Percutaneous Rectus Sheath Block Versus Intra-operative Rectus Sheath Block for Pediatric Umbilical Hernia Repair
| Status: | Completed |
|---|---|
| Conditions: | Post-Surgical Pain |
| Therapuetic Areas: | Musculoskeletal |
| Healthy: | No |
| Age Range: | 3 - 18 |
| Updated: | 1/25/2017 |
| Start Date: | December 2014 |
| End Date: | April 1, 2016 |
Percutaneous Rectus Sheath Block Versus Intra-operative Rectus Sheath Block for Pediatric Umbilical Hernia Repair: A Prospective, Randomized Study
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
PACU staff will be blinded to the method of analgesic administration.
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
PACU staff will be blinded to the method of analgesic administration.
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.
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.
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.
We found this trial at
1
site
Saint Petersburg, Florida 33701
Principal Investigator: Nicole M Chandler, MD
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