Effect of Local Anesthesia on Postoperative Pain Following Sacrospinous Ligament Fixation
Primary Purpose
Pelvic Organ Prolapse
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Bupivacaine liposomal
Lidocaine
Sponsored by
About this trial
This is an interventional treatment trial for Pelvic Organ Prolapse
Eligibility Criteria
Inclusion Criteria:
- Female gender
- Age ≥ 18 years, ≤95 years
- 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
- Able to give informed consent to participate
Exclusion Criteria:
- Male
- Age <18 years, > 95 years
- Unable or unwilling to give informed consent to participate
- Pregnancy
- History of chronic pelvic pain, narcotic abuse, or daily narcotic usage in the last six months
- Known allergy / intolerance to either lidocaine, bupivacaine liposomal, ketorolac, motrin, or acetaminophen
- Known renal or hepatic insufficiency
- Planned hysterectomy at the time of prolapse repair
- Planned transobturator mid urethral sling at the time of prolapse repair
Sites / Locations
- Hartford Hospital, Urogynecology DivisionRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Lidocaine group
Bupivacaine liposomal group
Arm Description
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
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
Outcomes
Primary Outcome Measures
Visual analog pain scale
post-operative pain
Secondary Outcome Measures
Equivalents of morphine used for pain control post-operative while hospitalized
Post-operative opioid use, in hospital
Equivalents of morphine used from the time of hospital discharge to post-operative day 7
Post-operative opioid use, after hospital discharge
Modified surgical pain scale
Return to baseline pain status
Time to first bowel movement
Days to first postoperative bowel movement
Post-operative antiemetic use, in hospital
Void trial
Results of in-hospital void trial
HCHAPS pain questionnaire
Patient satisfaction with pain control
Full Information
NCT ID
NCT02890199
First Posted
August 26, 2016
Last Updated
October 11, 2016
Sponsor
Hartford Hospital
Collaborators
American Association of Gynecologic Laparoscopists
1. Study Identification
Unique Protocol Identification Number
NCT02890199
Brief Title
Effect of Local Anesthesia on Postoperative Pain Following Sacrospinous Ligament Fixation
Official Title
Effect of Local Anesthesia on Postoperative Pain Following Sacrospinous Ligament Fixation
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Unknown status
Study Start Date
October 2016 (undefined)
Primary Completion Date
June 2017 (Anticipated)
Study Completion Date
July 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hartford Hospital
Collaborators
American Association of Gynecologic Laparoscopists
4. Oversight
Data Monitoring Committee
No
5. Study Description
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:
Lidocaine group (short-acting medication).
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:
post-operative opioid medication use
return to baseline pain status
post-operative time to first bowel movement
post-operative antiemetic use (nausea medication)
results of voiding trial after surgery
patient satisfaction with pain control
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pelvic Organ Prolapse
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Lidocaine group
Arm Type
Active Comparator
Arm Description
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
Arm Title
Bupivacaine liposomal group
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Bupivacaine liposomal
Intervention Type
Drug
Intervention Name(s)
Lidocaine
Primary Outcome Measure Information:
Title
Visual analog pain scale
Description
post-operative pain
Time Frame
1 to 120 hours post-operative
Secondary Outcome Measure Information:
Title
Equivalents of morphine used for pain control post-operative while hospitalized
Description
Post-operative opioid use, in hospital
Time Frame
1-2 days post-operative
Title
Equivalents of morphine used from the time of hospital discharge to post-operative day 7
Description
Post-operative opioid use, after hospital discharge
Time Frame
7 days post-operative
Title
Modified surgical pain scale
Description
Return to baseline pain status
Time Frame
3, 7, 14, 28 days post-operative
Title
Time to first bowel movement
Description
Days to first postoperative bowel movement
Time Frame
1-28 days post-operative
Title
Post-operative antiemetic use, in hospital
Time Frame
1-2 days post-operative
Title
Void trial
Description
Results of in-hospital void trial
Time Frame
1-2 days post-operative
Title
HCHAPS pain questionnaire
Description
Patient satisfaction with pain control
Time Frame
48 hours post-operative
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Female gender
Age ≥ 18 years, ≤95 years
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
Able to give informed consent to participate
Exclusion Criteria:
Male
Age <18 years, > 95 years
Unable or unwilling to give informed consent to participate
Pregnancy
History of chronic pelvic pain, narcotic abuse, or daily narcotic usage in the last six months
Known allergy / intolerance to either lidocaine, bupivacaine liposomal, ketorolac, motrin, or acetaminophen
Known renal or hepatic insufficiency
Planned hysterectomy at the time of prolapse repair
Planned transobturator mid urethral sling at the time of prolapse repair
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Katie Propst, MD
Phone
860-972-4338
Email
katie.propst@hhchealth.org
First Name & Middle Initial & Last Name or Official Title & Degree
David M. O'Sullivan, PhD
Email
david.o'sullivan@hhchealth.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Katie Propst, MD
Organizational Affiliation
Hartford Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hartford Hospital, Urogynecology Division
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06106
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katie Propst, MD
Phone
860-972-4338
Email
katie.propst@hhchealth.org
12. IPD Sharing Statement
Plan to Share IPD
No
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Effect of Local Anesthesia on Postoperative Pain Following Sacrospinous Ligament Fixation
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