Assessment of the Analgesic Efficacy of Morphine Chloride in Addition to a Low Dose Solution of Spinal Anaesthetic in Hemorrhoidectomy Compared to a Standard Dose of Spinal Local Anaesthetic. Simple Blind, Randomized, With Blinded Evaluation by Third Parties Clinical Trial.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 63
- 试验地点
- 2
- 主要终点
- Measurement of the Analgesic Effect After Surgery by VAS From 0 to 10, Where 0 is no Pain and 10 is the Worst Pain Imaginable.
研究概览
简要总结
A single blind, randomized, with blinded evaluation by third parties clinical trial is carried out to assess the analgesic efficay of the addition of morphine chloride to a low dose solution of spinal local anaesthetic compared to a standard dose spinal anaesthetic in the haemorrhoid surgery.
The objective of this clinical trial is to assess if the experimental treatment is as efficacy as the standard treatment in the anesthetic and analgesic effects with less side effects, greater and earlier mobility after surgery and shortened the hospitalization.
详细描述
DESIGN OF THE TRIAL:
A multicentre, randomized, single-blind, with masked evaluationby third parties clinical trial.
The Clinical Pharmacology Unit will perform a permuted blocks randomization scheme for each of the two hospitals participating in the trial. The result of this randomization will be kept in this unit and will not be accessible to investigators. Investigators will receive a series of opaque sealed envelopes with a number corresponding to the order of entry of the patients into the trial. When the patient is in the operating room, investigators must open the envelope which contains the group of treatment assigned to that patient. The patient will not know in which intervention group is included. Investigator who performs the spinal puncture and investigator who collects the data and performs the evaluation will no be the same person. This will allow a blind evaluation.
OBJECTIVES:
Main objective:
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)
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing hemorrhoidectomy.
- •Age between 18 and
- •Both gender
- •ASA I to III.
- •With indication for spinal block.
- •People capable to grant the informed consent.
排除标准
- •Patients with allergies to the study drugs.
- •Patients with any contraindication for performing a spinal technique (coagulation disorders, fever, intracraneal hypertension, abscess in the puncture site, etc..).
- •Patients with previous neurological disorders.
- •Pregnant women.
- •Women who may be pregnant and do not have a negative pregnancy test.
- •Breastfeeding women.
- •Patients with uncapable to give informed consent.
研究组 & 干预措施
Bupivacaine + Morphine Chloride
People in this arm will receive treatment with morphine chloride in addition to a low dose solution of the local intradural anaesthetic bupivacaine.
干预措施: Bupivacaine low dose (Drug)
Bupivacaine + Morphine Chloride
People in this arm will receive treatment with morphine chloride in addition to a low dose solution of the local intradural anaesthetic bupivacaine.
干预措施: Morphine Chloride (Drug)
Bupivacaine standard dose
People in this arm will receive treatment with the standard dose of the local intradural anaesthetic bupivacaine
干预措施: Bupivacaine standard dose (Drug)
结局指标
主要结局
Measurement of the Analgesic Effect After Surgery by VAS From 0 to 10, Where 0 is no Pain and 10 is the Worst Pain Imaginable.
时间窗: Up to 72 hours from the end of the surgery in the hospital stay and during the next 7 days at home, after discharge
To compare whether the addition of morphine chloride to a low dose solution of bupivacaine and improves the analgesic treatment than a single administration of bupivacaine.
Measurement of Time to Start the Anaesthetic Effect
时间窗: First 20 minutes between administration and beginning of surgery
To compare whether the addition of morphine chloride to a low dose intradural solution of the local anaesthetic bupivacaine is as effective as an administration of a single dose of bupivacaine.
次要结局
- Greater and Earlier Mobilization Measured by Bromage Scale.(During the first 24 hours after surgery and at the entry and exit of the resuscitation unit)
- Number of Adverse Events(Up to 72 hours from the intervention and the hopitalary stay and during the next 7 days after discharge)
- Time of Hospitalization(Up to 72 hours after the intervention)