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

B

Brian Wallace Gray

Status

Completed

Conditions

Laparoscopic Cholecystectomy

Treatments

Procedure: TAP Blocks
Procedure: local wound infiltration

Study type

Interventional

Funder types

Other

Identifiers

NCT03022279
1410511719

Details and patient eligibility

About

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.

Full 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.

Enrollment

87 patients

Sex

All

Ages

8 to 17 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

87 participants in 2 patient groups

TAP blocks
Active Comparator group
Description:
TAP block group will receive three injections performed by an Anesthesiologist trained in the procedure, prior to initiation of the surgical procedure. Bilateral posterior transversalis fascial plane blocks and a right sided subcostal transverse abdominal plane block will be placed under ultrasound guidance. Normal saline will be used to confirm proper muscle layer placement before instillation of the local anesthesia. All patients will receive 2.5 mg/kg or 1 mL/kg of 0.2% ropivacaine with maximum of 60 mL (divided equally amongst the injection sites).
Treatment:
Procedure: TAP Blocks
Local Wound Infiltration
Active Comparator group
Description:
Local wound infiltration (LWI) will be performed by the operative surgeon using 2.5 mg/kg or 1 mL/kg of 0.2% ropivacaine with maximum of 60 mL divided amongst the four port sites. 40% of the total dose will be given at the umbilicus, and 20% will be given at each of the other 3 ports. The majority of the anesthetic will be administered at the peritoneal level. Laparoscopic/robotic cholecystectomy will be performed with a port at the umbilicus and three smaller ports in a standard fashion in the subxiphoid and right upper quadrant regions. If conversion to open cholecystectomy occurs, the study data will still be collected, but the patient's data will be excluded from analysis.
Treatment:
Procedure: local wound infiltration

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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