Intrathecal Morphine for Quality of Recovery After Open Abdominal Surgery Within an Enhanced Recovery Pathway: A Prospective, Multicenter, Randomized, Placebo-Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 756
研究概览
简要总结
Pain management after open abdominal surgery still faces severe challenges, with the incidence of moderate to severe pain after surgery as high as 50 - 90%. Insufficient analgesia can hinder early mobilization of patients, delay gastrointestinal function recovery, increase the risk of complications, thereby reducing the quality of patient recovery and prolonging hospital stay.
The Enhanced Recovery after Surgery (ERAS) pathway has significantly improved surgical outcomes. Multimodal analgesia based on transversus abdominis plane block (TAPB) analgesia is the core of ERAS for abdominal surgery. However, the existing multimodal analgesia regimens still inade-quately control visceral pain, resulting in the failure to significantly reduce the dosage of opioid drugs, which has become a key bottleneck restricting the smooth recovery of patients.
Intrathecal morphine (ITM) directly delivers the drug to the dorsal horn of the spinal cord through cerebrospinal fluid, providing potent and long-lasting visceral analgesia. Although its analgesic effect is clear, in the context of modern ERAS with routine application of TAPB, there is still insufficient evidence regarding the impact of ITM on the quality of recovery - a multi-dimensional core outcome - in patients undergoing open abdominal surgery. In addition, whether its effect is affected by key factors such as age (e.g., >60 years) or surgical site (upper abdomen vs. lower abdomen) also remains to be clarified.
Therefore, in this prospective, multicenter, randomized, double-blind, placebo-controlled trial, we aimed to evaluate whether single-dose preoperative ITM can further improve the quality of recovery in the ERAS pathway based on TAPB and to verify the efficacy differences of ITM in important subgroups.
详细描述
Pain management after open abdominal surgery still faces severe challenges, with the incidence of moderate to severe pain after surgery as high as 50 - 90%. Insufficient analgesia can hinder early mobilization of patients, delay gastrointestinal function recovery, increase the risk of complications, thereby reducing the quality of patient recovery and prolonging hospital stay.
The Enhanced Recovery after Surgery (ERAS) pathway has significantly improved surgical outcomes. Multimodal analgesia based on transversus abdominis plane block (TAPB) analgesia is the core of ERAS for abdominal surgery. However, the existing multimodal analgesia regimens still inadequately control visceral pain, resulting in the failure to significantly reduce the dosage of opioid drugs, which has become a key bottleneck restricting the smooth recovery of patients.
Intrathecal morphine (ITM) directly delivers the drug to the dorsal horn of the spinal cord through cerebrospinal fluid, providing potent and long-lasting visceral analgesia. Although its analgesic effect is clear, in the context of modern ERAS with routine application of TAPB, there is still insufficient evidence regarding the impact of ITM on the quality of recovery - a multi-dimensional core outcome - in patients undergoing open abdominal surgery. In addition, whether its effect is affected by key factors such as age (e.g., >60 years) or surgical site (upper abdomen vs. lower abdomen) also remains to be clarified.
Therefore, in this prospective, multicenter, randomized, double-blind, placebo-controlled trial, we aimed to evaluate whether single-dose preoperative ITM can further improve the quality of recovery in the ERAS pathway based on TAPB and to verify the efficacy differences of ITM in important subgroups.
The anesthesia scheme was endotracheal intubation general anesthesia combined with bupivacaine liposome plane block of transverse abdominal muscle, experimental group combined with intrathecal morphine, control group injected with intrathecal saline. After the patient enters the operating room, establish an intravenous access in the healthy upper limb and perform standard monitoring (electrocardiogram, non-invasive blood pressure, and oxygen saturation). Before lumbar puncture, intravenous infusion of dexmedetomidine 30 μg is given for conscious sedation, and then the patient takes a lateral position for ultrasound-guided lumbar puncture. Inject the drug labeled "Study drug for intrathecal injection" of 5ml.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The research coordinator of this center will log in to the password-protected randomization website 1 hour before the operation to obtain the random number (experimental group or control group) of the next research patient. The research coordinator will prepare the study drugs under aseptic conditions according to the random grouping and will no longer participate in the research.
Experimental group (intrathecal morphine): The drug used for intrathecal injection was morphine of 3ug/kg diluted to 5ml . It was drawn into a 5-ml syringe and labeled with "Study drug for intrathecal use".
Control group (placebo): The drug used for intrathecal injection was NS 5ml . It was drawn into a 5-ml syringe and labeled with "Study drug for intrathecal use".
The drugs in both syringes will be placed in the spinal anesthesia tray in a sterile manner and admin-istered intrathecally by the anesthesiologist.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years.
- •Scheduled for elective open abdominal surgery (upper or lower abdomen).
- •American Society of Anesthesiologists classification I-III.
- •Signed informed consent form.
排除标准
- •Allergic to opioids or any drug in the trial.
- •Presence of contraindications to intrathecal injection (such as abnormal coagulation function, puncture site infection, increased intracranial pressure).
- •History of chronic pain, long-term use of opioids.
- •Severe hepatic and renal insufficiency (Child-Pugh C grade or eGFR < 30 mL/min).
- •Severe respiratory diseases (such as non-invasive ventilation required for sleep apnea syndrome).
- •Cognitive dysfunction, unable to complete the questionnaire.
- •Pregnant or lactating women.
- •Withdrawal criteria:
- •The patient or legal representative requests withdrawal.
- •Serious complications occur during the study, and continued participation is not in the best in-terest of the patient.
- •Other situations where the researcher believes withdrawal is necessary.
研究者
RenChun Lai
Clinical Professor
Sun Yat-sen University