PABLO: TAP Block Versus Local Anesthesia Wound Infiltration for Postoperative Pain Relief After Appendicectomy in Children
Study Details
Study Description
Brief Summary
When performing laparoscopic appendectomy in children, regional anesthetic techniques are rou-tinely used concomitantly with general anesthesia. These techniques include local infiltration of the trocar wounds or transverse abdominal plane block (TAP block). In 2018, a position paper of the European Society of Pediatric Anaesthesiology advised for TAP block over local infiltration of the trocar wounds. However, there is no randomized study comparing both techniques in children. The aim of this study is to compare morphine consumption during the first 24 postoperative hours in children undergoing laparoscopic appendectomy and randomly allocated to either local infiltration of the trocar wounds or TAP block.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
This is a double blind randomized study with two parallel groups. Children between 3 and 15 years of age with indication of laparoscopic appendectomy will be approached for inclusion in this trial. Informed consent will be asked for from the parents and the child. Before surgery, patients will be randomized to either local infiltration of the trocar wounds or TAP block using sequentially numbered sealed envelope each with a random number inside. Patients with peritonitis will be excluded. A standardized analgesia protocol within the first 24 post-operative hours will be applied and the primary outcome is nalbuphine consumption during this time frame. Secondary outcomes include postoperative pain (FLACC assessment tool) and postoperative nausea and vomiting.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: TAP Block Transverse abdominal block is realisated at the beginning of the surgery with ultrasound guided technique with levobupivacaine 2.5mg/mL, 0.3mL/kg each side. The patient receives usual analgesia protocol. |
Drug: Levobupivacaine Hydrochloride 2.5 MG/ML
To compare TAP block versus local infiltration of the trocar wounds with levobupivacaine 2.5 mg/ml for post operative pain relief after laparoscopic appendicectomy in children
|
| Active Comparator: local infiltration of the trocar wounds local infiltration of the trocar wounds is realisated at the end of the surgery by the surgeon with levobupivacaine 2.5mg/mL 0.6mL/kg distributed in each trocar opening. The patient receives usual analgesia protocol. |
Drug: Levobupivacaine Hydrochloride 2.5 MG/ML
To compare TAP block versus local infiltration of the trocar wounds with levobupivacaine 2.5 mg/ml for post operative pain relief after laparoscopic appendicectomy in children
|
Outcome Measures
Primary Outcome Measures
- cumulative dose of nalbuphine in the 24 first hours post surgery [24 hours]
recording in mg/kg
Secondary Outcome Measures
- cumulative dose of nalbuphine H0-H12 post surgery [from beginning to 12th hour]
recording in mg/kg
- cumulative dose of nalbuphine H13-H24 post surgery [From 13th hour to 24th hour]
recording in mg/kg
- FLACC analgesia score at H1 H2 H6 H12 H24 [FLACC score will be performed from awakenig to 24 hours post surgery]
Face Leg Activity Cry Consolability heteroevaluation scale from 0 to 10
- FLACC score mean [FLACC score will be performed from awakenig to 24 hours surgery]
Face Leg Activity Cry Consolability heteroevaluation scale from 0 to 10
- individual variations of FLACC score [FLACC score will be performed from awakenig to 24 hours surgery]
Face Leg Activity Cry Consolability heteroevaluation scale from 0 to 10
- timing of first injection of nalbuphine [in the first 24 post operative hours]
recording date and time of first injection
- incidence of post operative nausea and vomiting [in the first 24 post operative hours]
recording the incidence post operative nausea and vomiting
- timing of first standing up [in the first 24 post operative hours]
recording date and time of first standing up
- adverse events [in the first 24 post operative hours]
adverse event monitoring
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Age betwween 3 and 15 years
-
Weight < or = 50 kg
-
indicaction of coelioscopic appendicectomy
-
ASA 1,2 or 3
-
consent of the children and the holder of parental autority
Exclusion Criteria:
-
Age<3 years or > 15years or weight > 50kg
-
refusal of the children and the holder of parental autority
-
ASA 4
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Peritonitis
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Patients with long term morphinic traitment
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Epilepsy
-
Hepato-cellular insuffisiancy
-
local anesthesia allergy or nalbuphine allergy
-
coagulation abnomrmality
-
exclusion of health insurance
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | CHU Besancon | Besançon | France | 25000 |
Sponsors and Collaborators
- Centre Hospitalier Universitaire de Besancon
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2021/571