TAP Block With Liposomal Bupivacaine Versus Pre-incisional Wound Infiltration With Bupivacaine for Postoperative Pain (LATAP)
Primary Purpose
Postoperative Pain
Status
Terminated
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Pre-incisional wound infiltration
Laparoscope to place TAP block with liposomal bupivacaine
Liposomal bupivacaine
Bupivacaine
Ketorolac
Sponsored by
About this trial
This is an interventional prevention trial for Postoperative Pain focused on measuring laparoscopic hysterectomy, robotic assisted hysterectomy
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Group A: pre-incisional bupivacaine
Group B: laparoscope to place TAP block
Arm Description
Intervention: Pre-incisional wound infiltration with bupivacaine plain 0.25%. Ketorolac 30mg IV will be given following surgical procedure.
Intervention: laparoscope to place TAP block with liposomal bupivacaine and bupivacaine plain 0.25%. Ketorolac 30 mg IV will be given following surgical procedure.
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
Narcotic pain medication usage
Narcotic pain medication usage intraoperative and in recovery assessed as morphine equivalents
Narcotic pain medication following surgery
Narcotic pain medication pill counts up to one week postoperatively
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02400645
Brief Title
TAP Block With Liposomal Bupivacaine Versus Pre-incisional Wound Infiltration With Bupivacaine for Postoperative Pain
Acronym
LATAP
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
2. Study Status
Record Verification Date
March 2015
Overall Recruitment Status
Terminated
Why Stopped
It was determined that one member of the team had falsified data.
Study Start Date
March 2015 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
May 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Tennessee
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
Keywords
laparoscopic hysterectomy, robotic assisted hysterectomy
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
69 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A: pre-incisional bupivacaine
Arm Type
Active Comparator
Arm Description
Intervention: Pre-incisional wound infiltration with bupivacaine plain 0.25%. Ketorolac 30mg IV will be given following surgical procedure.
Arm Title
Group B: laparoscope to place TAP block
Arm Type
Active Comparator
Arm Description
Intervention: laparoscope to place TAP block with liposomal bupivacaine and bupivacaine plain 0.25%. Ketorolac 30 mg IV will be given following surgical procedure.
Intervention Type
Procedure
Intervention Name(s)
Pre-incisional wound infiltration
Intervention Description
Intraoperative: Pre-incisional bupivacaine 0.25% up to 20 cc divided dose for trocar incisions
Intervention Type
Procedure
Intervention Name(s)
Laparoscope to place TAP block with liposomal bupivacaine
Other Intervention Name(s)
Laparoscopic TAP block with Liposomal bupivacaine
Intervention Description
Intraoperative: Laparoscopic TAP block with Liposomal bupivacaine and bupivacaine 0.25%
Intervention Type
Drug
Intervention Name(s)
Liposomal bupivacaine
Other Intervention Name(s)
Exparel
Intervention Description
Use of Liposomal bupivacaine in laparoscopic TAP block
Intervention Type
Drug
Intervention Name(s)
Bupivacaine
Other Intervention Name(s)
Marcaine
Intervention Description
20 cc Bupivacaine 0.25% plain will be used for either pre-incisional injection or added to laparoscopic TAP block solution.
Intervention Type
Drug
Intervention Name(s)
Ketorolac
Other Intervention Name(s)
Toradol
Intervention Description
Ketorolac 30mg to be given IV at end of surgical procedure unless contraindicated.
Primary Outcome Measure Information:
Title
Visual Analog pain scores (VAS)
Description
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)
Time Frame
Two hours
Secondary Outcome Measure Information:
Title
Narcotic pain medication usage
Description
Narcotic pain medication usage intraoperative and in recovery assessed as morphine equivalents
Time Frame
2 hours postoperative
Title
Narcotic pain medication following surgery
Description
Narcotic pain medication pill counts up to one week postoperatively
Time Frame
1 week
Other Pre-specified Outcome Measures:
Title
Overall Benefit of Anesthesia scores (OBAS) on postoperative days 1,2 and 7
Description
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.
Time Frame
One week
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shanti I Mohling, MD
Organizational Affiliation
University of Tennessee
Official's Role
Principal Investigator
12. IPD Sharing Statement
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TAP Block With Liposomal Bupivacaine Versus Pre-incisional Wound Infiltration With Bupivacaine for Postoperative Pain
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