Pain, PostoperativeNCT02341144
Percutaneous Rectus Sheath Block Versus Intra-operative Rectus Sheath Block for Pediatric Umbilical Hernia Repair
A study testing Pre-op percutaneous rectus sheath block, Intra-operative rectus sheath block and Ropivacaine in people with Pain, Postoperative, run by Johns Hopkins All Children's Hospital at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 3 to 18 years
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- Pre-op percutaneous rectus sheath block, Intra-operative rectus sheath block and Ropivacaine
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2014to 1 Apr 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients aged 3-18 years undergoing elective umbilical hernia repair
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins All Children's Hospital
St. Petersburg, Florida, 33701
About this study
Official title: 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 post-anesthesia care unit (PACU) staff will be blinded to the method of analgesic administration.
Read the 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.
- Conditions
- Pain, Postoperative
- Being tested
- Pre-op percutaneous rectus sheath block, Intra-operative rectus sheath block, Ropivacaine
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pre-op percutaneous rectus sheath blockProcedure or surgery
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.
Intra-operative rectus sheath blockProcedure or surgery
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.
RopivacaineDrug
Also called Naropin
| Study group | Role | What they receive |
|---|---|---|
| Pre-op percutaneous rectus sheath block | Active comparator | ultrasound-guided, percutaneous rectus sheath block with ropivacaine by a qualified anesthesiologist Receives: Procedure: Pre-op percutaneous rectus sheath block; Drug: Ropivacaine |
| Intra-operative rectus sheath block | Active comparator | rectus sheath block with ropivacaine under direct visualization by the attending surgeon Receives: Procedure: Intra-operative rectus sheath block; Drug: Ropivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: from entry in post-anesthesia care unit (PACU) until discharge, estimated 1-2 hours
Secondary outcomes (4)
Time to First Narcotic
duration until patient received first dose of narcotic in PACU
Measured: from entry in post-anesthesia care unit (PACU) to first narcotic
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"
Measured: from entry in the post-anesthesia care unit (PACU) until discharge, estimated 1-2 hours
PACU Morphine Equivalents
morphine equivalents received in PACU
Measured: from entry in post-anesthesia care unit (PACU) until discharge, estimated 1-2 hours
PACU Length of Stay (LOS)
duration of time spent in the post-anesthesia care unit (PACU) from arrival to discharge
Measured: from entry in post-anesthesia care unit (PACU) until discharge, estimated 1-2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2015 (estimated)
- Study startDec 2014
- Primary completion1 Mar 2016
- Study completion1 Apr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins All Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicole M Chandler, MD, Principal investigator, Johns Hopkins All Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02341144
- Sponsor's protocol ID
- IRB00041103
- Status last verified
- Jun 2023
- First submitted
- 9 Dec 2014
- Last updated
- 3 Jul 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Percutaneous Rectus Sheath Block Versus Intra-operative Rectus Sheath Block for Pediatric Umbilical Hernia Repair: A Prospective, Randomized Study
- ClinicalTrials.gov ID
- NCT02341144
- Acronym / sponsor ID
- IRB00041103
- Conditions
- Pain, Postoperative
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Johns Hopkins All Children's HospitalUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- 1 Mar 2016 (actual)
- Study completion
- 1 Apr 2016 (actual)
- First posted
- 19 Jan 2015 (estimated)
- Results
- Posted 16 May 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pre-op percutaneous rectus sheath block | Active comparator | Procedure: Pre-op percutaneous rectus sheath block, Drug: Ropivacaineultrasound-guided, percutaneous rectus sheath block with ropivacaine by a qualified anesthesiologist |
| Intra-operative rectus sheath block | Active comparator | Procedure: Intra-operative rectus sheath block, Drug: Ropivacainerectus sheath block with ropivacaine under direct visualization by the attending surgeon |
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Patients aged 3-18 years undergoing elective umbilical hernia repair
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pre-op percutaneous rectus sheath blockAfter 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 or surgery | Pre-op percutaneous rectus sheath block |
| Intra-operative rectus sheath blockAfter 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. | Procedure or surgery | Intra-operative rectus sheath block |
| RopivacaineAlso: Naropin | Drug | Intra-operative rectus sheath block, Pre-op percutaneous rectus sheath block |
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
4 secondary outcomes
Time to First Narcotic
Time frame: from entry in post-anesthesia care unit (PACU) to first narcotic
Pain Score of Zero
Time frame: from entry in the post-anesthesia care unit (PACU) until discharge, estimated 1-2 hours
PACU Morphine Equivalents
Time frame: from entry in post-anesthesia care unit (PACU) until discharge, estimated 1-2 hours
PACU Length of Stay (LOS)
Time frame: from entry in post-anesthesia care unit (PACU) until discharge, estimated 1-2 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicole M Chandler, MD principal investigator
Johns Hopkins All Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pre-op percutaneous rectus sheath block, Intra-operative rectus sheath block and Ropivacaine in people with Pain, Postoperative, run by Johns Hopkins All Children's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 May 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post Operative Pain Rating (time frame: from entry in post-anesthesia care unit (PACU) until discharge, estimated 1-2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2023.