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

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ClinicalTrials.gov Identifier: NCT02341144
Recruitment Status : Completed
First Posted : January 19, 2015
Results First Posted : May 16, 2017
Last Update Posted : May 16, 2017
Sponsor:
Information provided by (Responsible Party):
Nicole Chandler, Johns Hopkins All Children's Hospital

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.


Condition or disease Intervention/treatment Phase
Pain, Postoperative Procedure: Pre-op percutaneous rectus sheath block Procedure: Intra-operative rectus sheath block Drug: Ropivacaine Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 61 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Percutaneous Rectus Sheath Block Versus Intra-operative Rectus Sheath Block for Pediatric Umbilical Hernia Repair: A Prospective, Randomized Study
Study Start Date : December 2014
Actual Primary Completion Date : March 1, 2016
Actual Study Completion Date : April 1, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia

Arm Intervention/treatment
Active Comparator: Pre-op percutaneous rectus sheath block
ultrasound-guided, percutaneous rectus sheath block with ropivacaine by a qualified anesthesiologist
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.

Drug: Ropivacaine
Other Name: Naropin

Active Comparator: Intra-operative rectus sheath block
rectus sheath block with ropivacaine under direct visualization by the attending surgeon
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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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"

  3. PACU Morphine Equivalents [ Time Frame: from entry in post-anesthesia care unit (PACU) until discharge, estimated 1-2 hours ]
    morphine equivalents received in PACU

  4. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02341144


Locations
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United States, Florida
Johns Hopkins All Children's Hospital
Saint Petersburg, Florida, United States, 33701
Sponsors and Collaborators
Johns Hopkins All Children's Hospital
Investigators
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Principal Investigator: Nicole M Chandler, MD Johns Hopkins All Children's Hospital

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Responsible Party: Nicole Chandler, Assistant Professor of Surgery, Johns Hopkins All Children's Hospital
ClinicalTrials.gov Identifier: NCT02341144     History of Changes
Other Study ID Numbers: 41103
First Posted: January 19, 2015    Key Record Dates
Results First Posted: May 16, 2017
Last Update Posted: May 16, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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