- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02400645
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
Study Overview
Status
Conditions
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
Enrollment (Actual)
Phase
- Phase 1
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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.
|
Intraoperative: Pre-incisional bupivacaine 0.25% up to 20 cc divided dose for trocar incisions
20 cc Bupivacaine 0.25% plain will be used for either pre-incisional injection or added to laparoscopic TAP block solution.
Other Names:
Ketorolac 30mg to be given IV at end of surgical procedure unless contraindicated.
Other Names:
|
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.
|
20 cc Bupivacaine 0.25% plain will be used for either pre-incisional injection or added to laparoscopic TAP block solution.
Other Names:
Ketorolac 30mg to be given IV at end of surgical procedure unless contraindicated.
Other Names:
Intraoperative: Laparoscopic TAP block with Liposomal bupivacaine and bupivacaine 0.25%
Other Names:
Use of Liposomal bupivacaine in laparoscopic TAP block
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Visual Analog pain scores (VAS)
Time Frame: Two hours
|
|
Two hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Narcotic pain medication usage
Time Frame: 2 hours postoperative
|
Narcotic pain medication usage intraoperative and in recovery assessed as morphine equivalents
|
2 hours postoperative
|
Narcotic pain medication following surgery
Time Frame: 1 week
|
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
Time Frame: One week
|
|
One week
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Shanti I Mohling, MD, University of Tennessee
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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