Effects of Intrathecal Morphine Compared With Trocar-Site Infiltration and Intraperitoneal Bupivacaine on Postoperative Quality of Recovery and Inflammatory Markers After Laparoscopic Hysterectomy: A Prospective, Randomized, Double-Blind Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Postoperative quality of recovery at 24 hours measured by QoR-15
研究概览
简要总结
This study aims to compare the effects of intrathecal morphine with trocar-site infiltration and intraperitoneal bupivacaine on postoperative pain control, quality of recovery, and inflammatory response in patients undergoing elective laparoscopic hysterectomy. Laparoscopic hysterectomy is widely used for benign gynecologic conditions, but postoperative pain may result from trocar-site trauma, peritoneal irritation, and carbon dioxide insufflation. Effective postoperative analgesia can improve patient comfort, reduce opioid use, and enhance early recovery.
Intrathecal morphine is known to provide potent early postoperative analgesia but may cause side effects such as nausea, vomiting, pruritus, and respiratory depression. Local anesthetic techniques, including trocar-site infiltration and intraperitoneal bupivacaine, have also been shown to reduce postoperative pain after minimally invasive gynecologic surgery.
In this prospective, randomized, double-blind study, patients will be assigned to one of two groups:
Intrathecal morphine (ITM) administered before induction of anesthesia;
Local anesthesia group (LA) receiving trocar-site infiltration and intraperitoneal bupivacaine at the end of surgery.
The primary outcome is the Quality of Recovery-15 (QoR-15) score at 24 hours. Secondary outcomes include pain scores, opioid consumption, time to first rescue analgesia, postoperative nausea and vomiting, pruritus, respiratory depression, early mobilization, bowel function recovery, and perioperative inflammatory markers such as neutrophil-to-lymphocyte ratio (NLR), platelet-to-lymphocyte ratio (PLR), lymphocyte-to-monocyte ratio (LMR), and systemic immune-inflammation index (SII).
The results of this trial are expected to guide clinicians in selecting optimal analgesic strategies for laparoscopic hysterectomy and to contribute to improved patient recovery and postoperative satisfaction.
详细描述
Study Background and Rationale:
Despite its minimally invasive advantages, laparoscopic hysterectomy can cause significant postoperative pain due to trocar sites, visceral manipulation, and peritoneal irritation. This pain results in opioid consumption, associated side effects, and delayed recovery. Multimodal analgesia is the cornerstone of postoperative care. In this context, trocar site infiltration with intrathecal morphine (long-acting central analgesia) and intraperitoneal local anesthetic administration (peripheral techniques targeting somatic and visceral pain) are effective options. This study aims to compare the effects of these two different analgesic strategies on the quality of postoperative recovery through a patient-centered outcome measure, the QoR-15, and objective hematologic inflammatory markers.
Technical Details of Intervention Protocols:
General Anesthesia Standardization: All patients will receive standard general anesthesia. Induction will be achieved with propofol and fentanyl, rocuronium bromide will be used for neuromuscular blockade, and anesthesia will be maintained with sevoflurane.
Group ITM (Intrathecal Morphine) Intervention: Before induction of general anesthesia, patients will be in the sitting or lateral decubitus position and 200 µg (0.2 mg) of morphine will be injected into the subarachnoid space with a 25G (or 27G) pencil-point spinal needle at the L3-L4 intervertebral space. Hemodynamic and respiratory parameters will be closely monitored for 30 minutes after the injection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
This is a double-blind study. Participants and postoperative outcome assessors are blinded to group allocation. Randomization is generated by an independent researcher, and allocation is concealed in sequentially numbered opaque envelopes. The clinician performing the postoperative assessments is not involved in anesthesia administration and remains blinded throughout the study.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients aged 18-65 years.
- •Elective laparoscopic hysterectomy planned for benign gynecological conditions.
- •American Society of Anesthesiologists (ASA) physical status I-III.
- •Ability to provide written informed consent.
排除标准
- •Coagulopathy or bleeding disorders.
- •Opioid dependence or chronic opioid use.
- •Allergy or contraindication to local anesthetics or morphine.
- •Contraindication to neuraxial (spinal) anesthesia.
- •History of chronic pain syndromes.
- •Severe renal or hepatic dysfunction.
- •Pregnancy or breastfeeding.
研究组 & 干预措施
Intrathecal Morphine Group
Participants in this arm will receive 200 µg of preservative-free intrathecal morphine administered at the L3-L4 interspace prior to induction of general anesthesia. This intervention is intended to provide early postoperative analgesia following laparoscopic hysterectomy.
干预措施: Intrathecal Morphine (Drug)
Local Anesthesia Group
Participants in this arm will receive 0.25% bupivacaine infiltration (5 mL at each trocar site) and 40 mL of 0.25% bupivacaine administered intraperitoneally at the end of surgery. The total dose of bupivacaine will not exceed 2 mg/kg. This technique aims to reduce postoperative somatic and visceral pain after laparoscopic hysterectomy.
干预措施: Trocar-Site Bupivacaine Infiltration (Drug)
Local Anesthesia Group
Participants in this arm will receive 0.25% bupivacaine infiltration (5 mL at each trocar site) and 40 mL of 0.25% bupivacaine administered intraperitoneally at the end of surgery. The total dose of bupivacaine will not exceed 2 mg/kg. This technique aims to reduce postoperative somatic and visceral pain after laparoscopic hysterectomy.
干预措施: Intraperitoneal Bupivacaine spray (Drug)
结局指标
主要结局
Postoperative quality of recovery at 24 hours measured by QoR-15
时间窗: 24 hours postoperatively
The primary outcome is the overall postoperative recovery quality at 24 hours, assessed using the 15-item Quality of Recovery questionnaire (QoR-15). This scale evaluates physical comfort, emotional state, physical independence, psychological support, and pain to provide a comprehensive patient-centered measure of recovery.
次要结局
- Time to first rescue opioid requirement(From end of surgery until first rescue opioid administration (up to 24 hours))
- Total opioid consumption within 24 hours(0-24 hours postoperatively)
- Time to first mobilization(0-24 hours postoperatively)
- Postoperative pain scores (VAS)(2-24 hours postoperatively)
- Postoperative complications(0-24 hours postoperatively)
- Time to first bowel movement(0-24 hours postoperatively)
- Neutrophil-to-lymphocyte ratio (NLR)(Preoperative baseline and 24 hours postoperatively)
- Platelet-to-lymphocyte ratio (PLR)(Preoperative baseline and 24 hours postoperatively)
- Lymphocyte-to-monocyte ratio (LMR)(Preoperative baseline and 24 hours postoperatively)
- Systemic immune-inflammation index (SII)(Preoperative baseline and 24 hours postoperatively)
研究者
Aysenur Dostbil
Principal Investigator Ayşenur Dostbil
Ataturk University