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Thoracic Epidural analgesia versus Rectus Sheath Catheters for open midline incisions in major abdominal surgery within an enhanced recovery programme (TERSC): study protocol for a randomised controlled trial.

ABSTRACT: Thoracic epidural analgesia (TEA) is recommended for post-operative pain relief in patients undergoing major abdominal surgery via a midline incision. However, the effectiveness of TEA is variable with high failure rates reported post-operatively. Common side effects such as low blood pressure and motor block can reduce mobility and hinder recovery, and a number of rare but serious complications can also occur following their use.Rectus sheath catheters (RSC) may provide a novel alternative approach to somatic analgesia without the associated adverse effects of TEA. The aim of this study is to compare the efficacy of both techniques in terms of pain relief, patient experience, post-operative functional recovery, safety and cost-effectiveness.This is a single-centre randomised controlled non-blinded trial, which also includes a nested qualitative study. Over a two-year period, 132 patients undergoing major abdominal surgery via a midline incision will be randomised to receive either TEA or RSC for post-operative analgesia. The primary outcome measures pain scores on moving from a supine to a sitting position at 24 hours post wound closure, and the patient experience between groups evaluated through in-depth interviews. Secondary outcomes include pain scores at rest and on movement at other time points, opiate consumption, functional recovery, morbidity and cost-effectiveness.This will be the first randomised controlled trial comparing thoracic epidurals to ultrasound-guided rectus sheath catheters in adults undergoing elective midline laparotomy. The standardised care provided by an Enhanced Recovery Programme makes this a comparison between two complex pain packages and not simply two analgesic techniques, in order to ascertain if RSC is a viable alternative to TEA.Current Controlled Trials ISRCTN81223298 (16 January 2014).

SUBMITTER: Wilkinson KM

PROVIDER: S-EPMC4223757 | biostudies-literature | 2014 Oct

REPOSITORIES: biostudies-literature

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Thoracic Epidural analgesia versus Rectus Sheath Catheters for open midline incisions in major abdominal surgery within an enhanced recovery programme (TERSC): study protocol for a randomised controlled trial.

Wilkinson Kate M KM Krige Anton A Brearley Sarah G SG Lane Steven S Scott Michael M Gordon Anthony C AC Carlson Gordon L GL

Trials 20141021

<h4>Background</h4>Thoracic epidural analgesia (TEA) is recommended for post-operative pain relief in patients undergoing major abdominal surgery via a midline incision. However, the effectiveness of TEA is variable with high failure rates reported post-operatively. Common side effects such as low blood pressure and motor block can reduce mobility and hinder recovery, and a number of rare but serious complications can also occur following their use.Rectus sheath catheters (RSC) may provide a nov ...[more]

PMID: 25336055

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Project description:IntroductionEnhanced recovery after surgery (ERAS) protocols increase patient well-being while significantly reducing mortality, costs and length-of-stay after surgery. A key component is multimodal analgesia that prevents postoperative pain and facilitates early refeeding and mobilisation. Thoracic epidural analgesia (TEA) was long the gold standard for locoregional anaesthesia in anterior abdominal wall surgery. However, newer wall-block techniques such as rectus-sheath block (RSB) may be preferable because they are less invasive and may provide equivalent analgesia with fewer side effects. Since the evidence base remains limited, the Quality Of Recovery enhanced by REctus sheat CATHeter (QoR-RECT-CATH) randomised controlled trial (RCT) was designed to assess whether RSB elicits better postoperative rehabilitation than TEA after laparotomy.Methods and analysisThis open-label parallel-arm 1:1-allocated RCT will determine whether RSB is superior to TEA in 110 patients undergoing scheduled midline laparotomy in terms of postoperative rehabilitation quality. The setting is a regional French hospital that provides opioid-free anaesthesia for all laparotomies within an ERAS programme. Recruited patients will be ≥18 years, scheduled to undergo laparotomy, have American Society of Anesthesiologists (ASA) score 1-4 and lack contraindications to ropivacaine/TEA. TEA-allocated patients will receive an epidural catheter before surgery while RSB-allocated patients will receive rectus sheath catheters after surgery. All other pre/peri/postoperative procedures will be identical, including multimodal postoperative analgesia provided according to our standard of care. Primary objective is a change in total Quality-of-Recovery-15 French-language (QoR-15F) score on postoperative day (POD) 2 relative to baseline. QoR-15F is a patient-reported outcome measure that is commonly used to measure ERAS outcomes. The 15 secondary objectives include postoperative pain scores, opioid consumption, functional recovery measures and adverse events.Ethics and disseminationThe French Ethics Committee (Sud-Ouest et Outre-Mer I Ethical Committee) gave approval. Subjects are recruited after providing written consent after receiving the information provided by the investigator. The results of this study will be made public through peer-reviewed publication and, if possible, conference publications.Trial registration numberNCT04985695.

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: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.

Dataset Information

Thoracic Epidural analgesia versus Rectus Sheath Catheters for open midline incisions in major abdominal surgery within an enhanced recovery programme (TERSC): study protocol for a randomised controlled trial.

Publications

Thoracic Epidural analgesia versus Rectus Sheath Catheters for open midline incisions in major abdominal surgery within an enhanced recovery programme (TERSC): study protocol for a randomised controlled trial.

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