Postoperative Pain | TAP Block With Plain Bupivacaine Versus Wound Infiltration With Exparel for Postoperative Pain Management
Postoperative Pain research study
What is the primary objective of this study?
In this randomized, controlled, observer-blinded study we plan to evaluate pain relief after ultrasound-guided transversus abdominis plane (TAP) block using bupivacaine and wound infiltration using liposomal bupivacaine in patients undergoing abdominal hysterectomy.
Who is eligible to participate?
Inclusion Criteria: - Female - ASA physical status 1-3 - Scheduled for open abdominal hysterectomy - Age 18-80 years old - Able to participate personally or by legal representative in informed consent in English or Spanish Exclusion Criteria: - History of relevant drug allergy - Age less than 18 or greater than 80 years - Chronic opioid use or drug abuse - Significant psychiatric disturbance - Inability to understand the study protocol - Refusal to provide written consent
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:Plain bupivacaineIntraoperative: TAP block with plain bupivacaine + Acetaminophen 1000 mg IV + Ketorolac 30 mg IV . First 24-h Postoperative: Ketorolac 30 mg, IV 3 more doses, + acetaminophen 1000 mg 3 more doses, + IV-PCA morphine. 24-48-h Postoperative: Oral ibuprofen 800 mg q 8 h + hydrocodone/acetaminophen 5mg/500 mg 1-2 tablets q 6h,prn
Drug:Liposomal bupivacaineGroup intraoperative: Wound infiltration with liposomal bupivacaine (Exparel) + IV acetaminophen 1000 mg IV + Ketorolac 30 mg IV First 24-h Postoperative: Ketorolac 30 mg, IV 3 more doses, + acetaminophen 1000 mg 3 more doses, + IV-PCA morphine 24-48-h Postoperative: Oral ibuprofen 800 mg q 8 h + hydrocodone/acetaminophen 5mg/500 mg 1-2 tablets q 6h, prn
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
TAP blockTAP block with plain bupivacaine
Wound infiltrationWound infiltration with liposomal bupivacaine
Start Date: January 2014
Completed Date: February 2015
Phase: Phase 4
Primary Outcome: Postoperative Pain Score on Coughing at 6 hr
Study sponsors, principal investigator, and references
Principal Investigator: Irina Gasanova, MD., PhD.
Lead Sponsor: University of Texas Southwestern Medical Center