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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: 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 Summary:

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. Patien
Sponsor: Johns Hopkins All Children's Hospital

Current Primary Outcome: 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: Post Operative Pain Rating [ Time Frame: 5 days ]

using the Wong-Baker FACES Pain Rating Scale (WBFPRS)


Current Secondary Outcome:

  • 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:

  • 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


Information By: Johns Hopkins All Children's Hospital

Dates:
Date Received: December 9, 2014
Date Started: December 2014
Date Completion:
Last Updated: April 13, 2017
Last Verified: April 2017