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The objective of this study is to compare transversus abdominis plane (TAP) blocks to local wound infiltration (LWI) in terms of postoperative pain control in pediatric patients undergoing elective laparoscopic cholecystectomy. Our hypothesis is that TAP blocks will be superior to LWI for postoperative pain control resulting in decreased use of opioid / narcotic pain medication and decreased pain scored in the immediate 24-hour postoperative period. The rationale is that determining the effect of analgesia in this pediatric population is important to optimize clinical care.
In this study, patients ages 8 through 17 years scheduled for elective laparoscopic cholecystectomy will be invited to participate. Those having da Vinci cholecystectomy procedures will also be eligible. The da Vinci System is a minimally invasive option utilizing robotic technology. Once randomized, the patient will undergo either ultrasound guided bilateral TAP blocks or LWI at the beginning of the surgical procedure. Prospective data regarding pain scores, use of opioid medication, and nausea and vomiting episodes will be collected for both groups. Due to the nature of the study, it will not be possible to blind the investigators to the randomly selected method of injecting local anesthesia; however the personnel involved in the post-anesthetic and post-operative assessment will be blinded to the intervention, as well as the subjects themselves.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TAP blocks | Active Comparator | TAP block group will receive three injections performed by an Anesthesiologist trained in the procedure, prior to initiation of the surgical procedure. Bilateral posterior transversalis fascial plane blocks and a right sided subcostal transverse abdominal plane block will be placed under ultrasound guidance. Normal saline will be used to confirm proper muscle layer placement before instillation of the local anesthesia. All patients will receive 2.5 mg/kg or 1 mL/kg of 0.2% ropivacaine with maximum of 60 mL (divided equally amongst the injection sites). |
|
| Local Wound Infiltration | Active Comparator | Local wound infiltration (LWI) will be performed by the operative surgeon using 2.5 mg/kg or 1 mL/kg of 0.2% ropivacaine with maximum of 60 mL divided amongst the four port sites. 40% of the total dose will be given at the umbilicus, and 20% will be given at each of the other 3 ports. The majority of the anesthetic will be administered at the peritoneal level. Laparoscopic/robotic cholecystectomy will be performed with a port at the umbilicus and three smaller ports in a standard fashion in the subxiphoid and right upper quadrant regions. If conversion to open cholecystectomy occurs, the study data will still be collected, but the patient's data will be excluded from analysis. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TAP Blocks | Procedure | ultrasound guided transversus abdominis plane block utilizing 2.5 mg/kg or 1 mL/kg of 0.2% ropivacaine |
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| Measure | Description | Time Frame |
|---|---|---|
| Amount of narcotic pain medication | 24 hours post-op | |
| Time to first request of pain medication | From post-anesthesia care unit "(PACU) in" time to first pain medication dose, up to 24 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gray Brian, MD | Indiana University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Riley Hospital for Children at IU Health | Indianapolis | Indiana | 46202 | United States |
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| ID | Term |
|---|---|
| D009407 | Nerve Block |
| ID | Term |
|---|---|
| D000765 | Anesthesia, Conduction |
| D000758 | Anesthesia |
| D000760 | Anesthesia and Analgesia |
| D003714 | Denervation |
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| local wound infiltration | Procedure | local anesthesia provided at the surgical site utilizing 2.5 mg/kg or 1 mL/kg of 0.2% ropivacaine |
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| D019635 |
| Neurosurgical Procedures |
| D013514 | Surgical Procedures, Operative |