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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pre-op percutaneous rectus sheath block | Active Comparator | ultrasound-guided, percutaneous rectus sheath block with ropivacaine by a qualified anesthesiologist |
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| Intra-operative rectus sheath block | Active Comparator | rectus sheath block with ropivacaine under direct visualization by the attending surgeon |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pre-op percutaneous rectus sheath block | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | from entry in post-anesthesia care unit (PACU) until discharge, estimated 1-2 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Time to First Narcotic | duration until patient received first dose of narcotic in PACU | 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" |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nicole M Chandler, MD | Johns Hopkins All Children's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins All Children's Hospital | St. Petersburg | Florida | 33701 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Intra-operative rectus sheath block | Procedure | 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. |
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| Ropivacaine | Drug |
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| from entry in the post-anesthesia care unit (PACU) until discharge, estimated 1-2 hours |
| PACU Morphine Equivalents | morphine equivalents received in PACU | 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 | from entry in post-anesthesia care unit (PACU) until discharge, estimated 1-2 hours |
| FG001 | 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 |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | 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 |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Body mass index (BMI) percentile | body mass index (BMI) percentile: weight (kg) divided by height (m) relative to other children in the US of the same age and sex | Median | Full Range | percentile |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| 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 | Posted | Mean | Full Range | units on a scale | from entry in post-anesthesia care unit (PACU) until discharge, estimated 1-2 hours |
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| Secondary | Time to First Narcotic | duration until patient received first dose of narcotic in PACU | Posted | Median | Full Range | minutes | from entry in post-anesthesia care unit (PACU) to first narcotic |
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| 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" | Posted | Count of Participants | Participants | from entry in the post-anesthesia care unit (PACU) until discharge, estimated 1-2 hours |
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| Secondary | PACU Morphine Equivalents | morphine equivalents received in PACU | Posted | Median | Full Range | mg/kg | from entry in post-anesthesia care unit (PACU) until discharge, estimated 1-2 hours |
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| Secondary | PACU Length of Stay (LOS) | duration of time spent in the post-anesthesia care unit (PACU) from arrival to discharge | Posted | Median | Full Range | minutes | from entry in post-anesthesia care unit (PACU) until discharge, estimated 1-2 hours |
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30 days postoperatively
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 | 0 | 28 | 0 | 28 | 0 | 28 |
| EG001 | 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 | 0 | 30 | 0 | 30 | 0 | 30 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nicole Chandler | Johns Hopkins All Children's Hospital | 7277674170 | 727 | nicole.chandler@jhmi.edu |
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D000077212 | Ropivacaine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
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