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| Name | Class |
|---|---|
| Children's Anesthesiology Associates, Ltd. | OTHER |
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Umbilical hernia repair is a common painful outpatient procedure performed in children. Often analgesia for this procedure is provided by using local infiltration of the surgical site by the surgeons and perioperative opioids and NSAIDS both IV and orally. The use of opioids can cause adverse side effects which include, but are not limited to nausea, vomiting, itching, and respiratory depression, etc. The rectus sheath block can be performed in these patients to decrease their post operative pain.
Umbilical hernia repair, a common Day Surgery procedure in children, is associated with considerable postoperative discomfort. The patient has to meet certain discharge criteria such as tolerating liquids, adequate level of analgesia, etc., prior to being discharged from the day surgery unit.
Currently, both rectus sheath block and local infiltration of the surgical site are used for providing post-operative analgesia for umbilical hernia repair surgery. The local infiltration can only be done at the end of the surgical procedure as it could alter the planes of the surgical field if performed preoperatively. We believe that the analgesia provided prior to the surgical incision will decrease the amount of intraoperative and postoperative opioids used and the subsequent side effects of these medications (5,6). The rectus sheath block, a regional anesthetic technique, offers possible improved pain management following umbilical hernia repair in a recent observational study (1-3,7). We will perform a double-blinded, randomized study to compare the efficacy of rectus sheath block and surgical infiltration in providing postoperative analgesia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | 1) One group will receive the rectus sheath block prior to Umbilical hernia repair. |
|
| 2 | Active Comparator | 2) The second group will receive local anesthetic infiltration of the surgical site at the end the umbilical hernia repair. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bupivacaine | Drug | Bupivacaine, 0.25%, dose amount is weight based, injection is divided per dise with rectus sheath injection or with local infiltration of the operative area. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Amount of Intravenous and Oral Opioids Used by Patients Who Receive a Rectus Sheath Nerve Block and Those Who Receive Local Infiltration of the Surgical Site for Postoperative Analgesia. | total postoperative opioid and any additional analgesic medications. | immediate to 24 hour post-operatively |
| Measure | Description | Time Frame |
|---|---|---|
| The Duration of Analgesia Based on Time to First Rescue Med, the Quality of Analgesia Based on Modified FACES Scale, and the Incidence of Side Effects: Nausea, Vomiting, Pruritus, and Assess Patient Satisfaction With Pain Management. | difference in time to rescue analgesic and the differences in side effects for the two groups. | immediate to 24 hours post-operatively |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Harshad Gurnaney, MBBS | Children's Hospital of Philadelphia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Children's hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | United States |
We screened 120 subjects and excluded 66, 35 patients did not fit the criteria and 31 patients declined to participate. 54 subjects were randomized to receive either a rectus sheath block or local anesthetic infiltration. Two randomized subjects did not get the intervention. 52 subjects did get the intervention - 26 in each arm.
52 patients completed the study, having hernia repair as a day-surgery procedure.
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| ID | Title | Description |
|---|---|---|
| FG000 | Rectus Sheath Block | 1) One group will receive the rectus sheath block prior to Umbilical hernia repair. |
| FG001 | Local Infiltration | 2) The second group will receive local anesthetic infiltration of the surgical site at the end the umbilical hernia repair. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Rectus Sheath Block | 1) One group will receive the rectus sheath block prior to Umbilical hernia repair. |
| BG001 | Local Infiltration | 2) The second group will receive local anesthetic infiltration of the surgical site at the end the umbilical hernia repair. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Amount of Intravenous and Oral Opioids Used by Patients Who Receive a Rectus Sheath Nerve Block and Those Who Receive Local Infiltration of the Surgical Site for Postoperative Analgesia. | total postoperative opioid and any additional analgesic medications. | Posted | Mean | 95% Confidence Interval | mg kg-1 | immediate to 24 hour post-operatively |
|
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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 | Rectus Sheath Block | 1) One group will receive the rectus sheath block prior to Umbilical hernia repair. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| nausea | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Harshad Gurnaney, MBBS, MPH | The Children's Hospital of Philadelphia | 267-426-5850 | gurnaney@email.chop.edu |
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| ID | Term |
|---|---|
| D006554 | Hernia, Umbilical |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006555 | Hernia, Ventral |
| D046449 | Hernia, Abdominal |
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| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Secondary | The Duration of Analgesia Based on Time to First Rescue Med, the Quality of Analgesia Based on Modified FACES Scale, and the Incidence of Side Effects: Nausea, Vomiting, Pruritus, and Assess Patient Satisfaction With Pain Management. | difference in time to rescue analgesic and the differences in side effects for the two groups. | Time to first rescue dose of opioid medication. | Posted | Mean | Standard Deviation | minutes | immediate to 24 hours post-operatively |
|
|
|
| 0 |
| 26 |
| 2 |
| 26 |
| EG001 | Local Infiltration | 2) The second group will receive local anesthetic infiltration of the surgical site at the end the umbilical hernia repair. | 0 | 26 | 1 | 26 |
| vomiting | Gastrointestinal disorders | Systematic Assessment |
|
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| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D000588 |
| Amines |