Postoperative Pain Control in Children Undergoing Laparoscopic Appendectomy: Peripheral Nerve Block Versus Local Anesthetic
Primary Purpose
Postoperative Pain
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Bupivacaine
Bupivacaine
Sponsored by

About this trial
This is an interventional supportive care trial for Postoperative Pain focused on measuring children, laparoscopic appendectomy, iliohypogastric nerve block, rectus sheath nerve block, ilioinguinal nerve block
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
Sites / Locations
- Ann & Robert H Lurie Children's Hospital of Chicago
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Peripheral Nerve Block
local anesthetic infiltration
Arm Description
bilateral rectus sheath and ilioinguinal nerve blocks under ultrasound guidance after induction of general anesthesia administered to subject
local anesthetic infiltration will be administered after induction of general anesthesia
Outcomes
Primary Outcome Measures
Laparoscopic appendectomy infiltration that reduces postoperative pain
Compare postoperative analgesic requirements during the first 48 hours in children undergoing ultrasound-guided (US) rectus sheath and ilioinguinal/iliohypogastric nerve blocks compared with those receiving traditional infiltration of local anesthetic at port sites by the surgeons for laparoscopic appendectomies.
Secondary Outcome Measures
Full Information
NCT ID
NCT01662401
First Posted
July 12, 2012
Last Updated
June 28, 2013
Sponsor
Ann & Robert H Lurie Children's Hospital of Chicago
1. Study Identification
Unique Protocol Identification Number
NCT01662401
Brief Title
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
2. Study Status
Record Verification Date
August 2012
Overall Recruitment Status
Completed
Study Start Date
May 2008 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ann & Robert H Lurie Children's Hospital of Chicago
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
Keywords
children, laparoscopic appendectomy, iliohypogastric nerve block, rectus sheath nerve block, ilioinguinal nerve block
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
66 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Peripheral Nerve Block
Arm Type
Experimental
Arm Description
bilateral rectus sheath and ilioinguinal nerve blocks under ultrasound guidance after induction of general anesthesia administered to subject
Arm Title
local anesthetic infiltration
Arm Type
Experimental
Arm Description
local anesthetic infiltration will be administered after induction of general anesthesia
Intervention Type
Drug
Intervention Name(s)
Bupivacaine
Intervention Description
The volume of 0.25% Bupivacaine at 0.075 ml/kg without epinephrine is 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.
Intervention Type
Drug
Intervention Name(s)
Bupivacaine
Intervention Description
The volume of 0.25% Bupivacaine at 0.075 ml/kg without epinephrine is a maximum of 14 ml.
Primary Outcome Measure Information:
Title
Laparoscopic appendectomy infiltration that reduces postoperative pain
Description
Compare postoperative analgesic requirements during the first 48 hours in children undergoing ultrasound-guided (US) rectus sheath and ilioinguinal/iliohypogastric nerve blocks compared with those receiving traditional infiltration of local anesthetic at port sites by the surgeons for laparoscopic appendectomies.
Time Frame
Participants will be followed for the duration of anesthesia and after surgery, an average of 48 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Ann & Robert H Lurie Children's Hospital of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
8936544
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.
Results Reference
background
PubMed Identifier
16717308
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.
Results Reference
background
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Postoperative Pain Control in Children Undergoing Laparoscopic Appendectomy: Peripheral Nerve Block Versus Local Anesthetic
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