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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sean Flack, Seattle Children's Hospital
ClinicalTrials.gov Identifier:
NCT00836134
First received: February 3, 2009
Last updated: June 10, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention
Pain
Procedure: rectus sheath block
Procedure: local anesthetic infiltration

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Ultrasound-guided Rectus Sheath Block for Post-operative Pain Control Following Umbilical Hernia Repair

Resource links provided by NLM:


Further study details as provided by Seattle Children's Hospital:

Primary Outcome Measures:
  • pain scores [ Time Frame: 4 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • morphine consumption [ Time Frame: 4 hours ] [ Designated as safety issue: No ]
  • plasma bupivacaine levels [ Time Frame: 0, 10, 20, 30, 45, 60 minutes after injection ] [ Designated as safety issue: Yes ]

Enrollment: 40
Study Start Date: February 2009
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
rectus sheath block
Procedure: rectus sheath block
ultrasound-guided rectus sheath block using 0.2ml/kg 0.25% bupivacaine bilaterally prior to skin incision
Other Name: bupivacaine
Active Comparator: 2
local anesthetic infiltration
Procedure: local anesthetic infiltration
Wound infiltration using 0.4ml/kg 0.25% bupivacaine by the surgeon at the end of surgery
Other Name: bupivacaine

Detailed Description:

Healthy children, aged 1 to 17 years of age, undergoing elective umbilical hernia repairs will be considered for this study. After informed consent/assent has been obtained, the subject will be randomized into one of two groups. Group A will receive local infiltration of 0.25% bupivacaine by the surgeon at the end of the subject's surgery. Group B will undergo an ultrasound-guided rectus sheath block using 0.25% bupivacaine prior to incision by an anesthesiologist skilled in the performance of this block.

All subjects will receive a standardized anesthetic for their surgery. Subjects assigned to Group A (local infiltration) will receive 2mcg/kg of fentanyl prior to incision for intra-operative pain management. Subjects assigned to Group B will have their Rectus Sheath Block and no fentanyl will be given at this time.

Fentanyl is a short-acting opioid analgesic. It's duration of action in the dose we will be using is approximately one hour which is close to the expected length of surgery. Therefore, it is not expected to influence the pain management after surgery.

Pain scores will be assessed by a member of the research team. They will be blinded to which technique the subject has been randomized to. This person will not be involved in the direct care of the subject. These observations will be made using an age-appropriate scoring system (FLACC or FACES scale). Scoring will be done every 5 minutes when the subject is in the recovery room and every 30 minutes when they are in Phase II. This will be done until the subject is discharged from the hospital.

Families will be followed by phone for 48 h post discharge, to collect data on medication use.

  Eligibility

Ages Eligible for Study:   1 Year to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00836134

Locations
United States, Washington
Seattle Children's Hospital
Seattle, Washington, United States, 98105
Sponsors and Collaborators
Seattle Children's Hospital
Investigators
Principal Investigator: Sean H Flack, MBChB FCA University of Washington
  More Information

No publications provided

Responsible Party: Sean Flack, Principal Investigator, Seattle Children's Hospital
ClinicalTrials.gov Identifier: NCT00836134     History of Changes
Other Study ID Numbers: RS_Rectus_sheath
Study First Received: February 3, 2009
Last Updated: June 10, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Seattle Children's Hospital:
pain relief after umbilical hernia repair
morphine consumption
plasma bupivacaine levels

Additional relevant MeSH terms:
Hernia
Hernia, Umbilical
Pain, Postoperative
Pathological Conditions, Anatomical
Infant, Newborn, Diseases
Hernia, Ventral
Hernia, Abdominal
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Anesthetics, Local
Bupivacaine
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 22, 2014