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Vaginal Cuff Infiltration With Liposomal Bupivacaine for Pain Relief: A Double Blind, Randomized Controlled Trial

Primary Purpose

Postoperative Pain

Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Exparel with Bubivacaine
Bupivacaine only
Sponsored by
Maimonides Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain focused on measuring pain, bupivicaine, local infiltration

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: Any patient age > 18 years who is having minimally invasive robotic or laparoscopic total hysterectomy for any indication without any anesthetic block. Exclusion Criteria: 1) Use of any of the following medications within the times specified before surgery: a. opioid, SSRI, tricyclic antidepressant, gabapentin, pregabalin within three days of surgery. b. Use of acetaminophen within 24 hours of surgery 2) Concurrent painful physical condition or concurrent surgery that may require analgesic treatment (such as NSAID, opioid, SSRI, tricyclic antidepressant, gabapentin, pregabalin) in the postoperative period for pain that is not strictly related to the minimally invasive supracervical hysterectomy procedure and may confound the postoperative assessments (e.g., rheumatoid arthritis, chronic neuropathic pain. 3) Chronic user of analgesic medications, including taking opioid medications for more than 14 days in the last 3 months, or nonopioid pain medications more than 5 times per week. 4) Current use of systemic glucocorticosteroids (e.g. Decadron) or use of glucocorticoids within one month of enrollment into this study. 5) History of hepatitis (other than hepatitis A). 6) History of hypersensitivity or idiosyncratic reactions to amide type local anesthetics, opioids, or propofol. 7) Administration of an investigational drug within 30 days prior to study drug administration, or planned administration of another investigational product or procedure during the subject's participation in this study. 8) Uncontrolled anxiety, schizophrenia, or other psychiatric disorder that, in the opinion of the Investigator, may interfere with study assessments or compliance. 9) Significant medical conditions or laboratory results that, in the opinion of the Investigator indicate an increased vulnerability to study drug and procedures, and expose subjects to an unreasonable risk as a result of participating in this clinical trial. 10) Any clinically significant event or condition uncovered during the surgery (e.g., excessive bleeding, acute sepsis) that might render the subject medically unstable or complicate the subject's postoperative course. 11) women with endometriosis 12) contraindications to any medication used in the study (acetaminophen, NSAID or opioid).

Sites / Locations

  • Maimonides Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Exparel and Bupivacaine Group

Bupivacaine Only Group

Arm Description

The participants in this group will receive 10 ml of xxparel and 10 ml of bupivacaine in the vaginal cuff

This group will receive 20ml of bupivicaine in the vaginal cuff

Outcomes

Primary Outcome Measures

Pain reduction after surgery
A reduction in pain on a 11 point Likert Scale with 0 being no pain and 10 being very severe pain.

Secondary Outcome Measures

Full Information

First Posted
April 10, 2023
Last Updated
April 20, 2023
Sponsor
Maimonides Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT05823363
Brief Title
Vaginal Cuff Infiltration With Liposomal Bupivacaine for Pain Relief: A Double Blind, Randomized Controlled Trial
Official Title
Vaginal Cuff Infiltration With Liposomal Bupivacaine for Pain Relief: A Double Blind, Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 10, 2023 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Maimonides Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The goal is to find out if Exparel (liposomal bupivacaine) given as an injection decreases pain score if given into the vaginal cuff right before starting the minimally invasive (robotic-assisted or laparoscopic) total hysterectomy in patients scheduled for benign indication? Participants will write down pain score at various intervals pain medication used Treatment patients will receive 1)intervention arm will receive Exparel mixed with bupivicaine 2)control arm will receive bupivicaine only
Detailed Description
The question is whether Exparel (liposomal bupivacaine) given as an injection decreases pain score if given into the vaginal cuff right before starting the minimally invasive (robotic-assisted or laparoscopic) total hysterectomy? A reduction in pain after the surgery would result in decrease in opioid usage, fewer opioid-related adverse events, and increased satisfaction in patients. Intervention arm (40) will get 10ml of Exparel diluted with 10 ml of bupivacaine around 2,4, 8 and 10 o' clock in vaginal cuff. Placebo group (40) will receive 20 ml of normal saline in vaginal cuff. All women 35-75 years age range scheduled for Laparoscopic and robotic hysterectomies with Bilateral salpingectomy or bilateral salpingo-oophorectomy will be assessed for eligibility. It is a prospective interventional study that involves use of liposomal bupivacaine and this study will be run in Maimonides medical center's gynecology department . The severity of pain will be assessed preoperatively in the holding area, at the time of PACU arrival, and at 1hour, 12, 24, 48 and 72hours postoperatively using a VAS from 0 to 10 with 10 being the worst pain the patient has ever experienced. The first 3 assessments will be performed in the hospital by the principal investigators and the remaining assessments will happen through a phone conversation with the patient after discharge from hospital. The VAS has been found to be a simple scale. The data will also be collected through chart review and. this data will include age, VAS score reporting by nurses in PACU, BMI, previous abdominal surgery, previous vaginal delivery and parity. Pain inquiries will assess low pelvic/suprapubic area and lower abdominal pain, type of pain (dull, achy, sharp, stabbing, etc.) and radiation of pain to a surrounding area. Other endpoints will include number of patients who required break through (additional) opioid analgesic medications, median time to first break through opioid use, total opioid analgesic requirement. The time, day and number of requests for break-through (additional) analgesia will be noted by gynecologic surgery team (Research assistant) participating in this study. When the patient is home the patient will have a Pain Medication Diary that the investigators will provide for the patient prior to discharge. Patient will be contacted over phone to get the data from her log sheet.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
Keywords
pain, bupivicaine, local infiltration

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Masking Description
double blind
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Exparel and Bupivacaine Group
Arm Type
Experimental
Arm Description
The participants in this group will receive 10 ml of xxparel and 10 ml of bupivacaine in the vaginal cuff
Arm Title
Bupivacaine Only Group
Arm Type
Active Comparator
Arm Description
This group will receive 20ml of bupivicaine in the vaginal cuff
Intervention Type
Drug
Intervention Name(s)
Exparel with Bubivacaine
Intervention Description
10ml Exparel mixed with10ml bupivicaine in vaginal cuff
Intervention Type
Drug
Intervention Name(s)
Bupivacaine only
Intervention Description
20ml of Bubivacaine in the vaginal cugg
Primary Outcome Measure Information:
Title
Pain reduction after surgery
Description
A reduction in pain on a 11 point Likert Scale with 0 being no pain and 10 being very severe pain.
Time Frame
72 hours after surgery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Any patient age > 18 years who is having minimally invasive robotic or laparoscopic total hysterectomy for any indication without any anesthetic block. Exclusion Criteria: 1) Use of any of the following medications within the times specified before surgery: a. opioid, SSRI, tricyclic antidepressant, gabapentin, pregabalin within three days of surgery. b. Use of acetaminophen within 24 hours of surgery 2) Concurrent painful physical condition or concurrent surgery that may require analgesic treatment (such as NSAID, opioid, SSRI, tricyclic antidepressant, gabapentin, pregabalin) in the postoperative period for pain that is not strictly related to the minimally invasive supracervical hysterectomy procedure and may confound the postoperative assessments (e.g., rheumatoid arthritis, chronic neuropathic pain. 3) Chronic user of analgesic medications, including taking opioid medications for more than 14 days in the last 3 months, or nonopioid pain medications more than 5 times per week. 4) Current use of systemic glucocorticosteroids (e.g. Decadron) or use of glucocorticoids within one month of enrollment into this study. 5) History of hepatitis (other than hepatitis A). 6) History of hypersensitivity or idiosyncratic reactions to amide type local anesthetics, opioids, or propofol. 7) Administration of an investigational drug within 30 days prior to study drug administration, or planned administration of another investigational product or procedure during the subject's participation in this study. 8) Uncontrolled anxiety, schizophrenia, or other psychiatric disorder that, in the opinion of the Investigator, may interfere with study assessments or compliance. 9) Significant medical conditions or laboratory results that, in the opinion of the Investigator indicate an increased vulnerability to study drug and procedures, and expose subjects to an unreasonable risk as a result of participating in this clinical trial. 10) Any clinically significant event or condition uncovered during the surgery (e.g., excessive bleeding, acute sepsis) that might render the subject medically unstable or complicate the subject's postoperative course. 11) women with endometriosis 12) contraindications to any medication used in the study (acetaminophen, NSAID or opioid).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nimra Dad, MD
Phone
9174458918
Email
ndad@maimonidesmed.org
First Name & Middle Initial & Last Name or Official Title & Degree
Amro Elfeky, MD
Phone
631-507-7352
Email
aelfeky@maimonidesmed.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Scott Chudnoff, MD
Organizational Affiliation
MMC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maimonides Medical Center
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11219
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nimra Dad, MD
Phone
917-445-8918
Email
ndad@maimonidesmed.org
First Name & Middle Initial & Last Name & Degree
Amro Elfeky, MD
Phone
6315077352
Email
aelfeky@maimonidesmed.org

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28802593
Citation
Ishio J, Komasawa N, Kido H, Minami T. Evaluation of ultrasound-guided posterior quadratus lumborum block for postoperative analgesia after laparoscopic gynecologic surgery. J Clin Anesth. 2017 Sep;41:1-4. doi: 10.1016/j.jclinane.2017.05.015. Epub 2017 Jun 1.
Results Reference
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Vaginal Cuff Infiltration With Liposomal Bupivacaine for Pain Relief: A Double Blind, Randomized Controlled Trial

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