Henry Ford Hospital
Detroit, Michigan, 48202, United States
NCT Number: NCT03250507
The goal of this study is to evaluate the effectiveness of different formulations of bupivacaine infiltrated into the transversus abdominis plane (TAP) on post-operative pain management after open abdominal hysterectomy.
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Notify Me18 year and older
Female
Interventional
Phase 4
Detroit, Michigan, 48202, United States
All eligible patients who consent to the study will be randomized to one of three groups. Group 1 will receive a TAP block with 60 mL 0.25% bupivacaine. Group 2 will receive a TAP block with 20 mL liposomal bupivacaine and 40 mL saline. Group 3 will receive a TAP block with 20 mL liposomal bupivacaine and 40 mL 0.25% bupivacaine. Patients will be assessed in the post-anesthesia care unit (PACU) at once each on Post-operative day 1,2, and 3.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
0.25% bupivacaine for TAP block
Other names: Marcaine, Sensorcaine
Exparel for TAP block
Other names: Exparel
Saline for TAP block that will be mixed with liposomal bupivacaine to bring the liposomal bupivacaine group to 60 mL total volume.
Time frame: 0 - 72 hours post-operatively
Total opioid consumption
Time frame: 0 - 72 hours post-operatively
time to first opioid given
Time frame: 0 - 72 hours post-operatively
Patient satisfaction post-operatively. The number of patients who were very satisfied is reported.
Time frame: until the patient is discharged from the hospital
Length of stay in the hospital, maximum time until discharge from the hospital
Time frame: 0 - 72 hours post-operatively
Presence of local anesthetic toxicity
Time frame: 0 - 72 hours post-operatively
Presence of hemodynamic instability
Time frame: 0-24 postoperative pain scores
Maximum pain score 0 - 24 hr. Pain scores are reported on a scale of 0-10. 0 = no pain, 1-3 = mild pain, 4-6 = moderate pain, and 7-10 = severe pain.
Henry Ford Health System
Other
Mixture of Liposomal Bupivicaine and Bupivicaine Hydrogen Chloride (HCl) May Provide Faster and Longer Lasting Analgesia in Transversus Abdominis Block for Patient Having Open Abdominal Hysterectomies
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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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