Overview

Nerve Blocks vs Local Injections for Post-op Pain Prevention in Laparoscopic Cholecystectomy in Children

Status:
Enrolling by invitation
Trial end date:
2023-01-01
Target enrollment:
0
Participant gender:
All
Summary
The objective of this study is to compare transversus abdominis plane (TAP) blocks to local wound infiltration (LWI) in terms of postoperative pain control in pediatric patients undergoing elective laparoscopic cholecystectomy. Our hypothesis is that TAP blocks will be superior to LWI for postoperative pain control resulting in decreased use of opioid / narcotic pain medication and decreased pain scored in the immediate 24-hour postoperative period. The rationale is that determining the effect of analgesia in this pediatric population is important to optimize clinical care.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Brian Wallace Gray
Nicole Horn
Treatments:
Ropivacaine
Criteria
Inclusion Criteria:

1. 8-17 yrs of age at date of enrollment.

2. Elective laparoscopic or da Vinci cholecystectomy scheduled for any diagnostic reason.

Exclusion Criteria:

1. Chronic pain or chronic use of narcotic or other prescription pain medications.

2. Use of pain medication within 24 hours before surgery

3. Prior major abdominal surgery

4. Evidence of acute inflammation

5. Patients with acute cholecystitis

6. Bleeding / coagulation disorder

7. Seizure disorder

8. Renal dysfunction

9. Infection at injection sites for TAP block or trocar placement

10. Contraindication to LWI or TAP block procedure, as determined by surgeon or
anesthesiologist performing the procedure (including, but not limited to, previous
incision distorting anatomy or inability to visualize anatomical planes)

11. Any known allergy to medications used in this study

12. Patient unable to verbalize pain score or independently assess pain level

13. Unstable patient in need of emergent intervention at surgeon discretion

14. Patients who are known to be pregnant

15. Patients who are currently prisoners

16. Children in custody of the state

17. Subjects will a BMI >/= 50

18. Investigator discretion for any other reason