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

NCT ID: NCT02400645

Last Updated: 2020-04-28

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 69 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-03-31
• Study Completion Date: 2016-05-31

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.

Conditions

Postoperative Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Group A: pre-incisional bupivacaine

Intervention: Pre-incisional wound infiltration with bupivacaine plain 0.25%. Ketorolac 30mg IV will be given following surgical procedure.

Group Type: ACTIVE_COMPARATOR

Pre-incisional wound infiltration

Intervention Type: PROCEDURE

Intraoperative: Pre-incisional bupivacaine 0.25% up to 20 cc divided dose for trocar incisions

Bupivacaine

Intervention Type: DRUG

20 cc Bupivacaine 0.25% plain will be used for either pre-incisional injection or added to laparoscopic TAP block solution.

Ketorolac

Intervention Type: DRUG

Ketorolac 30mg to be given IV at end of surgical procedure unless contraindicated.

Group B: laparoscope to place TAP block

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 Type: ACTIVE_COMPARATOR

Laparoscope to place TAP block with liposomal bupivacaine

Intervention Type: PROCEDURE

Intraoperative: Laparoscopic TAP block with Liposomal bupivacaine and bupivacaine 0.25%

Liposomal bupivacaine

Intervention Type: DRUG

Use of Liposomal bupivacaine in laparoscopic TAP block

Bupivacaine

Intervention Type: DRUG

20 cc Bupivacaine 0.25% plain will be used for either pre-incisional injection or added to laparoscopic TAP block solution.

Ketorolac

Intervention Type: DRUG

Ketorolac 30mg to be given IV at end of surgical procedure unless contraindicated.

Interventions

Pre-incisional wound infiltration

Intraoperative: Pre-incisional bupivacaine 0.25% up to 20 cc divided dose for trocar incisions

Intervention Type: PROCEDURE

Laparoscope to place TAP block with liposomal bupivacaine

Intraoperative: Laparoscopic TAP block with Liposomal bupivacaine and bupivacaine 0.25%

Intervention Type: PROCEDURE

Liposomal bupivacaine

Use of Liposomal bupivacaine in laparoscopic TAP block

Intervention Type: DRUG

Bupivacaine

20 cc Bupivacaine 0.25% plain will be used for either pre-incisional injection or added to laparoscopic TAP block solution.

Intervention Type: DRUG

Ketorolac

Ketorolac 30mg to be given IV at end of surgical procedure unless contraindicated.

Intervention Type: DRUG

Other Intervention Names

Laparoscopic TAP block with Liposomal bupivacaine; Exparel; Marcaine; Toradol

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Tennessee

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Shanti I Mohling, MD

Role: PRINCIPAL_INVESTIGATOR

University of Tennessee

Other Identifiers

14-132

Identifier Type: -

Identifier Source: org_study_id