Transversus Abdominis Plane Block vs. Local Wound Infiltration for Elective Laparoscopic Cholecystectomy in Children and Adolescents: A Prospective Randomized-Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Laparoscopic Cholecystectomy
- Sponsor
- Brian Wallace Gray
- Enrollment
- 87
- Locations
- 1
- Primary Endpoint
- Time to first request of pain medication
- Status
- Completed
- Last Updated
- 3 years ago
Overview
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.
Investigators
Brian Wallace Gray
Pediatric surgeon
Indiana University
Eligibility Criteria
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)
Outcomes
Primary Outcomes
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
Amount of narcotic pain medication
Time Frame: 24 hours post-op