Paracervical Injection and Opioid Use After Vaginal Hysterectomy for Prolapse

University of North Carolina (UNC)

Status and phase: Enrolling; Phase 4

Conditions: Postoperative Pain; Surgical Recovery; Vaginal Hysterectomy; Opioid Use; Prolapse Pelvic

Treatments: Drug: Bupivacaine-epinephrine; Drug: Normal saline

Study type: Interventional

Funder types: Other

Identifiers

NCT07213635

25-0619

Details and patient eligibility

About

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:

• Receive either an injection of the numbing medicine (bupivacaine with lidocaine) or saltwater liquid placebo after they are asleep but before any other parts of the surgery are done
• Record and report pain medications used for 7 days after surgery
• Report pain scores before discharge from the post anesthesia recovery area on day of surgery as well as 1 and 7 days after surgery
• Complete a surgical recovery questionnaire during 6 week postoperative visit
• Complete a one page multiple-choice test on pelvic organ prolapse

Full description

Secondary outcomes are to:

1. Compare postoperative pain scores in patients undergoing vaginal hysterectomy for prolapse repair who receive an intraoperative paracervical block compared to placebo
2. Compare surgical recovery times in patients undergoing vaginal hysterectomy for prolapse repair who receive an intraoperative paracervical block compared to placebo.
3. Examine incidence of adverse events in patients undergoing vaginal hysterectomy for prolapse repair who receive intraoperative paracervical block compared to placebo

Enrollment: 56 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Individuals undergoing vaginal hysterectomy with concomitant prolapse repair procedure

Exclusion criteria

• Non-English speaking
• Weight less than 50 kg
• Allergy to bupivacaine
• Pregnant

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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56 participants in 2 patient groups, including a placebo group

Paracervical block

Experimental group

Description:

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

Treatment:

Drug: Bupivacaine-epinephrine

Placebo

Placebo Comparator group

Description:

Participants randomized to this experimental arm will receive a placebo paracervical injection with normal saline at the time of vaginal hysterectomy with prolapse repair

Treatment:

Drug: Normal saline