Clinical trial NCT03022279: Nerve Blocks vs Local Injections for Post-op Pain Prevention in Laparoscopic Cholecystectomy in Children
Official title: Transversus Abdominis Plane Block vs. Local Wound Infiltration for Elective Laparoscopic Cholecystectomy in Children and Adolescents: A Prospective Randomized-Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Laparoscopic Cholecystectomy
Keywords: Pediatric
post-operative pain prevention
Anesthesia, Infiltration
Nerve Blockade
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2017-01-16
Enrollment: 87
Sex: ALL
Minimum age (years): 8
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Amount of narcotic pain medication
timeFrame: 24 hours post-op
measure: Time to first request of pain medication
timeFrame: From post-anesthesia care unit "(PACU) in" time to first pain medication dose, up to 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Riley Hospital for Children at IU Health
state: Indiana
Study officials:
affiliation: Indiana University
name: Gray Brian, MD
role: PRINCIPAL_INVESTIGATOR
References: