Influence of Analgesic Technique on Post Operative Rehabilitation After Median Laparotomy

NCT04985695 | Recruiting

• 1 other identifier: 2021-01-CHRMT
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Laparotomy

Keywords

postoperative rehabilitation

Outcome Measures

Primary Outcomes (1)

• Change in total QoR-15 score

  The Quality of Recovery-15 (QoR-15) included five dimensions: physical comfort, emotional state, pain, psychological support and physical independence. Each item was assessed using an 11-point numerical rating scale (for positive itel, 0="none of the time" to 10="all the time"; for negative items the scoring was reversed).

  Postoperative day 2

Secondary Outcomes (15)

• Change in total Qor-15 score on postoperative days 1 and 3 compared to the day before surgery

  Postoperative days 1, and 3

• Efficacy of postoperative analgesia

  Day 0 and Postoperative days 1, 2, 3 and 30

• Impact of arterial hypotension

  Postoperative days 1, 2 and 3

• Impact of orthostatic hypotension

  Postoperative days 1, 2 and 3

• Occurrence of nausea and/or vomiting

  Day 0, Postoperative days 1, 2 and 3 and at hospital discharge up to 30 days

Study Arms (2)

Thoracic epidural anesthesia

ACTIVE COMPARATOR

Epidural analgesia during midline laparotomy

Drug: Epidural analgesia; Procedure: Laparotomy

Bilateral rectus sheath block

EXPERIMENTAL

Bilateral rectus sheath block during midline laparotomy

Drug: Bilateral rectus sheath block; Procedure: Laparotomy

Interventions

Epidural analgesia DRUG

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.

Thoracic epidural anesthesia

Laparotomy PROCEDURE

A midline sub or supra umbilical laparotomy or xypho-pubian laparotomy

Bilateral rectus sheath block; Thoracic epidural anesthesia

Bilateral rectus sheath block DRUG

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

Bilateral rectus sheath block

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Régional Metz-Thionville: lead

Study Sites (2)

CHR Metz Thionville Hopital de Mercy

Metz, Moselle, 57085, France

RECRUITING

CHR Metz-Thionville Hopital Bel Air

Thionville, 57126, France

NOT YET RECRUITING

Related Publications (1)

• 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 DERIVED

MeSH Terms

Interventions

Analgesia, Epidural; Laparotomy

Intervention Hierarchy (Ancestors)

Analgesia; Anesthesia and Analgesia; Surgical Procedures, Operative

Study Officials

• Antoine BECRET, MD

  CHR Metz Thionville Hopital de Mercy

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Arpiné EL NAR, PhD

CONTACT

0033387557766; arpine.el-nar@chr-metz-thionville.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2021
• First Posted: August 2, 2021
• Study Start: October 11, 2021
• Primary Completion (Estimated): October 10, 2028
• Study Completion (Estimated): April 10, 2029
• Last Updated: December 16, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)