Influence of Analgesic Technique on Post Operative Rehabilitation After Median Laparotomy
- Conditions
- Laparotomy
- Interventions
- Drug: Epidural analgesiaDrug: Bilateral rectus sheath blockProcedure: Laparotomy
- Registration Number
- NCT04985695
- Lead Sponsor
- Centre Hospitalier RĂ©gional Metz-Thionville
- 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).
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 110
- 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
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Thoracic epidural anesthesia Epidural analgesia Epidural analgesia during midline laparotomy Thoracic epidural anesthesia Laparotomy Epidural analgesia during midline laparotomy Bilateral rectus sheath block Bilateral rectus sheath block Bilateral rectus sheath block during midline laparotomy Bilateral rectus sheath block Laparotomy Bilateral rectus sheath block during midline laparotomy
- Primary Outcome Measures
Name Time Method Change in total QoR-15 score Postoperative day 2 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).
- Secondary Outcome Measures
Name Time Method Change in total Qor-15 score on postoperative days 1 and 3 compared to the day before surgery Postoperative days 1, and 3 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).
Efficacy of postoperative analgesia Day 0 and Postoperative days 1, 2, 3 and 30 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.
Impact of arterial hypotension Postoperative days 1, 2 and 3 The impact of arterial hypotension was compared between the two groups with the arterial pressure value before and after laparotomy
Impact of orthostatic hypotension Postoperative days 1, 2 and 3 The impact of orthostatic hypotension was compared between the two groups with the arterial pressure value before and after surgery.
Occurrence of nausea and/or vomiting Day 0, Postoperative days 1, 2 and 3 and at hospital discharge up to 30 days The effect of analgesic technique on nausea and/or vomiting is calculated on the basis of the number of anti-vomiting prescribed.
Postoperative complications link to analgesic technique Postoperative days 1, 2 and 3 Number of postoperative complication in both groups
The length of stay at hospital discharge up to 30 days Comparison of the length of stay between the two groups
Return to normal bowel function Postoperative days 1, 2 and 3 and at hospital discharge up to 30 days Delay in hours to promotes normal digestive activity. The included the times to recovery the first bowel sounds, first anal exhaust and defecation.
The quantity of morphine or equivalent Day 0 and Postoperative days 1, 2 and 3 The quantity of morphine or equivalent administered during the 48 first hours in both groups
Urinary catheterization at hospital discharge up to 30 days The time during which the patients are taking recourse to postoperative urinary catheterization
Total distance covered Postoperative days 1, 2 and 3 Compare the impact of postoperative analgesia in Walking distance (meter) within days following the operation
Failure to set up a catheter Postoperative day 1 Number of Failure to delivery catheter in both techniques
The time until the first raised Postoperative days 1, 2 and 3 and at hospital discharge up to 30 days Delay before the first raised in hours
Impact of premature discontinuation of local anesthetic perfusion on day 0 Number of premature discontinuation of local anesthetics
Patient satisfaction and need for further consultation at hospital discharge up to 30 days and on postoperative day 30 Satisfaction questionnaire
Trial Locations
- Locations (2)
CHR Metz Thionville Hopital de Mercy
đŸ‡«đŸ‡·Metz, Moselle, France
CHR Metz-Thionville Hopital Bel Air
đŸ‡«đŸ‡·Thionville, France