Influence of Analgesic Technique on Post Operative Rehabilitation After Median Laparotomy (QorRecCath)

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

Randomized controlled trial (1:1) in two parallel groups, monocentric, 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.

Study Overview

• Status: Recruiting
• Conditions: Laparotomy
• Intervention / Treatment: Drug: Epidural analgesia; Procedure: Laparotomy; Drug: Bilateral rectus sheath block

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).

• Study Type: Interventional
• Enrollment (Estimated): 110
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Arpiné EL NAR, PhD; Phone Number: 0033387557766; Email: arpine.el-nar@chr-metz-thionville.fr

Study Locations

• France
  • Moselle
    • Metz, Moselle, France, 57085
      • Recruiting
      • CHR Metz Thionville
      • Contact: Antoine BECRET, MD; Phone Number: 0033 387553069; Email: antoine.becret@chr-metz-thionville.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Thoracic epidural anesthesia; Epidural analgesia during midline laparotomy	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.; Procedure: Laparotomy; A midline sub or supra umbilical laparotomy or xypho-pubian laparotomy
Experimental: Bilateral rectus sheath block; Bilateral rectus sheath block during midline laparotomy	Procedure: Laparotomy; A midline sub or supra umbilical laparotomy or xypho-pubian laparotomy; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy of postoperative analgesia	The efficacy of postoperative analgesia was compared between the two groups with the visual analog scale (VAS). The VAS intensity rating consisted of a 100-mm line with the end points no pain (0 mm) and worst pain (100 mm). Study participants were asked to evaluated with a mark on the line their current pain intensity. The difference between each postoperative treatment VAS score was compared.	Postoperative days 1, 2, 3 and 30
Impact of arterial hypotension	The impact of arterial hypotension was compared between the two groups with the arterial pressure value before and after laparotomy	Postoperative days 1, 2 and 3
Impact of orthostatic hypotension	The impact of orthostatic hypotension was compared between the two groups with the arterial pressure value before and after surgery.	Postoperative days 1, 2 and 3
Occurrence of nausea and/or vomiting	The effect of analgesic technique on nausea and/or vomiting is calculated on the basis of the number of anti-vomiting prescribed.	Postoperative days 1, 2 and 3
Postoperative complications link to analgesic technique	Number of postoperative complication in both groups	Postoperative days 1, 2 and 3
The length of stay	Comparison of the length of stay between the two groups	Postoperative day 30
Return to normal bowel function	Delay in hours to promotes normal digestive activity. The included the times to recovery the first bowel sounds, first anal exhaust and defecation.	Postoperative days 1, 2 and 3
The quantity of morphine or equivalent	The quantity of morphine or equivalent administered during the 48 first hours in both groups	Postoperative days 1 and 2
Urinary catheterization	The time during which the patients are taking recourse to postoperative urinary catheterization	Postoperative days 1, 2 and 3
Total distance covered	Compare the impact of postoperative analgesia in Walking distance within days following the operation	Postoperative days 1, 2 and 3
Failure to set up a catheter	Number of Failure to delivery catheter in both techniques	Postoperative day 1
The time until the first raised	Delay before the first raised in hours	Postoperative days 1, 2 and 3

Collaborators and Investigators

• Sponsor: Centre Hospitalier Régional Metz-Thionville
• Investigators: Principal Investigator: Antoine BECRET, MD, CHR Metz Thionville Hopital de Mercy

Study record dates

Study Major Dates

• Study Start (Actual): October 11, 2021
• Primary Completion (Estimated): October 10, 2025
• Study Completion (Estimated): April 10, 2026

Study Registration Dates

• First Submitted: July 8, 2021
• First Submitted That Met QC Criteria: July 21, 2021
• First Posted (Actual): August 2, 2021

Study Record Updates

• Last Update Posted (Actual): December 26, 2023
• Last Update Submitted That Met QC Criteria: December 20, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: postoperative rehabilitation
• Other Study ID Numbers: 2021-01-CHRMT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: According to the French law and the French Data Protection Authority (CNIL), we won't be able to publicly share individual participant data, but we plan to share their conclusions through peer-reviewed publications and conferences.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No