Bupivacaine for Postoperative Pain After Laparoscopic Hysterectomy

Official title

Effect of Trocar Site and Vaginal Cuff Bupivacaine Injection on Postoperative Pain in Patients Undergoing Total Laparoscopic Hysterectomy

Overview

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.

Detailed description

Total laparoscopic hysterectomy (TLH) is widely performed for benign gynecologic conditions and is associated with shorter hospital stay and faster recovery compared with open surgery. However, postoperative pain remains a relevant clinical concern. Pain after TLH may originate from abdominal trocar entry sites as well as surgical manipulation and suturing of the vaginal cuff.

Local anesthetic infiltration is a component of multimodal analgesia strategies aimed at reducing postoperative pain and opioid consumption. Bupivacaine, a long-acting amide-type local anesthetic, has been used for surgical wound infiltration with variable results. While previous studies have evaluated trocar site infiltration alone, limited data are available regarding the combined infiltration of both trocar sites and the vaginal cuff in patients undergoing TLH.

This study is designed as a prospective, randomized, single-blind controlled trial conducted at a tertiary referral center. Eligible patients undergoing TLH for benign indications will be randomized into two groups. In the intervention group, a total of 10 mL solution containing 5 mL of 0.5% bupivacaine (Marcaine) diluted with 5 mL 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 (a total of 2 ml into both sacrouterin ligaments). 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 local anesthetic infiltration. All surgical procedures will be performed using a standardized TLH technique by the same surgical team.

Pain intensity will be assessed using repeated measurements over the first 24 postoperative hours. The study will also evaluate recovery-related parameters and safety outcomes. Statistical analysis will be performed using mixed-effects modeling to account for repeated pain measurements over time, with a two-sided significance level of 0.05.

Interventions

• Drug Bupivacaine %0.5 (hyperbaric)
  Participants undergoing total laparoscopic hysterectomy will receive 0.5% bupivacaine infiltration at the end of surgery. A total of 10 mL of 0.5% bupivacaine will be administered: 2 mL to each of the four trocar sites (total 8 mL) and 1 mL bilaterally to the vaginal cuff (total 2 mL) prior to trocar removal. All other perioperative management and postoperative analgesia protocols will be standardized.

Primary outcome measures

• Postoperative Pain Intensity Measured by Visual Analog Scale (VAS) [Time frame: Within the first 24 hours after surgery (at 1, 2, 3, 6, 12, and 24 hours postoperatively)]

Eligibility criteria

Inclusion criteria

• 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)

Exclusion criteria

• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Turkey (Türkiye) · 1 center

• SBÜ Gaziosmanpaşa Training and Research Hospital — Istanbul

Identifiers

NCT: NCT07435909 · bupivacaine-tlh

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗