiate consumption on postoperative day 3 (median (i.q.r.) morphine equivalent 17 (10-30) mg versus 40 (13.25-88.50) mg; P = 0.038), hypotension, or vasopressor dependency (29.7 versus 49.2 per cent; P = 0.023) and weight gain to day 3 (median (i.q.r.) 0 (-1-2) kg versus 1 (0-3) kg; P = 0.046) were all significantly greater after TEA, compared with RSCA. There were no significant differences between groups in other secondary outcomes, although more participants experienced serious adverse events after TEA compared with RSCA, which was also the more cost-effective.ConclusionsTEA provided superior initial postoperative analgesia but only for the first 24 h. By 72 hours RSCA provides superior analgesia, is associated with a lower incidence of unwanted effects, and may be more cost-effective.

Dataset Information

Preoperative versus postoperative ultrasound-guided rectus sheath block for improving pain, sleep quality and cytokine levels of patients with open midline incisions undergoing transabdominal gynaecological operation: study protocol for a randomised controlled trial.

Publications

Preoperative versus postoperative ultrasound-guided rectus sheath block for improving pain, sleep quality and cytokine levels of patients with open midline incisions undergoing transabdominal gynaecological operation: study protocol for a randomised controlled trial.

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