NCT01662401

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P25-P50 for phase_2 postoperative-pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2008

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

July 12, 2012

Completed
29 days until next milestone

First Posted

Study publicly available on registry

August 10, 2012

Completed
Last Updated

July 2, 2013

Status Verified

August 1, 2012

Enrollment Period

1.7 years

First QC Date

July 12, 2012

Last Update Submit

June 28, 2013

Conditions

Postoperative Pain

Keywords

childrenlaparoscopic appendectomyiliohypogastric nerve blockrectus sheath nerve blockilioinguinal nerve block

Outcome Measures

Primary Outcomes (1)

  • 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.

    Participants will be followed for the duration of anesthesia and after surgery, an average of 48 hours

Study Arms (2)

Peripheral Nerve Block

EXPERIMENTAL

bilateral rectus sheath and ilioinguinal nerve blocks under ultrasound guidance after induction of general anesthesia administered to subject

Drug: Bupivacaine

local anesthetic infiltration

EXPERIMENTAL

local anesthetic infiltration will be administered after induction of general anesthesia

Drug: Bupivacaine

Interventions

BupivacaineDRUG

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.

Peripheral Nerve Block

Eligibility Criteria

Age6 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ann & Robert H Lurie Children's Hospital of Chicago

Chicago, Illinois, 60611, United States

Location

Related Publications (2)

  • 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.

    PMID: 8936544BACKGROUND

  • 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.

    PMID: 16717308BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 12, 2012

First Posted

August 10, 2012

Study Start

May 1, 2008

Primary Completion

January 1, 2010

Last Updated

July 2, 2013

Record last verified: 2012-08

Locations

US(1)