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Percutaneous Rectus Sheath Block Versus Intra-operative Rectus Sheath Block for Pediatric Umbilical Hernia Repair

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02341144
Recruitment Status : Completed
First Posted : January 19, 2015
Results First Posted : May 16, 2017
Last Update Posted : July 9, 2020
Sponsor:
Information provided by (Responsible Party):
Nicole Chandler, Johns Hopkins All Children's Hospital

Tracking Information
First Submitted Date  ICMJE December 9, 2014
First Posted Date  ICMJE January 19, 2015
Results First Submitted Date  ICMJE March 2, 2017
Results First Posted Date  ICMJE May 16, 2017
Last Update Posted Date July 9, 2020
Study Start Date  ICMJE December 2014
Actual Primary Completion Date March 1, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 13, 2017)
Post Operative Pain Rating [ Time Frame: from entry in post-anesthesia care unit (PACU) until discharge, estimated 1-2 hours ]
Using the Wong-Baker FACES Pain Rating Scale (WBFPRS)- pain scores range from zero (no pain) to ten (worst pain) and the average score was reported
Original Primary Outcome Measures  ICMJE
 (submitted: January 16, 2015)
Post Operative Pain Rating [ Time Frame: 5 days ]
using the Wong-Baker FACES Pain Rating Scale (WBFPRS)
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 13, 2017)
  • Time to First Narcotic [ Time Frame: from entry in post-anesthesia care unit (PACU) to first narcotic ]
    duration until patient received first dose of narcotic in PACU
  • Pain Score of Zero [ Time Frame: from entry in the post-anesthesia care unit (PACU) until discharge, estimated 1-2 hours ]
    proportion who reported a score of zero throughout their PACU stay using the Wong-Baker (WB) scale with zero being "no pain"
  • PACU Morphine Equivalents [ Time Frame: from entry in post-anesthesia care unit (PACU) until discharge, estimated 1-2 hours ]
    morphine equivalents received in PACU
  • PACU Length of Stay (LOS) [ Time Frame: from entry in post-anesthesia care unit (PACU) until discharge, estimated 1-2 hours ]
    duration of time spent in the post-anesthesia care unit (PACU) from arrival to discharge
Original Secondary Outcome Measures  ICMJE
 (submitted: January 16, 2015)
  • Operative time [ Time Frame: 1 day ]
  • Use of post-operative intravenous/oral opioid and non-opioid [ Time Frame: 5 days ]
  • Time to first rescue analgesic [ Time Frame: 1 day ]
  • Side-effects [ Time Frame: 5 days ]
    such as nausea, vomiting, allergic reactions
  • Complications [ Time Frame: 5 days ]
    such as infection, bleeding, intravascular injection, bowel puncture
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Percutaneous Rectus Sheath Block Versus Intra-operative Rectus Sheath Block for Pediatric Umbilical Hernia Repair
Official Title  ICMJE Percutaneous Rectus Sheath Block Versus Intra-operative Rectus Sheath Block for Pediatric Umbilical Hernia Repair: A Prospective, Randomized Study
Brief Summary

This is a prospective, double-blinded, randomized controlled study comparing the efficacy of pre-incisional percutaneous rectus sheath block to intra-operative rectus sheath block under direct visualization prior to closure of the incision for providing post-operative analgesia following umbilical hernia repair in children. The current management for reducible umbilical hernias is umbilical hernia repair under general anesthesia as an outpatient procedure.

Patients aged 3-18 years old with a diagnosis of umbilical hernia will be screened for study inclusion. Eligible patients and their parents/guardians will be approached and, if agreeable, consented for the study pre-operatively. Patients will be randomized to receive either pre-incisional percutaneous rectus sheath block by the anesthesiologist or intra-operative rectus sheath block under direct visualization prior to closure of the skin incision by the surgeon. The patient, patient guardians, select research team members, and post-anesthesia care unit (PACU) staff will be blinded to the method of analgesic administration.

Detailed Description

Regional anesthesia has been increasingly utilized for providing post-operative analgesia for a number of surgical procedures in children. Rectus sheath block and local anesthetic infiltration of the surgical site are two common modes for providing post-operative analgesia following umbilical hernia repair. Studies comparing the two modes have shown ultrasound-guided rectus sheath block to improve immediate pain scores and reduce use of post-operative analgesia in pediatric patients undergoing umbilical hernia repair. However, these studies have compared pre-incisional ultrasound-guided rectus sheath block to post-operative local anesthetic infiltration as a subcutaneous and/or intradermal injection.

The purpose of the investigators' study is to compare the efficacy of pre-incisional percutaneous rectus sheath block to intra-operative rectus sheath block under direct visualization prior to closure of the skin for providing post-operative analgesia following umbilical hernia repair in children.

The investigators propose a prospective study where pediatric patients who are undergoing elective umbilical hernia repair will be randomized pre-operatively to receive either pre-incisional, ultrasound guided percutaneous rectus sheath block or intra-operative rectus sheath block under direct visualization prior to closure of the skin. The primary outcome is the post-operative pain rating based on the Wong-Baker Faces Pain Rating Scale (WBFPRS) following umbilical hernia repair. Additional outcomes measured will include: operative times, the use of intravenous/oral opioid and/or non-opioid medication in the post-operative period, duration of analgesia following surgery based on time to first rescue analgesic, intra-operative hemodynamic changes, post-operative hemodynamic changes, incidence of side-effects, and complications. Patients/patient guardians will receive a sheet to document post-operative WBFPRS scores, oral opioid and non-opioid medication administration once discharged to home for a total of 5 days.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Supportive Care
Condition  ICMJE Pain, Postoperative
Intervention  ICMJE
  • Procedure: Pre-op percutaneous rectus sheath block
    After induction of anesthesia, the attending anesthesiologist will use a portable ultrasound probe to locate the rectus sheath. A 22 gauge needle will be used to inject a predetermined volume of 0.2% ropivacaine (1cc/kg, max dose 10cc, divided into equal doses bilaterally). The analgesic will be injected percutaneously using ultrasound guidance between the rectus abdominis muscle and the posterior rectus sheath at the lateral border bilaterally.
  • Procedure: Intra-operative rectus sheath block
    After the completion of the umbilical hernia repair, after fascial closure, but prior to skin closure, a predetermined volume of 0.2% ropivacaine (1cc/kg, max dose 10c, divided into equal doses bilaterally) will be administered under direct visualization into the rectus sheath bilaterally by the attending surgeon.
  • Drug: Ropivacaine
    Other Name: Naropin
Study Arms  ICMJE
  • Active Comparator: Pre-op percutaneous rectus sheath block
    ultrasound-guided, percutaneous rectus sheath block with ropivacaine by a qualified anesthesiologist
    Interventions:
    • Procedure: Pre-op percutaneous rectus sheath block
    • Drug: Ropivacaine
  • Active Comparator: Intra-operative rectus sheath block
    rectus sheath block with ropivacaine under direct visualization by the attending surgeon
    Interventions:
    • Procedure: Intra-operative rectus sheath block
    • Drug: Ropivacaine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 23, 2017)
61
Original Estimated Enrollment  ICMJE
 (submitted: January 16, 2015)
58
Actual Study Completion Date  ICMJE April 1, 2016
Actual Primary Completion Date March 1, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients aged 3-18 years undergoing elective umbilical hernia repair

Exclusion Criteria:

  • Strangulated or incarcerated umbilical hernia (non-elective)
  • Allergy to bupivacaine/ropivicaine
  • Concurrent surgical procedures
  • Developmental delay or neurologic diagnosis that would interfere with post-operative pain score assessment
  • Chronic pain medication use
  • Chronic pain disorder or complex regional pain syndrome
  • Anesthesiologist classification of III or greater.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 3 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02341144
Other Study ID Numbers  ICMJE IRB00041103
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Nicole Chandler, Johns Hopkins All Children's Hospital
Study Sponsor  ICMJE Johns Hopkins All Children's Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Nicole M Chandler, MD Johns Hopkins All Children's Hospital
PRS Account Johns Hopkins All Children's Hospital
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP