Analgesic Effect of Melatonin and Vitamin C Administration, Alone or In Combination in Major Abdominal Surgery. A Randomized Double-blind Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Total morphine consumption
研究概览
简要总结
The goal of this clinical trial is to compare the analgesic effect of melatonin, and vitamin C and their combination in patients aged 18-60 years old who will undergo major abdominal surgery with mid-line incision within an expected time of surgery from 3 to 5 hours e.g. radical cystectomy, radical prostatectomy, colectomy, sigmoidectomy, splenectomy, and CBD exploration through mid-line incision.
This study hypothesizes that using both vitamin C and melatonin together as adjuvants will cause:
- More reduction in total morphine consumption in the first 24 hours postoperatively
- More reduction of the incidence of chronic post-surgical pain, than using each adjuvant alone.
Participants will be allocated into three equal groups: Melatonin (M group) and vitamin C (V group), and Melatonin and vitamin C (VM group). Two hours before surgery all patients will receive the study drugs orally and will be continued for 3 days postoperative at the same time of the first administration; 10mg of melatonin for M group (Melatonin 10 mg - Puritan's Pride premium company), 1gm of vitamin C for V group (Sanso C 1000 mg - AUG pharma company), and 10mg of melatonin and 1gm of vitamin C for VM group.
Researchers will compare:
- The effect of melatonin, vitamin C, and their combination on postoperative opioid consumption
- The severity of postoperative pain, using the Numerical Rating Scale (NRS)
- Patients' satisfaction with a three-point scale
- The time of the first requirement for rescue analgesia
- The effect on the incidence of chronic post-surgical pain.
详细描述
Randomization will be performed using computer-generated numbers with Random Allocation Software (https://random-allocation-software.software.informer.com/2.0/), in a 1:1:1 ratio. 60 consequentially numbered opaque envelopes (20 per group) will be made containing group assignments and drug administration instructions. A research assistant will be responsible for opening the envelopes and the assigned drug administration without further involvement in the study. A blinded anesthesiologist will be responsible for the anesthetic management, perioperative data collection, and postoperative pain assessment and analgesia administration.
A full history will be taken from all patients. Age, sex, height, weight, and the American Society of Anesthesiologists' (ASA) score will be recorded.
Preoperatively, patients' laboratory investigations as complete blood count, prothrombin time, concentration and INR, liver function tests, and kidney function tests will be recorded. Clinical assessment will be carried out for their eligibility for the study.
Patients will be allocated into three equal groups: Melatonin (M group) and vitamin C (V group), and Melatonin and vitamin C (VM group). Two hours before surgery all patients will receive the study drugs orally and will be continued for 3 days postoperative at the same time of the first administration [10], 10mg of melatonin for M group (Melatonin 10 mg - Puritan's Pride premium company), 1gm of vitamin C for V group (Sanso C 1000 mg - AUG pharma company), and 10mg of melatonin and 1gm of vitamin C for VM group.
The patients will attend the pre-anesthesia room one hour before the procedure, NRS pain score (Figure 1) will be explained to all candidates (zero corresponds to no pain and 10 is indicative of the worst unbearable pain).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASA I -II
- •Expected time of operation 3-5 hours
排除标准
- •BMI > 35 kg/m2
- •Presence of psychiatric or mental disorders.
- •Chronic pain syndromes (neuropathic pain, post-herpetic neuralgia, Complex regional pain syndrome)
- •Drug or alcohol abuse.
- •Hepatic failure (Child class B- Child class C)
- •Renal impairment (creatinine > 2mg/dL or CKD on regular dialysis)
- •History of any allergic reaction to the drugs used in the study.
研究组 & 干预措施
Melatonin (M group)
Two hours before surgery, patients will receive 10 mg of melatonin (Melatonin 10 mg - Puritan's Pride premium company) orally which will be continued once daily for 3 days postoperative at the same time as the first administration.
干预措施: Melatonin 10 MG (Drug)
Vitamin C (V group)
Two hours before surgery, patients will receive 1gm of vitamin C (Sanso C 1000 mg - AUG pharma company) orally which will be continued once daily for 3 days postoperative at the same time as the first administration.
干预措施: Vitamin C (Drug)
Melatonin and Vitamin C (VM group)
Two hours before surgery, patients will receive 10mg of melatonin and 1gm of vitamin C orally which will be continued once daily for 3 days postoperative at the same time as the first administration.
干预措施: Melatonin 10 MG (Drug)
Melatonin and Vitamin C (VM group)
Two hours before surgery, patients will receive 10mg of melatonin and 1gm of vitamin C orally which will be continued once daily for 3 days postoperative at the same time as the first administration.
干预措施: Vitamin C (Drug)
结局指标
主要结局
Total morphine consumption
时间窗: The 1st 24 postoperative hours
mg
次要结局
- systolic blood pressure(every 10 minutes from skin incision to skin closure and at 2, 4 hours post operatively.)
- Heart rate(every 10 minutes from skin incision to skin closure and at 2, 4 hours post operatively.)
- Time to first analgesic request(from the time of end of surgery till the first analgesic requirement during the 24 hours postoperative)
- patient satisfaction using Likert three-point scale(24 hours, 48 hours, 72 hours, 96 hours, one month and three months postoperative)
- Intra-operative mean consumption of sevoflurane per hour.(from the start of anesthesia till the end of anesthesia)
- Numeric Rating Scale(5 minutes after extubation, 30 minutes, 2 hours, 4 hours, 6 hours, 12 hours, 24 hours, 48 hours, 72 hours, 96 hours, one month and three months)
- Richmond Agitation Sedation Scale(5 minutes after extubation, 30 minutes, 2 hours, 4 hours, 6 hours, 12 hours and 24 hours)
- chronic post-surgical pain(3 months)
研究者
Amr Kamal Zahran
Associate Professor of Anesthesia, intensive care medicine and Pain therapy
Cairo University