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

NCT03022279 | Completed DMC

• 1 other identifier: 1410511719
• Study Type: interventional
• Target: 87
• Locations: 1 country
• Sites: 1

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.

Conditions

Laparoscopic Cholecystectomy

Keywords

Pediatric; post-operative pain prevention; Anesthesia, Infiltration; Nerve Blockade

Outcome Measures

Primary Outcomes (2)

• Amount of narcotic pain medication

  24 hours post-op

• Time to first request of pain medication

  From post-anesthesia care unit "(PACU) in" time to first pain medication dose, up to 24 hours

Study Arms (2)

TAP blocks

ACTIVE COMPARATOR

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).

Procedure: TAP Blocks

Local Wound Infiltration

ACTIVE COMPARATOR

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.

Procedure: local wound infiltration

Interventions

TAP Blocks PROCEDURE

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

Also known as: nerve block, transversus abdominis plane block

TAP blocks

local wound infiltration PROCEDURE

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

Also known as: local wound injections

Local Wound Infiltration

Eligibility Criteria

• Age: 8 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• yrs of age at date of enrollment.
• Elective laparoscopic or da Vinci cholecystectomy scheduled for any diagnostic reason.

You may not qualify if:

• Chronic pain or chronic use of narcotic or other prescription pain medications.
• Use of pain medication within 24 hours before surgery
• Prior major abdominal surgery
• Evidence of acute inflammation
• Patients with acute cholecystitis
• Bleeding / coagulation disorder
• Seizure disorder
• Renal dysfunction
• Infection at injection sites for TAP block or trocar placement
• 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)
• Any known allergy to medications used in this study
• Patient unable to verbalize pain score or independently assess pain level
• Unstable patient in need of emergent intervention at surgeon discretion
• Patients who are known to be pregnant
• Patients who are currently prisoners

Sponsors & Collaborators

• Brian Wallace Gray: lead

Study Sites (1)

Riley Hospital for Children at IU Health

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Interventions

Nerve Block

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia; Denervation; Neurosurgical Procedures; Surgical Procedures, Operative

Study Officials

• Gray Brian, MD

  Indiana University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Pediatric surgeon

Study Record Dates

• First Submitted: November 25, 2016
• First Posted: January 16, 2017
• Study Start: January 6, 2017
• Primary Completion: September 1, 2022
• Study Completion: September 1, 2022
• Last Updated: March 3, 2023

Record last verified: 2023-03

Locations

US (1)