Anesthesia, Recovery Period Clinical Trial
Official title:
Transversus Abdominis Plane Block Versus Caudal Epidural for Lower Abdominal Surgery in Children: A Double-Blinded Randomized Controlled Trial
| Verified date | June 2014 |
| Source | Nemours Children's Clinic |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Institutional Review Board |
| Study type | Interventional |
Transversus abdominis plane block (TAPB) has emerged as a safe and effective regional anesthesia technique for providing postoperative lower abdominal analgesia. Complications associated with TAPB are very rare and pose a lower overall risk to the patient receiving a TAPB versus a caudal block, which is considered the gold standard for pediatric lower abdominal regional anesthesia. Our study hypothesis was that TAPB would be equivalent to caudal block initially in providing postoperative pain control but would show improved pain relief beyond the anticipated caudal duration.
| Status | Completed |
| Enrollment | 45 |
| Est. completion date | May 2014 |
| Est. primary completion date | December 2013 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 1 Year to 9 Years |
| Eligibility |
Inclusion Criteria: - Patients aged 1 to 9 years old scheduled for intravesicular ureteral reimplantation surgery Exclusion Criteria: 1. Coagulation status or anatomic variations precluded safe placement of either TAPB or caudal epidural, 2. there was a preexisting chronic pain disorder, 3. there was a history of constipation that persisted despite appropriate treatment and that may have impacted postoperative pain assessments, 4. additional procedures were planned via a separate incision at the time of the ureteral reimplantation, 5) there was a contraindication to receiving the medications described in the protocol. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Supportive Care
| Country | Name | City | State |
|---|---|---|---|
| United States | Wolfson Children's Hospital, Baptist Medical Center- Downtown, 800 Prudential Drive | Jacksonville | Florida |
| Lead Sponsor | Collaborator |
|---|---|
| Nemours Children's Clinic |
United States,
Tripi PA, Palmer JS, Thomas S, Elder JS. Clonidine increases duration of bupivacaine caudal analgesia for ureteroneocystostomy: a double-blind prospective trial. J Urol. 2005 Sep;174(3):1081-3. — View Citation
Vetter TR, Carvallo D, Johnson JL, Mazurek MS, Presson RG Jr. A comparison of single-dose caudal clonidine, morphine, or hydromorphone combined with ropivacaine in pediatric patients undergoing ureteral reimplantation. Anesth Analg. 2007 Jun;104(6):1356-63, table of contents. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Narcotic requirement | Narcotic requirement was recorded at 24 hours from the time of the block placement. | 24 hours post intervention | No |
| Secondary | episodes of nausea/vomiting | Episodes of nausea/vomiting were recorded at 24 hours from the time of the block placement. | 24 hours | No |
| Secondary | anti-spasmodic requirement | Anti-spasmodic requirement were recorded at 24 hours from the time of the block placement. | 24 hours post intervention | No |
| Secondary | Pain Scores | Pain scores (FLACC/FACES) were recorded at 24 hours from the time of the block placement | 24 hours post intervention | No |