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

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

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.

Study Overview

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

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 Type: Interventional
• Enrollment (Actual): 69
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group A: pre-incisional bupivacaine; Intervention: Pre-incisional wound infiltration with bupivacaine plain 0.25%. Ketorolac 30mg IV will be given following surgical procedure.	Procedure: Pre-incisional wound infiltration; Intraoperative: Pre-incisional bupivacaine 0.25% up to 20 cc divided dose for trocar incisions; Drug: Bupivacaine; 20 cc Bupivacaine 0.25% plain will be used for either pre-incisional injection or added to laparoscopic TAP block solution.; Other Names: Marcaine; Drug: Ketorolac; Ketorolac 30mg to be given IV at end of surgical procedure unless contraindicated.; Other Names: Toradol
Active Comparator: 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.	Drug: Bupivacaine; 20 cc Bupivacaine 0.25% plain will be used for either pre-incisional injection or added to laparoscopic TAP block solution.; Other Names: Marcaine; Drug: Ketorolac; Ketorolac 30mg to be given IV at end of surgical procedure unless contraindicated.; Other Names: Toradol; Procedure: Laparoscope to place TAP block with liposomal bupivacaine; Intraoperative: Laparoscopic TAP block with Liposomal bupivacaine and bupivacaine 0.25%; Other Names: Laparoscopic TAP block with Liposomal bupivacaine; Drug: Liposomal bupivacaine; Use of Liposomal bupivacaine in laparoscopic TAP block; Other Names: Exparel

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Benefit of Anesthesia scores (OBAS) on postoperative days 1,2 and 7	Overall Benefit of Anesthesia Scores (OBAS) Questionnaires at postoperative days 1,2 and 7.; OBAS covers pain, vomiting, itching, sweating, freezing, dizziness and overall satisfaction on a scale of 0 to 10.	One week

Collaborators and Investigators

• Sponsor: University of Tennessee
• Investigators: Principal Investigator: Shanti I Mohling, MD, University of Tennessee

Study record dates

Study Major Dates

• Study Start: March 1, 2015
• Primary Completion (Actual): May 1, 2016
• Study Completion (Actual): May 1, 2016

Study Registration Dates

• First Submitted: March 11, 2015
• First Submitted That Met QC Criteria: March 26, 2015
• First Posted (Estimate): March 27, 2015

Study Record Updates

• Last Update Posted (Actual): April 28, 2020
• Last Update Submitted That Met QC Criteria: April 27, 2020
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Keywords: laparoscopic hysterectomy; robotic assisted hysterectomy
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anesthetics; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Anesthetics, Local; Ketorolac; Bupivacaine
• Other Study ID Numbers: 14-132