A Phase 4 interventional study of Plain bupivacaine and Liposomal bupivacaine in Postoperative Pain, sponsored by University of Texas Southwestern Medical Center. Completed at 1 site in United States. Open to female participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-06-04.
Sponsored by University of Texas Southwestern Medical Center · Phase 4, Interventional, and Prevention
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.
Patients undergoing open total abdominal hysterectomy at Parkland Hospital (n=60) will be randomized into one of two groups to receive either ultrasound-guided bilateral TAP block with bupivacaine (Group 1) or infiltration of the surgical wound with liposomal bupivacaine (Group 2) for postoperative pain management. The remaining aspect of perioperative care, including the general anesthetic technique, postoperative care will be standardized and will be similar for all patients. The duration of the involvement in the study will be until 48 hours postoperatively. The pre-anesthesia care unit personnel will identify patients during their preoperative clinic visit.
Patients in Group 1 will receive ultrasound-guided bilateral TAP block at the end of the surgery. Patients in Group 2 will receive Exparel prior to closing the incision which will be injected subfascially and subcutaneously. In the first 24-h postoperative period, patients in both Groups will receive acetaminophen 1000 mg every 6 h orally, ketorolac 30 mg, IV every 6 h, orally and morphine via an intravenous patient controlled analgesia (IV-PCA) system to maintain adequate pain control. In the 24-48 h study period, all patients will receive oral ibuprofen 800 mg and acetaminophen 1000 mg three times a day and a combination of hydrocodone/acetaminophen 5mg/ 325 mg 1-2 tablets, as needed.
The postoperative analgesia will be documented using the visual analog score (0=no pain, 10=worst pain). In addition, total opioid dose over the 48-h study period will be documented. Postoperative nausea will be measured using a categorical scoring system (none=0, mild=1, moderate=2, severe=3) and episodes of vomiting will be documented. Rescue antiemetics will be given to any patient who complains of nausea and/or vomiting.
All variables will be assessed at 2, 6, 12, 24, and 48 hours, postoperatively by an investigator blinded to group allocation.
5,093 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.
This study's enrollment of 60 is below the median of 75 across 4,344 interventional studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →University of Texas Southwestern Medical Center is the lead sponsor of 990 studies on the registry; 201 are open to participants now.
Of its 135 completed or terminated interventional studies of FDA-regulated products, 100 (74%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
TAP block with plain bupivacaine
Drug: Plain bupivacaine
Wound infiltration with liposomal bupivacaine
Drug: Liposomal bupivacaine
Intraoperative: 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
Also known as: Bupivacaine Hydrochloride
Group 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
Also known as: Exparel
Postoperative Pain Score on Coughing at 6 hr
Visual Analog Pain Scores (VAS); 0 (no pain) to 10 (worst possible pain)
Time frame: Participants' pain score was assessed at 6 hr after surgery
A total of 67 patients were assessed for eligibility and 60 patient enrolled to the study.
| Milestone | TAP Block | Wound Infiltration |
|---|---|---|
| Started | 30 | 30 |
| Completed | 29 | 29 |
| Not completed | 1 | 1 |
Visual Analog Pain Scores (VAS); 0 (no pain) to 10 (worst possible pain)
| units on a scale | TAP Block | Wound Infiltration |
|---|---|---|
| Postoperative Pain Score on Coughing at 6 hr | 5.28 ± 2.45 | 3.59 ± 1.70 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| TAP Block | 0/29 (0%) | 0/29 (0%) | 0/29 (0%) |
| Wound Infiltration | 0/29 (0%) | 0/29 (0%) | 0/29 (0%) |
Patient undergoing hysterectomy
| Age, Continuous(years) | TAP Block | Wound Infiltration | Total |
|---|---|---|---|
| Mean | 43.6 ± 6.4 | 44.4 ± 6.1 | 44 ± 6.2 |
| Sex: Female, Male(Participants) | TAP Block | Wound Infiltration | Total |
|---|---|---|---|
| Female | 29 | 29 | 58 |
| Male | 0 | 0 | 0 |
| Region of Enrollment(participants) | TAP Block | Wound Infiltration | Total |
|---|---|---|---|
| United States | 29 | 29 | 58 |
This study is completed, as verified in May 2018. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of Texas Southwestern Medical Center