Postoperative Pain
Conditions
Keywords
Pain, Liposomal bupivacaine, Wound infiltration
Brief summary
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.
Detailed description
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.
Interventions
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
DRUGLiposomal bupivacaine
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
Sponsors
University of Texas Southwestern Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 80 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Pain Score on Coughing at 6 hr | Participants' pain score was assessed at 6 hr after surgery | Visual Analog Pain Scores (VAS); 0 (no pain) to 10 (worst possible pain) |
Countries
United States
Participant flow
Recruitment details
A total of 67 patients were assessed for eligibility and 60 patient enrolled to the study.
Participants by arm
| Arm | Count |
|---|---|
| TAP Block TAP block with plain bupivacaine | 29 |
| Wound Infiltration Wound infiltration with liposomal bupivacaine | 29 |
| Total | 58 |
Baseline characteristics
| Characteristic | TAP Block | Wound Infiltration | Total |
|---|---|---|---|
| Age, Continuous | 43.6 years STANDARD_DEVIATION 6.4 | 44.4 years STANDARD_DEVIATION 6.1 | 44 years STANDARD_DEVIATION 6.2 |
| Region of Enrollment United States | 29 participants | 29 participants | 58 participants |
| Sex: Female, Male Female | 29 Participants | 29 Participants | 58 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 29 | 0 / 29 |
| other Total, other adverse events | 0 / 29 | 0 / 29 |
| serious Total, serious adverse events | 0 / 29 | 0 / 29 |
Outcome results
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TAP Block | Postoperative Pain Score on Coughing at 6 hr | 5.28 units on a scale | Standard Deviation 2.45 |
| Wound Infiltration | Postoperative Pain Score on Coughing at 6 hr | 3.59 units on a scale | Standard Deviation 1.7 |