Clinical trial NCT01662401: Postoperative Pain Control in Children Undergoing Laparoscopic Appendectomy: Peripheral Nerve Block Versus Local Anesthetic
Official title: Postoperative Pain Control in Children Undergoing Laparoscopic Appendectomy: Comparison of Peripheral Nerve Blocks to Local Anesthetic
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Postoperative Pain
Keywords: children
laparoscopic appendectomy
iliohypogastric nerve block
rectus sheath nerve block
ilioinguinal nerve block
Lead sponsor: Ann & Robert H Lurie Children's Hospital of Chicago
Sponsor class: OTHER
First posted: 2012-08-10
Enrollment: 66
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: After undergoing a laparoscopic appendectomy, a child may experience some degree of pain in the postoperative period. As a routine part of the procedure, surgeons inject local anesthetic where the laparoscopic ports are placed. This provides some pain relief, but most children will still require additional pain medications after surgery. The purpose of the study is to see if a combination of peripheral nerve blocks (rectus sheath and ilioinguinal nerve) will give better pain relief, decreasing pain medication requirements and increasing comfort during the postoperative period.

Detailed description: A study investigator who is not involved in the immediate care of the patient will use a computer generated randomized table as to whether a child undergoing laparoscopic appendectomy will receive local anesthetic infiltration to the laparoscopic port placement sites by the surgeon, or peripheral nerve blocks by the anesthesiologist. All subjects will receive a dose of fentanyl at 2 mcg/kg with a maximum dose of 100 mcg. If the subject is to get peripheral nerve blocks, the anesthesiologist will administer bilateral rectus sheath and ilioinguinal nerve blocks under ultrasound guidance after induction of general anesthesia. The local anesthetic used will be 0.25% bupivacaine without epinephrine for both local infiltration and peripheral nerve blocks. It has been shown that a dose of 0.075 ml/kg is the minimum amount of local anesthetic needed for a successful block. This will be the dose for each block with a maximum of 3 ml for rectus sheath blocks, and 4 ml for ilioinguinal blocks adding up to a total maximum dose of 14 ml of 0.25% bupivacaine. The infiltration of port sites by surgeons will also be limited to a total of 14 ml. If a subject does not have adequate analgesia in the post anesthesia care unit (PACU), they may receive morphine 0.05 mg/kg (max 2 mg) per dose; some may receive a dose of ketorolac 0.5 mg/kg (max 30 mg) per surgeon preference. A blinded observer will observe the subject for pain in the PACU using a validated pain scale, Faces Pain Scale - Revised (FPS-R). The need for additional pain medications will be noted by an observer in the PACU and followed for the first 24 hours postoperatively. All data will be entered in an Excel spreadsheet and the number of doses of rescue analgesics used will be used as the parameter to judge the efficacy of the peripheral nerve blocks versus local anesthetic infiltration.

Eligibility criteria: Inclusion Criteria:

* All children scheduled for laparoscopic appendectomy between the ages of 6 and 18
* Written informed consent from parent of guardian

Exclusion Criteria:

* Sensitivities to local anesthetics
* Significant renal, liver, or cardiac disease
* Appendectomy requiring an open procedure

Primary outcomes:
measure: Laparoscopic appendectomy infiltration that reduces postoperative pain
timeFrame: Participants will be followed for the duration of anesthesia and after surgery, an average of 48 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Ann & Robert H Lurie Children's Hospital of Chicago
state: Illinois
Study officials:
References:
citation: Ferguson S, Thomas V, Lewis I. The rectus sheath block in paediatric anaesthesia: new indications for an old technique? Paediatr Anaesth. 1996;6(6):463-6. doi: 10.1046/j.1460-9592.1996.d01-24.x.
citation: Willschke H, Bosenberg A, Marhofer P, Johnston S, Kettner S, Eichenberger U, Wanzel O, Kapral S. Ultrasonographic-guided ilioinguinal/iliohypogastric nerve block in pediatric anesthesia: what is the optimal volume? Anesth Analg. 2006 Jun;102(6):1680-4. doi: 10.1213/01.ane.0000217196.34354.5a.