Transversus abdominis plane (TAP) block with bupivacaine versus wound infiltration with liposomal bupivacaine (Exparel) for postoperative pain management after open total abdominal hysterectomy: a prospective randomized controlled trial

Study ID
STU 072013-080

Cancer Related
No

Healthy Volunteers
No

Study Sites

Contact
Emine Babar Melik
214-590-8081
emine.babarmelik@utsouthwestern.edu

Principal Investigator
Irina Gasanova

Summary

Patients undergoing open total abdominal hysterectomy (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 duration of the involvement in the study will be until 48 hours postoperatively. 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/375 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.
Bilateral TaP block will be performed by anesthesiologists with previous experience of the ultrasound-guided technique using the SonoSite M-Turbo and linear 6-13 MHz transducer. exparel wound infiltration will be performed by surgeons using the same technique surgeons already use to infiltrate local anesthetics. 25 gauge needle will be used for infiltration. one vial of 1.3% of 20 ml exparel (266 mg) will be diluted with 20 ml of normal saline to total volume of 40 ml which is enough volume to cover the area. 20 ml will be infiltrated in fanlike fashion on each side of the incision above and below the fascia, 20 ml will be infiltrated into the deep subcutaneous tissue.
a standard postoperative analgesic regimen for the first 24-h postoperative period in both groups will include ketorolac 30 mg administered at the end of surgery followed by ketorolac 30 mg, iV every 6 h. in addition, patients will receive acetaminophen 1000 mg, orally every 6 hours. For breakthrough pain (or rescue), morphine iV-PCa will be provided (with PCa setting of 1 mg every 10 min and a 4-h lockout of 40 mg. 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/375 mg 1-2 tablets, prn.
The efficacy of postoperative analgesia will be documented in all patients using the visual analog score (0[?]no pain, 10[?]worst pain). in addition, total morphine 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 or vomiting. all variables will be assessed at 2, 6, 12, 24,and 48 hours postoperatively by an investigator blinded to group allocation.


Participant Eligibility

-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