The Analgesic Efficacy of M-TAPA for Laparoscopic Abdominal Surgery in Children
ConditionPost Operative Pain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1-7
SponsorKasr El Aini Hospital
About this trial
This investigation aims to assess the efficacy of M-TAPA in children undergoing laparoscopic abdominal surgery.
Sixty pediatric patients undergoing laparoscopic abdominal surgery under general anesthesia will be enrolled in this single-center study. Preoperatively, participants will be randomly assigned to receive either port-site local anesthetic infiltration or M-TAPA.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age (1-7) years.
Both genders.
American Society of Anaesthesiologists (ASA) - physical status I-II.
Children undergoing elective laparoscopic abdominal surgery.
Disqualifiers
Parental refusal.
Bleeding disorders with INR > 1.5 and/or platelets < 50 000.
History of allergic reactions to local anesthetics.
Rash or signs of infection at the injection site.
Trial design
Design model
Parallel
Treatments tested in this trial
port site infiltration
Procedure/Surgerychildren will receive port site LA infiltration.
M-TAPA
Procedure/SurgeryChildren will receive bilateral M-TAPA regional anesthesia block.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: port site infiltrationActive comparator 1 intervention
Group B: M-TAPAActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
FLACC pain score
The FLACC (Face, Leg, Activity, Cry, Consolability) pain score ( Each category is scored on a 0-2 scale, which results in a total score of 0-10 0:comfortable, 1-3: mild discomfort, 4-6: moderate discomfort, \& 7-10: severe discomfort ) (FLACC) scale pain score at 6 hours.
Time frame
6 hours postoperatively.Sponsors and contacts
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Source ClinicalTrials.gov