TAP Block With Liposomal Bupivacaine Versus Pre-incisional Wound Infiltration With Bupivacaine for Postoperative Pain

Phase 1

Terminated

• Conditions: Postoperative Pain
• Interventions: Procedure: Pre-incisional wound infiltration; Procedure: Laparoscope to place TAP block with liposomal bupivacaine; Drug: Bupivacaine; Drug: Liposomal bupivacaine; Drug: Ketorolac

• Registration Number: NCT02400645
• Lead Sponsor: University of Tennessee

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.

Study Timeline

• Status Verified: 2015-03
• Study Start: 2015-03
• Study First Submitted: 2015-03-11
• Study First Submitted QC: 2015-03-26
• Study First Posted: 2015-03-27
• Primary Completion: 2016-05
• Study Completion: 2016-05
• Last Update Submitted: 2020-04-27
• Last Update Posted: 2020-04-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 69

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A: pre-incisional bupivacaine	Pre-incisional wound infiltration	Intervention: Pre-incisional wound infiltration with bupivacaine plain 0.25%. Ketorolac 30mg IV will be given following surgical procedure.
Group A: pre-incisional bupivacaine	Bupivacaine	Intervention: Pre-incisional wound infiltration with bupivacaine plain 0.25%. Ketorolac 30mg IV will be given following surgical procedure.
Group B: laparoscope to place TAP block	Laparoscope to place TAP block with liposomal bupivacaine	Intervention: laparoscope to place TAP block with liposomal bupivacaine and bupivacaine plain 0.25%. Ketorolac 30 mg IV will be given following surgical procedure.
Group B: laparoscope to place TAP block	Bupivacaine	Intervention: laparoscope to place TAP block with liposomal bupivacaine and bupivacaine plain 0.25%. Ketorolac 30 mg IV will be given following surgical procedure.
Group B: laparoscope to place TAP block	Liposomal bupivacaine	Intervention: laparoscope to place TAP block with liposomal bupivacaine and bupivacaine plain 0.25%. Ketorolac 30 mg IV will be given following surgical procedure.
Group A: pre-incisional bupivacaine	Ketorolac	Intervention: Pre-incisional wound infiltration with bupivacaine plain 0.25%. Ketorolac 30mg IV will be given following surgical procedure.
Group B: laparoscope to place TAP block	Ketorolac	Intervention: laparoscope to place TAP block with liposomal bupivacaine and bupivacaine plain 0.25%. Ketorolac 30 mg IV will be given following surgical procedure.

Primary Outcome Measures

Name	Time	Method
Visual Analog pain scores (VAS)	Two hours	1. Postoperative pain at 1 hour and 2 hours after arrival to recovery using Visual Analog Pain Scores (VAS); 2. VAS: 0 (no pain) TO 10 (worst possible pain)

Secondary Outcome Measures

Name	Time	Method
Narcotic pain medication usage	2 hours postoperative	Narcotic pain medication usage intraoperative and in recovery assessed as morphine equivalents
Narcotic pain medication following surgery	1 week	Narcotic pain medication pill counts up to one week postoperatively