Influence of Analgesic Technique on Post Operative Rehabilitation After Median Laparotomy

Laparotomy Clinical Trial

— QorRecCath  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04985695
• Other study ID #: 2021-01-CHRMT
• Status: Recruiting
• Phase: N/A
• Start date: October 11, 2021
• Est. completion date: April 10, 2026

Study information

• Verified date: November 2023
• Source: Centre Hospitalier Régional Metz-Thionville
• Contact: Arpiné EL NAR, PhD
• Phone: 0033387557766
• Email: arpine.el-nar[@]chr-metz-thionville.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 110
• Est. completion date: April 10, 2026
• Est. primary completion date: October 10, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Laparotomy

Intervention

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.
• 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

Locations

Country	Name	City	State
France	CHR Metz Thionville	Metz	Moselle

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Régional Metz-Thionville

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Postoperative complications link to analgesic technique	Number of postoperative complication in both groups	Postoperative days 1, 2 and 3
Secondary	The length of stay	Comparison of the length of stay between the two groups	Postoperative day 30
Secondary	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
Secondary	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
Secondary	Urinary catheterization	The time during which the patients are taking recourse to postoperative urinary catheterization	Postoperative days 1, 2 and 3
Secondary	Total distance covered	Compare the impact of postoperative analgesia in Walking distance within days following the operation	Postoperative days 1, 2 and 3
Secondary	Failure to set up a catheter	Number of Failure to delivery catheter in both techniques	Postoperative day 1
Secondary	The time until the first raised	Delay before the first raised in hours	Postoperative days 1, 2 and 3