Riley Hospital for Children at IU Health
Indianapolis, Indiana, 46202, United States
NCT Number: NCT03022279
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.
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Notify Me8 year–17 year
All sexes
Interventional
Not applicable
Indianapolis, Indiana, 46202, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
ultrasound guided transversus abdominis plane block utilizing 2.5 mg/kg or 1 mL/kg of 0.2% ropivacaine
Other names: nerve block, transversus abdominis plane block
local anesthesia provided at the surgical site utilizing 2.5 mg/kg or 1 mL/kg of 0.2% ropivacaine
Other names: local wound injections
Time frame: 24 hours post-op
Time frame: From post-anesthesia care unit "(PACU) in" time to first pain medication dose, up to 24 hours
Brian Wallace Gray
Other
Transversus Abdominis Plane Block vs. Local Wound Infiltration for Elective Laparoscopic Cholecystectomy in Children and Adolescents: A Prospective Randomized-Controlled Trial
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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