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

N
Nicole Horn, MD

Primary Investigator

B
Brian Gray, MD

Primary Investigator

Enrolling By Invitation
8 years - 17 years
All
Phase N/A
1 Location

Brief description of study

This study investigates pain control methods for children and adolescents undergoing elective laparoscopic cholecystectomy, which is a surgery to remove the gallbladder. The study will compare two methods: the transversus abdominis plane (TAP) block and local wound infiltration (LWI). Both methods utilize the same numbing medication. A TAP block involves injections given near specific nerves to block sensations of pain from a targeted area of the body, specifically helping to lessen feelings of pain around the belly. Local wound infiltration involves injecting anesthetic directly into the incision site, similar to how a dentist may numb your gums.

Participants will be randomly assigned to receive either a TAP block or local wound infiltration during their surgery. The study will measure and compare the effectiveness of these two methods in managing postoperative pain. Additionally, it will examine differences in the amount of pain medication requested post-surgery, the duration of hospital stay, pain scores in the recovery area, and the timing of initial pain medication requirement during the postoperative period. By doing so, the study aims to understand which method provides better pain relief for young patients undergoing this type of surgery.

Detailed description of study

  • Who can participate: Children and adolescents aged 8 to 18 years who are scheduled to undergo elective laparoscopic cholecystectomy can participate in this study.
  • Study details: Participants will be divided into two arms: one receiving a TAP block and the other receiving local wound infiltration during surgery. The study will observe and compare pain levels after surgery in both groups.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: laparoscopic cholecystectomy
  • Age: 8 years - 17 years
  • Gender: All

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

 

Updated on 29 Jan 2015. Study ID: ANES-IIR-HORN-TAPVLWI, 1410511719
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Interested in the study?

This study is accepting only persons who receive care at a certain clinic or doctor or who are part of an invited group. Questions about this study can be directed to the study team listed in the description or contact your doctor to see if you are eligible.

Accepting referrals by invitation only