Ultrasound-guided Rectus Sheath Block for Post-operative Pain Control Following Umbilical Hernia Repair

NCT00836134 | Completed DMC

• 1 other identifier: RS_Rectus_sheath
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare the effectiveness of local infiltration to an ultrasound guided nerve block placed by the anesthesiologist for children undergoing umbilical hernia repair. This is a double-cohort, double blinded, randomized study comparing local infiltration to ultrasound-guided rectus sheath block in children 1 to 17 years of age undergoing epigastric or umbilical hernia repair. We will first compare pain scores to see if one method is more adequate then the other in providing post-op analgesia. Our second aim is to compare morphine consumption between the two groups. Our third aim is to measure the levels of local anesthetic in the blood following local anesthetic infiltration or USGRSB.

Conditions

Pain

Keywords

pain relief after umbilical hernia repair; morphine consumption; plasma bupivacaine levels

Outcome Measures

Primary Outcomes (1)

• pain scores

  4 hours

Secondary Outcomes (2)

• morphine consumption

  4 hours

• plasma bupivacaine levels

  0, 10, 20, 30, 45, 60 minutes after injection

Study Arms (2)

1

EXPERIMENTAL

rectus sheath block

Procedure: rectus sheath block

2

ACTIVE COMPARATOR

local anesthetic infiltration

Procedure: local anesthetic infiltration

Interventions

rectus sheath block PROCEDURE

ultrasound-guided rectus sheath block using 0.2ml/kg 0.25% bupivacaine bilaterally prior to skin incision

Also known as: bupivacaine

1

local anesthetic infiltration PROCEDURE

Wound infiltration using 0.4ml/kg 0.25% bupivacaine by the surgeon at the end of surgery

Also known as: bupivacaine

2

Eligibility Criteria

• Age: 1 Year - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children between 1 ≤ 17 years of age
• ASA I (normal healthy children) and II (Children with mild systemic disease that has no functional effects)
• Having elective umbilical hernia repair

You may not qualify if:

• Children \< 1 year of age or \> 17 years of age
• Family has no telephone for follow up phone call
• Allergy or sensitivity to bupivacaine or morphine
• Any coagulation abnormalities
• Emergency surgery

Sponsors & Collaborators

• Seattle Children's Hospital: lead

Study Sites (1)

Seattle Children's Hospital

Seattle, Washington, 98105, United States

Location

MeSH Terms

Conditions

Pain

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Sean H Flack, MBChB FCA

  University of Washington

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 3, 2009
• First Posted: February 4, 2009
• Study Start: February 1, 2009
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: June 12, 2014

Record last verified: 2014-06

Locations

US (1)