Efficacy of Transversus Abdominis Plane Block for Laparoscopic Cholecystectomy
Status:
Not yet recruiting
Trial end date:
2022-12-01
Target enrollment:
Participant gender:
Summary
Laparoscopic cholecystectomy is associated with considerable postoperative pain and
surgeon-administered local anesthetic infiltration is the standard practice for achieving
post-operative analgesia. However, recent studies have shown that pediatric patients continue
to experience significant pain during the first 24 hours.
The investigators plan to conduct a prospective, double-blinded, randomized study where
patients will be designated into either a test group receiving an ultrasound-guided
transversus abdominis plane (TAP) and rectus sheath (RS) blocks with ropivacaine and
peri-portal sterile saline or the control group that will receive ultrasound-guided TAP block
with sterile saline and peri-portal infiltration of ropivacaine. The anesthesia team and
surgical team will both be blinded as well as the research personal in the postoperative
period. Patients age 5-17 and American Society of Anesthesiology status I and II undergoing
laparoscopic cholecystectomy will be included.
The study hypothesis is that ultrasound-guided peripheral nerve blocks, specifically single
shot transversus abdominis plane and rectus sheath blocks, are superior to local wound
infiltration during laparoscopic cholecystectomy for decreasing postoperative pain and pain
related behavior and facilitating functional recovery.
Phase:
Phase 3
Details
Lead Sponsor:
Boston Children's Hospital Boston Children’s Hospital