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

NCT ID: NCT03022279

Last Updated: 2023-03-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 87 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-06
• Study Completion Date: 2022-09-30

Brief 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.

Detailed Description

In this study, patients ages 8 through 17 years scheduled for elective laparoscopic cholecystectomy will be invited to participate. Those having da Vinci cholecystectomy procedures will also be eligible. The da Vinci System is a minimally invasive option utilizing robotic technology. Once randomized, the patient will undergo either ultrasound guided bilateral TAP blocks or LWI at the beginning of the surgical procedure. Prospective data regarding pain scores, use of opioid medication, and nausea and vomiting episodes will be collected for both groups. Due to the nature of the study, it will not be possible to blind the investigators to the randomly selected method of injecting local anesthesia; however the personnel involved in the post-anesthetic and post-operative assessment will be blinded to the intervention, as well as the subjects themselves.

Conditions

Laparoscopic Cholecystectomy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

TAP blocks

TAP block group will receive three injections performed by an Anesthesiologist trained in the procedure, prior to initiation of the surgical procedure. Bilateral posterior transversalis fascial plane blocks and a right sided subcostal transverse abdominal plane block will be placed under ultrasound guidance. Normal saline will be used to confirm proper muscle layer placement before instillation of the local anesthesia. All patients will receive 2.5 mg/kg or 1 mL/kg of 0.2% ropivacaine with maximum of 60 mL (divided equally amongst the injection sites).

Group Type: ACTIVE_COMPARATOR

TAP Blocks

Intervention Type: PROCEDURE

ultrasound guided transversus abdominis plane block utilizing 2.5 mg/kg or 1 mL/kg of 0.2% ropivacaine

Local Wound Infiltration

Local wound infiltration (LWI) will be performed by the operative surgeon using 2.5 mg/kg or 1 mL/kg of 0.2% ropivacaine with maximum of 60 mL divided amongst the four port sites. 40% of the total dose will be given at the umbilicus, and 20% will be given at each of the other 3 ports. The majority of the anesthetic will be administered at the peritoneal level. Laparoscopic/robotic cholecystectomy will be performed with a port at the umbilicus and three smaller ports in a standard fashion in the subxiphoid and right upper quadrant regions. If conversion to open cholecystectomy occurs, the study data will still be collected, but the patient's data will be excluded from analysis.

Group Type: ACTIVE_COMPARATOR

local wound infiltration

Intervention Type: PROCEDURE

local anesthesia provided at the surgical site utilizing 2.5 mg/kg or 1 mL/kg of 0.2% ropivacaine

Interventions

TAP Blocks

ultrasound guided transversus abdominis plane block utilizing 2.5 mg/kg or 1 mL/kg of 0.2% ropivacaine

Intervention Type: PROCEDURE

local wound infiltration

local anesthesia provided at the surgical site utilizing 2.5 mg/kg or 1 mL/kg of 0.2% ropivacaine

Intervention Type: PROCEDURE

Other Intervention Names

nerve block; transversus abdominis plane block; local wound injections

Eligibility 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

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Brian Wallace Gray

OTHER

Sponsor Role: lead

Responsible Party

Brian Wallace Gray

Pediatric surgeon

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Gray Brian, MD

Role: PRINCIPAL_INVESTIGATOR

Indiana University

Locations

Riley Hospital for Children at IU Health

Indianapolis, Indiana, United States

Countries

United States

Other Identifiers

1410511719

Identifier Type: -

Identifier Source: org_study_id