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| Name | Class |
|---|---|
| American Association of Gynecologic Laparoscopists | OTHER |
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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:
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lidocaine group | Active Comparator | 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 |
|
| Bupivacaine liposomal group | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bupivacaine liposomal | Drug |
| ||
| Lidocaine |
| Measure | Description | Time Frame |
|---|---|---|
| Visual analog pain scale | post-operative pain | 1 to 120 hours post-operative |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Katie Propst, MD | Contact | 860-972-4338 | katie.propst@hhchealth.org | |
| David M. O'Sullivan, PhD | Contact | david.o'sullivan@hhchealth.org |
| Name | Affiliation | Role |
|---|---|---|
| Katie Propst, MD | Hartford Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hartford Hospital, Urogynecology Division | Recruiting | Hartford | Connecticut | 06106 | United States |
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| ID | Term |
|---|---|
| D056887 | Pelvic Organ Prolapse |
| ID | Term |
|---|---|
| D011391 | Prolapse |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D008012 | Lidocaine |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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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 |
| Aniline Compounds |
| D000588 | Amines |