Effect of Trocar Site and Vaginal Cuff Bupivacaine Injection on Postoperative Pain in Patients Undergoing Total Laparoscopic Hysterectomy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Postoperative Pain Intensity Measured by Visual Analog Scale (VAS)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
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.
入排标准
- 年龄范围
- 35 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
研究组 & 干预措施
Intervention Group (Bupivacaine Group)
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.
干预措施: Bupivacaine %0.5 (hyperbaric) (Drug)
Control Group
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.
结局指标
主要结局
Postoperative Pain Intensity Measured by Visual Analog Scale (VAS)
时间窗: Within the first 24 hours after surgery (at 1, 2, 3, 6, 12, and 24 hours postoperatively)
Postoperative pain will be assessed using a 10-cm Visual Analog Scale (VAS), where 0 represents no pain and 10 represents worst imaginable pain.
次要结局
未报告次要终点
研究者
Serkan Kumbasar
Associate Professor of Gynecology and Obstetrics
Gaziosmanpasa Research and Education Hospital