Bupivacaine for Postoperative Pain After Laparoscopic Hysterectomy

NCT07435909 | Recruiting

• 1 other identifier: bupivacaine-tlh
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective, randomized, single-blind controlled study aims to evaluate the effect of bupivacaine injection at trocar entry sites and the vaginal cuff on postoperative pain in patients undergoing total laparoscopic hysterectomy for benign gynecologic conditions. Postoperative pain after laparoscopic hysterectomy may arise from trocar insertion sites and surgical manipulation of the vaginal cuff. Local anesthetic infiltration may reduce somatic pain and improve early recovery. Eligible patients will be randomly assigned to either receive 0.5% bupivacaine injection at trocar sites and the vaginal cuff at the end of surgery or receive no local anesthetic injection (control group). All patients will receive standard postoperative analgesia. Postoperative pain will be assessed using the Visual Analog Scale (VAS) at 1, 2, 3, 6, 12, and 24 hours after surgery. Secondary outcomes include additional analgesic requirement, time to first mobilization, time to first flatus, length of hospital stay, and postoperative complications.

Conditions

Postoperative Pain

Keywords

bupivacaine

Outcome Measures

Primary Outcomes (1)

• Postoperative Pain Intensity Measured by Visual Analog Scale (VAS)

  Postoperative pain will be assessed using a 10-cm Visual Analog Scale (VAS), where 0 represents no pain and 10 represents worst imaginable pain.

  Within the first 24 hours after surgery (at 1, 2, 3, 6, 12, and 24 hours postoperatively)

Study Arms (2)

Intervention Group (Bupivacaine Group)

EXPERIMENTAL

Participants undergoing total laparoscopic hysterectomy will receive 0.5% bupivacaine infiltration at the end of surgery. A total of 10 mL solution will be administered: 5 mL to the 10 mm trocar site and 5 mL distributed among the three 5 mm trocar sites. In addition, bupivacaine will be injected into the vaginal cuff region prior to trocar removal. All other perioperative management and postoperative analgesia protocols will be standardized.

Drug: Bupivacaine %0.5 (hyperbaric)

Control Group

NO INTERVENTION

Participants undergoing total laparoscopic hysterectomy will not receive local anesthetic infiltration at the trocar sites or vaginal cuff. All other surgical procedures and postoperative analgesia protocols will be identical to those of the intervention group.

Interventions

Bupivacaine %0.5 (hyperbaric) DRUG

Participants undergoing total laparoscopic hysterectomy will receive 0.5% bupivacaine infiltration at the end of surgery. A total of 12 mL of 0.5% bupivacaine will be administered: 2 mL to each of the four trocar sites (total 8 mL) and 2 mL bilaterally to the vaginal cuff (total 4 mL) prior to trocar removal. All other perioperative management and postoperative analgesia protocols will be standardized.

Intervention Group (Bupivacaine Group)

Eligibility Criteria

• Age: 35 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female patients aged 35-75 years
• Scheduled for total laparoscopic hysterectomy for benign gynecologic conditions, including leiomyoma uteri, adenomyosis, abnormal uterine bleeding, endometrial pathology (non-atypical hyperplasia, endometrial thickening, or polyps), cervical intraepithelial lesions (CIN 2-3) without evidence of invasion and indicated for therapeutic hysterectomy, chronic pelvic pain, or benign uterine prolapse
• American Society of Anesthesiologists (ASA) physical status class I-II
• Cognitive ability sufficient to assess and report postoperative pain (no dementia or severe psychiatric disorder)
• Provision of written informed consent
• Completion of surgery laparoscopically as planned (no conversion to laparotomy)

You may not qualify if:

• Presence or suspicion of malignant gynecologic disease
• History of allergy or hypersensitivity to bupivacaine or other amide-type local anesthetics
• History of chronic pain syndrome, analgesic dependence, or regular use of opioids or nonsteroidal anti-inflammatory drugs (NSAIDs)
• Severe systemic disease (e.g., uncontrolled diabetes mellitus, hepatic or renal insufficiency, or heart failure)
• Neurological or psychiatric disorders that impair the ability to assess or report pain

Sponsors & Collaborators

• Serkan Kumbasar: lead

Study Sites (1)

SBÜ Gaziosmanpaşa Training and Research Hospital

Istanbul, gaziosmanpaşa, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Central Study Contacts

serkan kumbasar, md

CONTACT

5067873216; drserkankumbasar@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: This study is designed as a single-blind trial. Participants are unaware of group allocation. The investigator responsible for postoperative pain assessment is also blinded to treatment assignment. The operating surgeon is not blinded due to the nature of the intervention.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor of Gynecology and Obstetrics

Model Details: Participants will be randomly assigned in a 1:1 ratio to one of two parallel groups. In the intervention group, a total of 10 mL solution containing 5 mL of 0.5% bupivacaine (Marcaine) diluted with 5 mL of normal saline will be administered at the end of surgery. Under laparoscopic visualization, 1 mL of the solution will be injected bilaterally into the sacrouterine ligament regions adjacent to the vaginal cuff. After trocar removal, the remaining solution will be infiltrated into the trocar entry sites using an injector from the subcutaneous tissue down to the fascial layer (approximately 2 mL per trocar site). The control group will not receive any local anesthetic infiltration. Outcomes will be compared between groups during the first 24 postoperative hours, and no crossover between groups will occur.

Study Record Dates

• First Submitted: February 18, 2026
• First Posted: February 27, 2026
• Study Start: August 28, 2025
• Primary Completion (Estimated): June 4, 2026
• Study Completion (Estimated): June 4, 2026
• Last Updated: March 10, 2026

Record last verified: 2026-02

Locations

TU (1)