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Local Anesthetics on Postsurgical Analgesia Following Posterior Colporrhaphy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04032327
Recruitment Status : Recruiting
First Posted : July 25, 2019
Last Update Posted : July 25, 2019
Sponsor:
Information provided by (Responsible Party):
Katherine Dengler, MD, Walter Reed National Military Medical Center

Brief Summary:

Effective post-surgical pain management is a crucial component of a patient's postoperative course following posterior colporrhaphy. Narcotics are the cornerstone for postoperative analgesia with a frequent re-dosing requirement, a lengthy list of side effects and adverse reaction risks. The colorectal, orthopedic and general surgery literatures have reported on an extended-release bupivacaine liposomal injection, Exparel®, which remarkably reduces acute post-operative pain; however, literature regarding this medication specific to Urogynecology and Gynecology is limited.

The investigators propose a prospective, randomized, double blind, trial with 120 subjects recruited from the Walter Reed National Military Medical Center (WRNMMC) Urogynecology Clinic to study postsurgical pain control after posterior repair. There will be two arms in the study; one arm with bupivacaine alone and a second arm with bupivacaine mixed with Exparel®(extended-release, liposomal bupivacaine) injected vaginally in patients undergoing posterior colporrhaphy. Subjects will be randomized to receive either 20 milliliter (mL) of plain bupivacaine or 20mL (10ml+10ml) mixture of bupivacaine plus Exparel®.

The primary objective of the trial will be to evaluate the postsurgical vaginal pain using a visual analog pain scale at days 1, 2, 3 post-procedure. All subjects will have acetaminophen, a non-steroidal anti-inflammatory drug and narcotic pain medication available for pain control regardless of assignment, which is the usual postoperative pain control regimen. The investigators hypothesize a 30% difference in post-operative pain measurements between the two groups.

Additional objectives of this study are to evaluate total medication usage on days 1, 2 and 3 and any post-operative voiding and defecatory dysfunction, comparing the two groups


Condition or disease Intervention/treatment Phase
Postoperative Pain Drug: Exparel plus plain bupivacaine Drug: Bupivacaine Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy of Injectable Local Anesthetics on Postsurgical Analgesia Following Posterior Colporrhaphy: A Prospective, Randomized, Double-Blinded Trial
Actual Study Start Date : July 1, 2018
Estimated Primary Completion Date : July 1, 2020
Estimated Study Completion Date : July 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Plain Bupivacaine
20 mL of 0.25% plain bupivacaine
Drug: Bupivacaine
20 mL of 0.25% plain bupivacaine to be injected vaginally prior to the start of posterior colporrhaphy
Other Name: marcaine

Active Comparator: Exparel plus plain bupivacaine
10 mL of extended release liposomal bupivacaine (Exparel) plus 10 mL of 0.25% plain bupivacaine mixed
Drug: Exparel plus plain bupivacaine
10 mL of extended release liposomal bupivacaine (Exparel) plus 10 mL of 0.25% plain bupivacaine mixed to be injected vaginally prior to the start of posterior colporrhaphy
Other Name: extended release liposomal bupivacaine plus marcaine




Primary Outcome Measures :
  1. Change in pain scores using the Defense and Veterans Pain Rating Scale (visual analog scale) between bupivacaine alone versus Exparel® following posterior colporrhaphy post-operatively [ Time Frame: Subjects will be asked to provide numerical values on postoperative day 1. ]
    Patients will be asked on postoperative day (POD) 1 to provide numerical values from 0-10 (zero being no pain and 10 being the worst pain) utilizing the Defense and Veterans Pain Rating Scale (visual analog scale)

  2. Change in pain scores using the Defense and Veterans Pain Rating Scale (visual analog scale) between bupivacaine alone versus Exparel® following posterior colporrhaphy post-operatively [ Time Frame: Subjects will be asked to provide numerical values on postoperative day 2. ]
    Patients will be asked on postoperative day (POD) 2 to provide numerical values from 0-10 (zero being no pain and 10 being the worst pain) utilizing the Defense and Veterans Pain Rating Scale (visual analog scale)

  3. Change in pain scores using the Defense and Veterans Pain Rating Scale (visual analog scale) between bupivacaine alone versus Exparel® following posterior colporrhaphy post-operatively [ Time Frame: Subjects will be asked to provide numerical values on postoperative day 3. ]
    Patients will be asked on postoperative day (POD) 3 to provide numerical values from 0-10 (zero being no pain and 10 being the worst pain) utilizing the Defense and Veterans Pain Rating Scale (visual analog scale)

  4. Amount of pain medication, especially opioids, required during the postoperative period. [ Time Frame: Calculated throughout hospitalization and/or with phone call on postoperative day 1. ]
    Calculate total postoperative pain medications used while inpatient and perform pill counts on postoperative days 1 (done via a phone call or inpatient). This will allow calculation of total amount of narcotics and other pain medications utilized through postoperative day #1

  5. Amount of pain medication, especially opioids, required during postoperative day 2 [ Time Frame: Calculated with phone call on postoperative day 2. ]
    Calculate total postoperative pain medications used by performing pill counts on postoperative days 2 (done via a phone call). This will allow calculation of total amount of narcotics and other pain medications utilized on postoperative day #2.

  6. Amount of pain medication, especially opioids, required during postoperative day 3 [ Time Frame: Calculated with phone call on postoperative day 3. ]
    Calculate total postoperative pain medications used by performing pill counts on postoperative days 3 (done via a phone call). This will allow calculation of total amount of narcotics and other pain medications utilized on postoperative day #3.


Secondary Outcome Measures :
  1. Rate of post-operative urinary retention after posterior colporrhaphy using an active voiding trial, comparing the bupivacaine plus Exparel® group versus the bupivacaine plain group. [ Time Frame: Postoperative active voiding trial on postoperative day 1. ]
    Investigators will record in patients passed active voiding trail prior to discharge home.

  2. Rate of post-operative defecatory function after posterior colporrhaphy, comparing the bupivacaine plus Exparel® group versus the bupivacaine plain group. [ Time Frame: Postoperatively up to day 3 ]
    Investigators will record in patients have had a bowel movement within the first three days postoperatively.

  3. Impact of pain scores on quality of life measures using Defense and Veterans Pain Rating Scale (visual analog scale) comparing the bupivacaine plus Exparel® group and the bupivacaine plain group [ Time Frame: Subjects will be asked to provide numerical values on postoperative day 1, 2, 3. ]
    Investigators will ask patients to complete four quality of life questions and respond using a 0-10 answer (0 being no pain and 10 being the worst pain) using the Defense and Veterans Pain Rating Scale (visual analog scale). This will be recorded on POD 1, 2, 3



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   females only
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Females >18 years of age undergoing Urogynecologic surgery involving the posterior vaginal wall mucosa or muscularis including posterior colporrhaphy at Walter Reed National Military Medical Center.
  • Patients must be able to read and understand written English or have an appropriate certified medical translator available.

Exclusion Criteria:

  • Known allergy to amide local anesthetics.
  • Unstable cardiac arrhythmia.
  • Hepatic impairment (including but not limited to patients under the care of their physician for severe hepatic disease, cirrhosis or hepatic cancer).
  • Known pregnancy at time of surgery (pregnancy test morning of surgery if applicable).
  • Regular use of narcotic pain medication, defined as use on most days of week at any time in the three months prior to surgery.
  • Significant history of opioid or alcohol abuse or addiction (requiring treatment).
  • Concurrent pain management requiring the use of epidural anesthesia.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04032327


Contacts
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Contact: Katherine L Dengler, MD 301-400-2468 katherine.l.dengler.mil@mail.mil

Locations
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United States, Maryland
Walter Reed National Military Medical Center (WRNMMC) Recruiting
Bethesda, Maryland, United States, 20889
Contact: Katherine L Dengler, MD    301-400-2468    katherine.l.dengler.mil@mail.mil   
Sponsors and Collaborators
Walter Reed National Military Medical Center
Investigators
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Study Chair: Daniel Gruber, MD Walter Reed National Military Medical Center (WRNMMC)

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Responsible Party: Katherine Dengler, MD, FPMRS Fellow, Walter Reed National Military Medical Center
ClinicalTrials.gov Identifier: NCT04032327    
Other Study ID Numbers: 11111
First Posted: July 25, 2019    Key Record Dates
Last Update Posted: July 25, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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.: Yes
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents