Influence of Analgesic Technique on Post Operative Rehabilitation After Median Laparotomy
NCT ID: NCT04985695
Last Updated: 2025-12-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
110 participants
INTERVENTIONAL
2021-10-11
2029-04-10
Brief Summary
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Detailed Description
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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).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Thoracic epidural anesthesia
Epidural analgesia during midline laparotomy
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.
Laparotomy
A midline sub or supra umbilical laparotomy or xypho-pubian laparotomy
Bilateral rectus sheath block
Bilateral rectus sheath block during midline laparotomy
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
Laparotomy
A midline sub or supra umbilical laparotomy or xypho-pubian laparotomy
Interventions
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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
Laparotomy
A midline sub or supra umbilical laparotomy or xypho-pubian laparotomy
Eligibility Criteria
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Inclusion Criteria
* Have given an informed written consent
* Able to read and understand french language
* Affiliation to a social security system
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Centre Hospitalier Régional Metz-Thionville
OTHER
Responsible Party
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Principal Investigators
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Antoine BECRET, MD
Role: PRINCIPAL_INVESTIGATOR
CHR Metz Thionville Hopital de Mercy
Locations
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CHR Metz Thionville Hopital de Mercy
Metz, Moselle, France
CHR Metz-Thionville Hopital Bel Air
Thionville, , France
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Other Identifiers
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2021-01-CHRMT
Identifier Type: -
Identifier Source: org_study_id