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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Thoracic epidural anesthesia | Active Comparator | Epidural analgesia during midline laparotomy |
|
| Bilateral rectus sheath block | Experimental | Bilateral rectus sheath block during midline laparotomy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Epidural analgesia | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in total Qor-15 score on postoperative days 1 and 3 compared to the day before surgery | 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Arpiné EL NAR, PhD | Contact | 0033387557766 | arpine.el-nar@chr-metz-thionville.fr |
| Name | Affiliation | Role |
|---|---|---|
| Antoine BECRET, MD | CHR Metz Thionville Hopital de Mercy | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHR Metz Thionville Hopital de Mercy | Recruiting | Metz | Moselle | 57085 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37221022 | Derived | 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. |
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According to the French law and the French Data Protection Authority (CNIL), we won't be able to publicly share individual participant data, but we plan to share their conclusions through peer-reviewed publications and conferences.
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| ID | Term |
|---|---|
| D015360 | Analgesia, Epidural |
| D007813 | Laparotomy |
| ID | Term |
|---|---|
| D000698 | Analgesia |
| D000760 | Anesthesia and Analgesia |
| D013514 | Surgical Procedures, Operative |
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| Bilateral rectus sheath block | Drug | 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 | Procedure | A midline sub or supra umbilical laparotomy or xypho-pubian laparotomy |
|
| Postoperative days 1, and 3 |
| 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. | Day 0 and Postoperative days 1, 2, 3 and 30 |
| 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 |
| 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 |
| 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. | Day 0, Postoperative days 1, 2 and 3 and at hospital discharge up to 30 days |
| Postoperative complications link to analgesic technique | Number of postoperative complication in both groups | Postoperative days 1, 2 and 3 |
| The length of stay | Comparison of the length of stay between the two groups | at hospital discharge up to 30 days |
| 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 and at hospital discharge up to 30 days |
| The quantity of morphine or equivalent | The quantity of morphine or equivalent administered during the 48 first hours in both groups | Day 0 and Postoperative days 1, 2 and 3 |
| Urinary catheterization | The time during which the patients are taking recourse to postoperative urinary catheterization | at hospital discharge up to 30 days |
| Total distance covered | Compare the impact of postoperative analgesia in Walking distance (meter) within days following the operation | Postoperative days 1, 2 and 3 |
| Failure to set up a catheter | Number of Failure to delivery catheter in both techniques | Postoperative day 1 |
| The time until the first raised | Delay before the first raised in hours | Postoperative days 1, 2 and 3 and at hospital discharge up to 30 days |
| Impact of premature discontinuation of local anesthetic perfusion | Number of premature discontinuation of local anesthetics | on day 0 |
| Patient satisfaction and need for further consultation | Satisfaction questionnaire | at hospital discharge up to 30 days and on postoperative day 30 |
| CHR Metz-Thionville Hopital Bel Air | Not yet recruiting | Thionville | 57126 | France |
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