Clinical trial NCT04985695: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Laparotomy
Keywords: postoperative rehabilitation
Lead sponsor: Centre Hospitalier Régional Metz-Thionville
Sponsor class: OTHER
First posted: 2021-08-02
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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).

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

Primary outcomes:
measure: Change in total QoR-15 score
timeFrame: Postoperative day 2
Secondary outcomes:
measure: Change in total Qor-15 score on postoperative days 1 and 3 compared to the day before surgery
timeFrame: Postoperative days 1, and 3
measure: Efficacy of postoperative analgesia
timeFrame: Day 0 and Postoperative days 1, 2, 3 and 30
measure: Impact of arterial hypotension
timeFrame: Postoperative days 1, 2 and 3
measure: Impact of orthostatic hypotension
timeFrame: Postoperative days 1, 2 and 3
measure: Occurrence of nausea and/or vomiting
timeFrame: Day 0, Postoperative days 1, 2 and 3 and at hospital discharge up to 30 days
measure: Postoperative complications link to analgesic technique
timeFrame: Postoperative days 1, 2 and 3
measure: The length of stay
timeFrame: at hospital discharge up to 30 days
measure: Return to normal bowel function
timeFrame: Postoperative days 1, 2 and 3 and at hospital discharge up to 30 days
measure: The quantity of morphine or equivalent
timeFrame: Day 0 and Postoperative days 1, 2 and 3
measure: Urinary catheterization
timeFrame: at hospital discharge up to 30 days
measure: Total distance covered
timeFrame: Postoperative days 1, 2 and 3
measure: Failure to set up a catheter
timeFrame: Postoperative day 1
measure: The time until the first raised
timeFrame: Postoperative days 1, 2 and 3 and at hospital discharge up to 30 days
measure: Impact of premature discontinuation of local anesthetic perfusion
timeFrame: on day 0
measure: Patient satisfaction and need for further consultation
timeFrame: at hospital discharge up to 30 days and on postoperative day 30
Other outcomes:
Locations:
city: Metz
country: France
facility: CHR Metz Thionville Hopital de Mercy
state: Moselle
city: Thionville
country: France
facility: CHR Metz-Thionville Hopital Bel Air
Study officials:
affiliation: CHR Metz Thionville Hopital de Mercy
name: Antoine BECRET, MD
role: PRINCIPAL_INVESTIGATOR
References: