Effect of Local Anesthesia on Postoperative Pain Following Sacrospinous Ligament Fixation

Study Overview
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Brief Summary
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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

Official Title
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Effect of Local Anesthesia on Postoperative Pain Following Sacrospinous Ligament Fixation

Conditions
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Pelvic Organ Prolapse

Intervention / Treatment
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* Drug: Bupivacaine liposomal
* Drug: Lidocaine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 95 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Lidocaine group<br>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<br> <br> |
| Experimental: Bupivacaine liposomal group<br>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<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual analog pain scale | post-operative pain | 1 to 120 hours post-operative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Equivalents of morphine used for pain control post-operative while hospitalized | Post-operative opioid use, in hospital | 1-2 days post-operative | 
| Equivalents of morphine used from the time of hospital discharge to post-operative day 7 | Post-operative opioid use, after hospital discharge | 7 days post-operative | 
| Modified surgical pain scale | Return to baseline pain status | 3, 7, 14, 28 days post-operative | 
| Time to first bowel movement | Days to first postoperative bowel movement | 1-28 days post-operative | 
| Post-operative antiemetic use, in hospital |  | 1-2 days post-operative | 
| Void trial | Results of in-hospital void trial | 1-2 days post-operative | 
| HCHAPS pain questionnaire | Patient satisfaction with pain control | 48 hours post-operative |