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Completed

NCT Number: NCT03022279

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

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.

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Key information

Age range

8 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Riley Hospital for Children at IU Health

Indianapolis, Indiana, 46202, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 8-17 yrs of age at date of enrollment.
  • Elective laparoscopic or da Vinci cholecystectomy scheduled for any diagnostic reason.

Exclusion criteria

  • 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
  • Children in custody of the state
  • Subjects will a BMI >/= 50
  • Investigator discretion for any other reason

Treatment and study plan

TAP Blocks

Procedure

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

Other names: nerve block, transversus abdominis plane block

Local wound infiltration

Procedure

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

Other names: local wound injections

Primary outcomes

  1. Amount of narcotic pain medication

    Time frame: 24 hours post-op

  2. Time to first request of pain medication

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

Sponsors and collaborators

Lead sponsor

Brian Wallace Gray

Other

Registry information

Official study title

Transversus Abdominis Plane Block vs. Local Wound Infiltration for Elective Laparoscopic Cholecystectomy in Children and Adolescents: A Prospective Randomized-Controlled Trial

Important dates

Study start
2017
Primary completion
2022
Study completion
2022
First posted
Jan 16, 2017
Registry last updated
Mar 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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