Clinical trial NCT02400645: TAP Block With Liposomal Bupivacaine Versus Pre-incisional Wound Infiltration With Bupivacaine for Postoperative Pain
Official title: Comparison of Laparoscopically Assisted Transversus Abdominis Plane Block Using Liposomal Bupivacaine With Pre-incisional Bupivacaine for Post-operative Pain Control in Patients Undergoing Laparoscopic or Robotic Hysterectomy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Postoperative Pain
Keywords: laparoscopic hysterectomy
robotic assisted hysterectomy
Lead sponsor: University of Tennessee
Sponsor class: OTHER
First posted: 2015-03-27
Enrollment: 69
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: In this randomized, controlled, double-blinded trial we plan to evaluate post-operative pain relief after laparoscopic-assisted Transversus Abdominis Plane (TAP) block using liposomal bupivacaine plus bupivacaine versus pre-incisional would infiltration with bupivacaine in patients undergoing Total laparoscopic or robotic assisted laparoscopic hysterectomy.

Detailed description: Patients undergoing laparoscopic or robotic assisted total hysterectomy at Erlanger Hospital will be randomized into one of two groups to receive either laparoscopic assisted TAP block with liposomal bupivacaine and bupivacaine (Group A) or pre-incisional bupivacaine (Group B). The remaining aspects of the perioperative care, including the general anesthesia care and postoperative care will be similar for all patients. Ideally, patients will be informed and consented for the study in the preoperative clinic setting. They will be randomized in the pre-anesthesia care unit.

Patients in Group A will receive laparoscopic-assisted bilateral TAP blocks using 10cc liposomal bupivacaine, 10cc Bupivacaine 0.25% and 10cc Normal Saline one each side. Patients in Group B will receive a total of 20cc pre-incisional Bupivacaine divided between each of the trocar sites. All patients will receive Ketorolac 30 mg, IV at the conclusion of surgery. All patients will be offered either oral pain medications or patient controlled anesthesia (PCA) opiate pain medication as indicated. Morphine equivalents will be calculated.

Postoperative pain control will be assessed using Visual Analog Pain Score (VAS). This will be done by recovery room personnel who will be blinded as to whether the patients received TAP block or pre-incisional anesthetic. VAS will be assessed at rest at 1 hour and 2 hours after arrival to PACU. Patients will be assessed with Overall Benefit of Anesthesia Score (OBAS) questionnaires at postoperative days 1, 2 and 7. OBAS questionnaires will be done by personnel blinded to anesthesia technique. Patients will also be blinded as to which group they were in. Total morphine equivalents of intraoperative and postoperative pain medications will be calculated through postoperative day 7.

Eligibility criteria: Inclusion Criteria:

* ASA physical status 1-3,
* Scheduled for laparoscopic or robotic assisted laparoscopic hysterectomy,
* Able to participate personally or by legal representation in informed consent

Exclusion Criteria:

* History of relevant allergy to the study drugs (Bupivacaine),
* Chronic opioid use or drug abuse history,
* Inability to understand the study protocol,
* Refusal to provide written consent,
* Soft tissue infection of the abdominal wall and skin

Primary outcomes:
measure: Visual Analog pain scores (VAS)
timeFrame: Two hours
Secondary outcomes:
measure: Narcotic pain medication usage
timeFrame: 2 hours postoperative
measure: Narcotic pain medication following surgery
timeFrame: 1 week
Other outcomes:
measure: Overall Benefit of Anesthesia scores (OBAS) on postoperative days 1,2 and 7
timeFrame: One week
Locations:
Study officials:
affiliation: University of Tennessee
name: Shanti I Mohling, MD
role: PRINCIPAL_INVESTIGATOR
References: