Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-30 @ 7:50 PM
Study NCT ID:
NCT07426666
Status:
COMPLETED
Last Update Posted:
2026-02-23
First Post:
2026-02-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vaginal Cuff Bupivacaine Injection for Postoperative Pain
Sponsor:
Havva Betül Bacak
Organization:
Study Overview
Official Title:
The Effect of Vaginal Cuff Bupivacaine Injection on Postoperative Pain After Vaginal Hysterectomy
Status:
COMPLETED
Status Verified Date:
2026-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
marcaine
Brief Summary:
This randomized controlled study evaluates whether injecting bupivacaine into the vaginal cuff during vaginal hysterectomy reduces postoperative pain. Vaginal hysterectomy is commonly performed for benign gynecologic conditions. Although it is associated with less pain compared to abdominal surgery, postoperative discomfort may still affect recovery and patient satisfaction.
In this study, 48 women undergoing elective vaginal hysterectomy were randomly assigned to two groups. In the intervention group, 0.25% bupivacaine was injected bilaterally into the vaginal cuff after closure. In the control group, no local anesthetic injection was administered. All patients received the same standard postoperative pain management protocol.
Pain levels were measured using the Visual Analog Scale (VAS) at 1, 3, 6, 12, and 24 hours after surgery. Additional analgesic consumption and possible complications were also recorded. The study aims to determine whether vaginal cuff bupivacaine infiltration improves early postoperative pain control.
In this study, 48 women undergoing elective vaginal hysterectomy were randomly assigned to two groups. In the intervention group, 0.25% bupivacaine was injected bilaterally into the vaginal cuff after closure. In the control group, no local anesthetic injection was administered. All patients received the same standard postoperative pain management protocol.
Pain levels were measured using the Visual Analog Scale (VAS) at 1, 3, 6, 12, and 24 hours after surgery. Additional analgesic consumption and possible complications were also recorded. The study aims to determine whether vaginal cuff bupivacaine infiltration improves early postoperative pain control.
Detailed Description:
This prospective, single-center, randomized controlled trial was conducted to evaluate the effect of bilateral vaginal cuff infiltration with 0.25% bupivacaine on postoperative pain following vaginal hysterectomy performed for benign gynecologic indications.
Vaginal hysterectomy, although minimally invasive, may still be associated with significant postoperative discomfort. The uterus and surrounding structures receive innervation from the uterosacral plexus (Lee-Frankenhauser plexus), which plays a role in postoperative pain transmission. Local anesthetic infiltration targeting this anatomical region may reduce nociceptive signaling and improve early postoperative pain control.
A total of 48 women aged 35-75 years scheduled for elective vaginal hysterectomy were randomized using a sealed-envelope method into two parallel groups:
Intervention group (n=24): Bilateral infiltration of 10 mL 0.25% bupivacaine into the lateral aspects of the vaginal cuff following cuff closure.
Control group (n=24): Standard surgical procedure without local anesthetic infiltration.
All procedures were performed under general anesthesia. Postoperative analgesia was administered according to institutional standard protocol. Pain intensity was assessed using the Visual Analog Scale (VAS) at postoperative 1, 3, 6, 12, and 24 hours.
The primary outcome was postoperative pain intensity measured by VAS scores. Secondary outcomes included total analgesic consumption within the first 24 hours, intraoperative and postoperative complications, and length of hospital stay.
The study was completed after enrollment of 40 participants, and outcomes were analyzed to determine the efficacy and safety of vaginal cuff bupivacaine infiltration in reducing early postoperative pain following vaginal hysterectomy.
Vaginal hysterectomy, although minimally invasive, may still be associated with significant postoperative discomfort. The uterus and surrounding structures receive innervation from the uterosacral plexus (Lee-Frankenhauser plexus), which plays a role in postoperative pain transmission. Local anesthetic infiltration targeting this anatomical region may reduce nociceptive signaling and improve early postoperative pain control.
A total of 48 women aged 35-75 years scheduled for elective vaginal hysterectomy were randomized using a sealed-envelope method into two parallel groups:
Intervention group (n=24): Bilateral infiltration of 10 mL 0.25% bupivacaine into the lateral aspects of the vaginal cuff following cuff closure.
Control group (n=24): Standard surgical procedure without local anesthetic infiltration.
All procedures were performed under general anesthesia. Postoperative analgesia was administered according to institutional standard protocol. Pain intensity was assessed using the Visual Analog Scale (VAS) at postoperative 1, 3, 6, 12, and 24 hours.
The primary outcome was postoperative pain intensity measured by VAS scores. Secondary outcomes included total analgesic consumption within the first 24 hours, intraoperative and postoperative complications, and length of hospital stay.
The study was completed after enrollment of 40 participants, and outcomes were analyzed to determine the efficacy and safety of vaginal cuff bupivacaine infiltration in reducing early postoperative pain following vaginal hysterectomy.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: