Efficacy of Transversus Abdominis Plane Block for Laparoscopic Cholecystectomy

• Status: Not yet recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Boston Children's Hospital; Boston Children’s Hospital
• Treatments: Ropivacaine

Criteria

Inclusion Criteria:

1. Patient age 5-17 years old at time of surgery

2. ASA status 1-2

3. Parent is able to provide informed consent and patient's > age 7 able to give assent

4. Patients scheduled for laparoscopic cholecystectomy

5. Surgery will involve and be limited to laparoscopic cholecystectomy

6. Admission status: 24-hour admission to hospital

Exclusion Criteria:

1. Non-English speaking parents/patient.

2. All emergency laparoscopic cholecystectomies or conversion to an open procedure

3. Patients who will remain intubated or require ICU care postoperatively

4. Significant liver or renal disease

5. Coagulopathy

6. Underlying neurocognitive disorder or developmental delay affecting ability to convey feelings of pain to medical staff

7. Diagnosis of chronic pain syndrome

8. Active infection over nerve block sites

9. History of allergy to local anesthetic agents or non-steroidal anti-inflammatory drugs (NSAIDS)

10. Known alcohol or substance abuse within the past 6 months

11. Daily Opioid use

12. ASA class 3 or higher