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

Percutaneous Rectus Sheath Block Versus Intra-operative Rectus Sheath Block for Pediatric Umbilical Hernia Repair: A Prospective, Randomized Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02341144
Enrollment
61
Registered
2015-01-19
Start date
2014-12-31
Completion date
2016-04-01
Last updated
2023-07-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain, Postoperative

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.

Interventions

PROCEDUREPre-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.

PROCEDUREIntra-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.

DRUGRopivacaine

Sponsors

Johns Hopkins All Children's Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
3 Years to 18 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Post Operative Pain Ratingfrom entry in post-anesthesia care unit (PACU) until discharge, estimated 1-2 hoursUsing 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

MeasureTime frameDescription
Time to First Narcoticfrom entry in post-anesthesia care unit (PACU) to first narcoticduration until patient received first dose of narcotic in PACU
Pain Score of Zerofrom entry in the post-anesthesia care unit (PACU) until discharge, estimated 1-2 hoursproportion who reported a score of zero throughout their PACU stay using the Wong-Baker (WB) scale with zero being no pain
PACU Morphine Equivalentsfrom entry in post-anesthesia care unit (PACU) until discharge, estimated 1-2 hoursmorphine equivalents received in PACU
PACU Length of Stay (LOS)from entry in post-anesthesia care unit (PACU) until discharge, estimated 1-2 hoursduration of time spent in the post-anesthesia care unit (PACU) from arrival to discharge

Countries

United States

Participant flow

Participants by arm

ArmCount
Pre-op Percutaneous Rectus Sheath Block
ultrasound-guided, percutaneous rectus sheath block by a qualified anesthesiologist 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. Ropivacaine
28
Intra-operative Rectus Sheath Block
rectus sheath block under direct visualization by the attending surgeon 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. Ropivacaine
30
Total58

Baseline characteristics

CharacteristicPre-op Percutaneous Rectus Sheath BlockIntra-operative Rectus Sheath BlockTotal
Age, Continuous6.2 years6.2 years6.2 years
Body mass index (BMI) percentile57 percentile77 percentile61.2 percentile
Sex: Female, Male
Female
16 Participants17 Participants33 Participants
Sex: Female, Male
Male
12 Participants13 Participants25 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 280 / 30
other
Total, other adverse events
0 / 280 / 30
serious
Total, serious adverse events
0 / 280 / 30

Outcome results

Primary

Post Operative Pain Rating

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

Time frame: from entry in post-anesthesia care unit (PACU) until discharge, estimated 1-2 hours

ArmMeasureValue (MEAN)
Pre-op Percutaneous Rectus Sheath BlockPost Operative Pain Rating2.6 units on a scale
Intra-operative Rectus Sheath BlockPost Operative Pain Rating3.3 units on a scale
p-value: 0.11Wilcoxon (Mann-Whitney)
Secondary

PACU Length of Stay (LOS)

duration of time spent in the post-anesthesia care unit (PACU) from arrival to discharge

Time frame: from entry in post-anesthesia care unit (PACU) until discharge, estimated 1-2 hours

ArmMeasureValue (MEDIAN)
Pre-op Percutaneous Rectus Sheath BlockPACU Length of Stay (LOS)76 minutes
Intra-operative Rectus Sheath BlockPACU Length of Stay (LOS)80 minutes
p-value: 0.44Wilcoxon (Mann-Whitney)
Secondary

PACU Morphine Equivalents

morphine equivalents received in PACU

Time frame: from entry in post-anesthesia care unit (PACU) until discharge, estimated 1-2 hours

ArmMeasureValue (MEDIAN)
Pre-op Percutaneous Rectus Sheath BlockPACU Morphine Equivalents0.04 mg/kg
Intra-operative Rectus Sheath BlockPACU Morphine Equivalents0.09 mg/kg
p-value: 0.11Wilcoxon (Mann-Whitney)
Secondary

Pain Score of Zero

proportion who reported a score of zero throughout their PACU stay using the Wong-Baker (WB) scale with zero being no pain

Time frame: from entry in the post-anesthesia care unit (PACU) until discharge, estimated 1-2 hours

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Pre-op Percutaneous Rectus Sheath BlockPain Score of Zero5 Participants
Intra-operative Rectus Sheath BlockPain Score of Zero3 Participants
p-value: 0.39Chi-squared
Secondary

Time to First Narcotic

duration until patient received first dose of narcotic in PACU

Time frame: from entry in post-anesthesia care unit (PACU) to first narcotic

ArmMeasureValue (MEDIAN)
Pre-op Percutaneous Rectus Sheath BlockTime to First Narcotic30 minutes
Intra-operative Rectus Sheath BlockTime to First Narcotic22 minutes
p-value: 0.08Wilcoxon (Mann-Whitney)

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026