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The goal of the study to see if giving a numbing medicine around the cervix (called a paracervical block) during vaginal hysterectomy with prolapse repair helps people feel less pain and need fewer strong pain medicines afterward.
The main question it aims to answer is:
• Does receiving a paracervical block at the time of vaginal hysterectomy with prolapse repair reduce postoperative opioid use?
Researchers will compare opioid use in participants who receive the an injected numbing medicine (bupivacaine with lidocaine) to those that receive a saltwater liquid placebo.
Participants will:
Secondary outcomes are to:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Paracervical block | Experimental | Participants randomized to this experimental arm will receive a paracervical block with 0.5% bupivacaine with epinephrine at the time of vaginal hysterectomy with prolapse repair |
|
| Placebo | Placebo Comparator | Participants randomized to this experimental arm will receive a placebo paracervical injection with normal saline at the time of vaginal hysterectomy with prolapse repair |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bupivacaine-epinephrine | Drug | Participants randomized to this experimental arm will receive a paracervical block with 10 mL 0.5% bupivacaine with epinephrine before their vaginal hysterectomy and prolapse repair |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative opioid use | Mean postoperative opioid use converted to morphine milligram equivalents | Assessed verbally during a 5 minute phone call on day 1 and 7 following surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Pain score | Mean numeric visual analog pain score from 0-10 where 0 is "no pain" and 10 is "worst pain you can imagine" | Assessed verbally prior to discharge from post anesthesia recovery area, and during 5 minute phone call on day 1 and 7 following surgery |
| Global Surgical Recovery score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bertie Geng, MD | Contact | 984-974-0496 | bertie.geng@unchealth.unc.edu | |
| Marcella Willis-Gray, MD | Contact | Marcella_Willis-Gray@med.unc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Bertie Geng, MD | University of North Carolina | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of North Carolina Urogynecology and Reconstructive Pelvic Surgery at REX | Recruiting | Raleigh | North Carolina | 27607 | United States |
Deidentified individual data that supports the results will be shared beginning 12 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
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beginning 12 months following publication until 36 months following publication
Investigator has approved IRB, IEC, or REB and an executed data use/sharing agreement with UNC.
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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| Normal saline | Drug | Participants randomized to this experimental arm will receive a placebo paracervical injection with 10 mL 0.5% normal saline before their vaginal hysterectomy and prolapse repair |
|
|
Mean Global Surgical Recovery score (from 0-100%) where 0% is not recovered at all and 100% is fully recovered. |
| Assessed verbally during 5 minute phone call on day 1 and 7 following surgery. |
| Postdischarge Surgical Recovery | Mean Postdischarge Surgical Recovery score (from 0-100) where higher scores denote better recovery. | Assessed during completion of 5 minute survey on week 6 postoperative visit. |
| Adverse events | Number of hospital admission (including on day of surgery) and emergency department presentations as well as additional calls or urgent clinic visits | From day of surgery until week 6 postoperative visit |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |