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Effect of Local Anesthesia on Postoperative Pain Following Sacrospinous Ligament Fixation

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02890199
Recruitment Status : Unknown
Verified October 2016 by Katie Propst, Hartford Hospital.
Recruitment status was:  Recruiting
First Posted : September 7, 2016
Last Update Posted : October 12, 2016
Sponsor:
Collaborator:
American Association of Gynecologic Laparoscopists
Information provided by (Responsible Party):
Katie Propst, Hartford Hospital

Brief Summary:

During surgery for pelvic organ prolapse, it is common for the surgeon to inject fluid into the vaginal tissues to help with tissue dissection. It is common that anesthetic medication is mixed into this fluid to help with pain control after surgery. Usually the pain medication injected is short-acting. In this study the investigators plan to compare the usual short-acting injected pain medication with a long-acting injected pain medication to evaluate whether this improves pain control after surgery.

One type surgical procedure for prolapse will be evaluated. The procedure is sacrospinous ligament fixation. This is suspension of the vagina to treat pelvic organ prolapse. Study participants will be randomized to one of two study groups:

  1. Lidocaine group (short-acting medication).
  2. Liposomal bupivacaine group (long-acting medication)

Information will be collected on study participants, including: demographics, procedure data, and post-operative information. The primary outcome of this study is determine if use of long-acting injected local anesthesia at the time of sacrospinous ligament fixation leads to less post-operative pain compared to short-acting local anesthesia.

Secondary outcomes include:

  1. post-operative opioid medication use
  2. return to baseline pain status
  3. post-operative time to first bowel movement
  4. post-operative antiemetic use (nausea medication)
  5. results of voiding trial after surgery
  6. patient satisfaction with pain control

Condition or disease Intervention/treatment Phase
Pelvic Organ Prolapse Drug: Bupivacaine liposomal Drug: Lidocaine Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Local Anesthesia on Postoperative Pain Following Sacrospinous Ligament Fixation
Study Start Date : October 2016
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : July 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Lidocaine group
0.5% lidocaine mixed with 1:200,000 epinephrine 70 milliliters (mL) will be used for local injection at the sacrospinous ligament and for anterior / posterior colporrhaphy
Drug: Lidocaine
Experimental: Bupivacaine liposomal group
1.3% bupivacaine liposomal (20 mL) injected at the sacrospinous ligament 0.5% lidocaine mixed with 1:200,000 epinephrine 50mL for the anterior / posterior colporrhaphy
Drug: Bupivacaine liposomal



Primary Outcome Measures :
  1. Visual analog pain scale [ Time Frame: 1 to 120 hours post-operative ]
    post-operative pain


Secondary Outcome Measures :
  1. Equivalents of morphine used for pain control post-operative while hospitalized [ Time Frame: 1-2 days post-operative ]
    Post-operative opioid use, in hospital

  2. Equivalents of morphine used from the time of hospital discharge to post-operative day 7 [ Time Frame: 7 days post-operative ]
    Post-operative opioid use, after hospital discharge

  3. Modified surgical pain scale [ Time Frame: 3, 7, 14, 28 days post-operative ]
    Return to baseline pain status

  4. Time to first bowel movement [ Time Frame: 1-28 days post-operative ]
    Days to first postoperative bowel movement

  5. Post-operative antiemetic use, in hospital [ Time Frame: 1-2 days post-operative ]
  6. Void trial [ Time Frame: 1-2 days post-operative ]
    Results of in-hospital void trial

  7. HCHAPS pain questionnaire [ Time Frame: 48 hours post-operative ]
    Patient satisfaction with pain control



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 95 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Female gender
  2. Age ≥ 18 years, ≤95 years
  3. Planned vaginal sacrospinous ligament fixation with anterior and/or posterior colporrhaphy (SSLF APC) to treat pelvic organ prolapse with or without retropubic mid urethral sling
  4. Able to give informed consent to participate

Exclusion Criteria:

  1. Male
  2. Age <18 years, > 95 years
  3. Unable or unwilling to give informed consent to participate
  4. Pregnancy
  5. History of chronic pelvic pain, narcotic abuse, or daily narcotic usage in the last six months
  6. Known allergy / intolerance to either lidocaine, bupivacaine liposomal, ketorolac, motrin, or acetaminophen
  7. Known renal or hepatic insufficiency
  8. Planned hysterectomy at the time of prolapse repair
  9. Planned transobturator mid urethral sling at the time of prolapse repair

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): NCT02890199


Contacts
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Contact: Katie Propst, MD 860-972-4338 katie.propst@hhchealth.org
Contact: David M. O'Sullivan, PhD david.o'sullivan@hhchealth.org

Locations
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United States, Connecticut
Hartford Hospital, Urogynecology Division Recruiting
Hartford, Connecticut, United States, 06106
Contact: Katie Propst, MD    860-972-4338    katie.propst@hhchealth.org   
Sponsors and Collaborators
Hartford Hospital
American Association of Gynecologic Laparoscopists
Investigators
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Principal Investigator: Katie Propst, MD Hartford Hospital
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Responsible Party: Katie Propst, Fellow, Hartford Hospital
ClinicalTrials.gov Identifier: NCT02890199    
Other Study ID Numbers: HHC-2016-0169
First Posted: September 7, 2016    Key Record Dates
Last Update Posted: October 12, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Pain, Postoperative
Prolapse
Pelvic Organ Prolapse
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Pathological Conditions, Anatomical
Lidocaine
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action