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

Laparoscopic Cholecystectomy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03022279
• Other study ID #: 1410511719
• Status: Completed
• Phase: N/A
• Start date: January 6, 2017
• Est. completion date: September 2022

Study information

• Verified date: March 2023
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 87
• Est. completion date: September 2022
• Est. primary completion date: September 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Laparoscopic Cholecystectomy

Intervention

Procedure:
• TAP Blocks
ultrasound guided transversus abdominis plane block utilizing 2.5 mg/kg or 1 mL/kg of 0.2% ropivacaine
• local wound infiltration
local anesthesia provided at the surgical site utilizing 2.5 mg/kg or 1 mL/kg of 0.2% ropivacaine

Locations

Country	Name	City	State
United States	Riley Hospital for Children at IU Health	Indianapolis	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Brian Wallace Gray

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Amount of narcotic pain medication		24 hours post-op
Primary	Time to first request of pain medication		From post-anesthesia care unit "(PACU) in" time to first pain medication dose, up to 24 hours