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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04985695
Other study ID # 2021-01-CHRMT
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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