Influence of Analgesic Technique on Post Operative Rehabilitation After Median Laparotomy

Official title

Influence of Analgesic Technique on Post Operative Rehabilitation After Median Laparotomy: Comparison Between Thoracic Epidural Anesthesia Versus Bilateral Rectus Sheath Block

Overview

Randomized controlled trial (1:1) in two parallel groups, multicentric, open-label, comparing two locoregional anesthesia (LRA) techniques as integral parts of multimodal analgesia: the control group will benefit from epidural anesthesia, while the experimental group will benefit from bilateral placement of catheters in the sheath of the rectus abdominis muscles.

Detailed description

Implementation of fast-track rehabilitation surgery was essential in patient care, specially in oncological point.

In this way, uses of the technic of local anesthesia, include epidural analgesia, was essential, but this one is associated with few complications. Emergence of new technic of anesthesia with a comparative analgesia and without side effects should be a better alternative than epidural analgesia. Thus, bilateral rectus sheath block has been reported to be effective in management of postoperative pain.

After signing of the informed consent, two postoperative analgesia techniques were investigated in patients undergoing midline laparotomy.

The main objective of this study is to compare the influence of analgesic technique on the Quality of Recovery-15 score. The study design was a prospective, randomized trial with 2 parallel arms (epidural analgesia vs bilateral rectus sheath block).

Interventions

• Drug Epidural analgesia
  All patients received local anesthesia (3-5 ml of 2% Lidocaine). During the preoperative induction of anaesthesia a catheter was inserted 4cm into the epidural space. The catheter will be load during the intervention (0.1 ml/kg/h). In postoperative situation, a patient controlled epidural analgesia was introduced with a debit adapted to the arterial pressure.
• Drug Bilateral rectus sheath block
  Bilateral rectus sheath block was performed Under general anesthesia and with ultrasound guidance. Rectus sheath block was inserted on each side of the abdomen. All patients received ropivacaine through elastomeric pump
• Procedure Laparotomy
  A midline sub or supra umbilical laparotomy or xypho-pubian laparotomy

Primary outcome measures

• Change in total QoR-15 score [Time frame: Postoperative day 2]

Secondary outcome measures (12)

• Change in total Qor-15 score on postoperative days 1 and 3 compared to the day before surgery [Time frame: Postoperative days 1, and 3]
• Efficacy of postoperative analgesia [Time frame: Day 0 and Postoperative days 1, 2, 3 and 30]
• Impact of arterial hypotension [Time frame: Postoperative days 1, 2 and 3]
• Impact of orthostatic hypotension [Time frame: Postoperative days 1, 2 and 3]
• Occurrence of nausea and/or vomiting [Time frame: Day 0, Postoperative days 1, 2 and 3 and at hospital discharge up to 30 days]
• Postoperative complications link to analgesic technique [Time frame: Postoperative days 1, 2 and 3]
• The length of stay [Time frame: at hospital discharge up to 30 days]
• Return to normal bowel function [Time frame: Postoperative days 1, 2 and 3 and at hospital discharge up to 30 days]
• The quantity of morphine or equivalent [Time frame: Day 0 and Postoperative days 1, 2 and 3]
• Urinary catheterization [Time frame: at hospital discharge up to 30 days]
• Total distance covered [Time frame: Postoperative days 1, 2 and 3]
• Failure to set up a catheter [Time frame: Postoperative day 1]

Eligibility criteria

Inclusion criteria

• ASA (American Society of Anesthesiologists) Class I-IV adult, with programmed midline laparotomy
• Have given an informed written consent
• Able to read and understand french language
• Affiliation to a social security system

Exclusion criteria

• Local anesthesic contraindication (allergy, porphyria, haemolytic anaemia, uncontrolled epilepsy, or severe cardiac conduction disorders) or TEA (coagulation disorders, progressive neurological disease, or severe spinal disorder),
• Epidural analgesia contraindication
• With impossibility to set up bilateral rectus sheath block
• Participation in another clinical study
• Pregnant women
• Patients deprived of their liberty by a judicial or administrative decision,
• Patients undergoing psychiatric care under articles L.3212-1 and L.3213-1 of the French Public Health Code

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Other

Study locations

France · 2 centers

• CHR Metz Thionville Hopital de Mercy — Metz
• CHR Metz-Thionville Hopital Bel Air — Thionville

Publications

• Maury T, Elnar A, Marchionni S, Frisoni R, Goetz C, Becret A. Effect of rectus sheath anaesthesia versus thoracic epidural analgesia on postoperative recovery quality after elective open abdominal surgery in a French regional hospital: the study protocol of a randomised controlled QoR-RECT-CATH trial. BMJ Open. 2023 May 23;13(5):e069736. doi: 10.1136/bmjopen-2022-069736. PMID 37221022

Identifiers

NCT: NCT04985695 · 2021-01-CHRMT

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗