Analgesic Efficacy After Umbilical Hernia Repair in Children
Recruitment status was Active, not recruiting
| Tracking Information | |||||
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| First Received Date ICMJE | December 18, 2007 | ||||
| Last Updated Date | February 14, 2011 | ||||
| Start Date ICMJE | November 2006 | ||||
| Primary Completion Date | December 2009 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
To compare the amount of intravenous and oral opioids used by patients between the patients who receive a rectus sheath nerve block and those who receive local infiltration of the surgical site for postoperative analgesia. [ Time Frame: immediate to 24 hour post-operatively ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00578136 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
To determine the duration of analgesia based on time to first rescue med, the quality of analgesia based on modified FACES scale, the incidence of side effects: Nausea, Vomiting, Pruritus, and assess patient satisfaction with pain management. [ Time Frame: immediate to 24 hours post-operatively ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Analgesic Efficacy After Umbilical Hernia Repair in Children | ||||
| Official Title ICMJE | A Randomized-Double Blinded Trial Comparing the Analgesic Efficacy and Side Effects of Rectus Sheath Block vs. Infiltration of Surgical Site for Post Operative Pain Control After Umbilical Hernia Repair Surgery | ||||
| Brief Summary | 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. |
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| Detailed Description | 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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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
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| Condition ICMJE | Umbilical Hernia | ||||
| Intervention ICMJE | Drug: Bupivacaine
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. |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Estimated Enrollment ICMJE | 90 | ||||
| Estimated Completion Date | December 2011 | ||||
| Primary Completion Date | December 2009 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 5 Years to 17 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00578136 | ||||
| Other Study ID Numbers ICMJE | 2006-10-4980 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Harshad Gurnaney, MD, The Children's Hospital of Philadelphia | ||||
| Study Sponsor ICMJE | Children's Hospital of Philadelphia | ||||
| Collaborators ICMJE | Children's Anesthesiology Associates, Ltd. | ||||
| Investigators ICMJE |
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| Information Provided By | Children's Hospital of Philadelphia | ||||
| Verification Date | February 2011 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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