Efficacy and safety of Dexmedetomidine as an adjuvant in local wound infiltration for postoperative pain relief in caesarean section: a prospective, randomized, double blinded study
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- The time at which the first analgesic is requested (rescue analgesia) in the postoperative period
研究概览
简要总结
Objective of research:
To compare the efficacy, regarding duration of postoperative analgesia, of local anaesthetic alone and local anaesthetic with dexmedetomidine, as adjuvant, in local wound infiltration in patients undergoing caesarean section.
Background of research:
Postoperative pain and opioid-related adverse drug events are still among the principal factors affecting the rapid recovery and discharge of patients undergoing surgery. It is an important concern for women undergoing caesarean section, a routine surgery in our institute. Breakthrough pain is a problem in the postoperative period leading to increased opioid consumption.
Addressing postoperative pain in caesarean section is crucial as mothers are expected to recover rapidly and care for the newborn within a few hours following surgery. Effective postperatve analgesia can enhance recovery and decrease morbidity.
Duration of analgesic can be prolonged by systemic or local route. Local wound infiltration before is a tried and tested method of improving postoperative analgesia. It is an easy, effective and affordable technique which can enhance postoperative analgesia in different types of surgeries without major complications. This technique has been shown to play an active role in relieving postoperative pain and reducing opioid consumption. Advantages are safety, simplicty and enhanced postoperative analgesia, especially during mobilisation. In recent years, procedure-specific postoperative pain (PROSPECT) Working Group has recommended wound infiltration for open abdominal surgeries.
Dexmedetomidine is a highly selective agonist of alpha-2 adrenergic receptor with sedative, analgesic but not anaesthetic characteristic, making it a safe adjuvant in various clinical settings. In various studies, dexmedetomidine as an adjucant to local anaesthetics has proven effectiveness for postoperative pain relief in various procedures including abdominal hysterectomy, knee arthroplasty.
Methodology:
This is a single centre, hospital based, double blinded, randomised controlled study on patients posted for elective caesaeran section under spinal anaesthesia, in the obstetrics operation theatre, the post-anaesthesia care unit and the post-operative ward at Midnapore Medical College & Hospital, Paschim Medinipur, over a period of 12 months. A total of 40 patients will be randomly divided into two groups where one group will receive local wound infiltration with dexmedetomidine as adjuvant and the other grouo will receive local wound infiltration with normal saline as adjuvant. The required parameters will be monitored in the monitored for upto 12 hours in the postoperative period.
Expected outcome of proposed study:
In this study we expect to find out if in reality dexmedetomidine as an adjuvant to local anaesthetic in local wound infiltrarion can provide superior pain management in terms of duration of postoperative analgesia, total dose of analgesic consumpton in 12 hours post-op, visual analog scale, the time of starting of movement, eating, breast-feeding, adverse effects of medications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 35.00 Year(s)（—）
- 性别
- Female
入选标准
- •Patients with singleton pregnancy with no obstetric complications (pre-eclampsia, antepartum haemorrhage)
- •Patients undergoing elective caesarean section
- •Patients having ASA grade II
- •Patients with normal BMI (18.
- •Patients giving valid consent.
排除标准
- •Patient refusal.
- •Patients with multiple pregancy.
- •Patients with obstetric complications (antepartum haemorrhage, pre-eclampsia).
- •Patients with history of drug abuse.
- •Patients with history of allergy to the study drug dexmedetomidine.
- •Patients with history of diabetes mellitus, heart, liver, kidney, coagulation or mental disorders.
- •Patients with communication disabilities.
结局指标
主要结局
The time at which the first analgesic is requested (rescue analgesia) in the postoperative period
时间窗: At 2, 4, 6, 8, 10 and 12 hours
次要结局
- Total dose of analgesic consumption in 12 hours in postoperative period(At 12 hours)
- Visual analog scale(At 2, 4, 6, 8, 10 and 12 hours)
- Heart rate(At 30, 60, 90, 120 minutes)
- Mean arterial pressure(At 30, 60, 90, 120 minutes)
- Nausea, vomitting(At 2, 4, 6, 8. 10 and 12 hours)
- Time of starting movement in postoperative period(At 2, 4, 6, 8, 10 and 12 hours)
- Time of starting to eat in postoperative period(At 2, 4, 6, 8, 10 and 12 hours)
- Time of initiation of breast-feeding(At 2, 4, 6, 8, 10 and 12 hours)
研究者
Dr Suman Chattopadhyay
Midnapore Medical College