Single-centre, Randomized, Clinical Trial of Opioid-free Analgesia Versus Routine Opioid-based Analgesia Regimen for the Management of Acute Post-operative Pain Following Caesarean Section
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 324
- 试验地点
- 1
- 主要终点
- Post-operative Pain Scores Following Caesarean Section at 8 Hours Post-operative
研究概览
简要总结
Background: Multimodal analgesia; a combination of opioid and non-opioid analgesics, for management of acute post-operative pain significantly reduces the incidence of adverse effects associated with liberal post-operative opioid use including sedation, respiratory depression, constipation, ileus, urinary retention, delayed recovery, addiction etc. However, opioid addiction remains a worsening public health problem and have followed administration of opioid analgesics for post-operative pain and subsequent chronic use in many addicts; especially the opioid naive. Caesarean section is a commonly performed surgery and is a common source of first exposure to opioids in women. Trend in post-operative analgesia is moving towards opioid-free (multimodal) analgesia; a combination of non-opioid and adjuvant analgesics. Magnesium sulphate is an adjuvant analgesic. When administered peri-operatively, it has been reported to prolong the duration of spinal anaesthesia, decrease post-operative pain and opioid use without adverse effect.
Aim: To determine the effectiveness and safety of a combination of peri-operative intravenous magnesium sulphate, intravenous paracetamol, and post-operative rectal diclofenac as opioid-free, multimodal analgesia for management of acute post-operative pain after a caesarean section.
Null Hypothesis: Combination of intravenous magnesium sulphate, intravenous paracetamol, and rectal diclofenac as analgesia regimen for acute post-operative pain after a caesarean section is not as effective and safe as a routine opioid-based multimodal analgesia regimen used in the study setting.
Alternate Hypothesis: Combination of intravenous magnesium sulphate, intravenous paracetamol, and rectal diclofenac as analgesia regimen for acute post-operative pain after a caesarean section is as effective and safe as a routine opioid-based multimodal analgesia regimen used in the study setting.
Materials and Methods: A randomized clinical trial, comparing a combination of peri-operative intravenous magnesium sulphate, intravenous paracetamol, and post-operative rectal diclofenac with an opioid-based multimodal regimen as control. Eligible patients will be consecutively selected from among women booked for caesarean section at the Federal Medical Centre, Yenagoa. Control group will receive a combination of post-operative intramuscular pentazocine, intravenous paracetamol and rectal diclofenac. Pain intensity will be determined in both groups and compared. Need for rescue opioid analgesic will be determined in both groups and compared. Incidence of any adverse event in both groups will be determined.
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
- Single (Outcomes Assessor)
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant women booked for elective, scheduled and urgent caesarean section at the Federal Medical Centre, Yenagoa, Bayelsa State during the study period,
- •Pregnant women who give consent to participate in the study.
排除标准
- •Pregnant women with active peptic ulcer disease, active liver disease, hepatic failure, and renal failure,
- •Pregnant women with previous history of ischaemic heart disease/myocardial infarction, heart failure, venous thrombosis and stroke,
- •Hypersensitivity to pentazocine, paracetamol, diclofenac or magnesium sulphate,
- •Pregnant women with history of non-medical use (abuse) of opioids,
- •Pregnant women on magnesium sulphate or have a clinical indication to receive magnesium sulphate,
- •Pregnant women booked for emergency caesarean section (because the urgency may not allow time for adequate patient counseling before recruitment)
- •Pregnant women booked for caesarean section under general anaesthesia or epidural anaesthesia,
- •Pregnant women who can neither communicate in english nor colloquial english.
研究组 & 干预措施
Magnesium sulphate
Combination of intravenous magnesium sulphate, intravenous paracetamol and rectal diclofenac
干预措施: Magnesium sulphate (Drug)
Pentazocine
Combination of intramuscular pentazocine, intravenous paracetamol and rectal diclofenac
干预措施: Pentazocine (Drug)
结局指标
主要结局
Post-operative Pain Scores Following Caesarean Section at 8 Hours Post-operative
时间窗: 8 hours post-operative
Post-operative pain scores following caesarean section at 8 hours post-operative using the Numerical Rating Scale for pain. The Numerical Rating Scale for pain has a minimum score of 0, a maximum score of 10 and a range of 0-10, where higher scores mean a worse outcome (0= No pain at all, 5= Moderate pain and 10= Worst pain imaginable)
Post-operative Pain Scores Following Caesarean Section at 24 Hours Post-operative
时间窗: 24 hours post-operative
Post-operative pain scores following caesarean section at 24 hours post-operative using the Numerical Rating Scale for pain. The Numerical Rating Scale for pain has a minimum score of 0, a maximum score of 10 and a range of 0-10, where higher scores mean a worse outcome (0= No pain at all, 5= Moderate pain and 10= Worst pain imaginable)
Post-operative Pentazocine Use
时间窗: 24 hours post-operative
Whether or not Pentazocine was used post-operatively
Pentazocine Use as Rescue Analgesia
时间窗: 24 hours post-operative
Whether or not pentazocine was used as rescue analgesia
Frequency and Nature of Pentazocine Use
时间窗: 24 hours post-operative
Frequency of Pentazocine use per participant in each arm of the study and whether it was used as indicated in the protocol and/or for rescue analgesia
Mean Dose of Pentazocine Used
时间窗: 24 hours post-operative
Mean dose of Pentazocine used in each arm of the study
Post-operative Pain Scores Following Caesarean Section at 4 Hours Post-operative
时间窗: 4 hours post-operative
Post-operative pain scores following caesarean section at 4 hours post-operative using the Numerical Rating Scale for pain. The Numerical Rating Scale for pain has a minimum score of 0, a maximum score of 10 and a range of 0-10, where higher scores mean a worse outcome (0= No pain at all, 5= Moderate pain and 10= Worst pain imaginable)
次要结局
- Number of Participants With Post-operative Adverse Events(First 24 hours post-operative)
- Number of Participants With Peri-operative Adverse Events(Time of first administration of peri-operative analgesia to 2 hours postoperative)
- Apgar Scores of the Neonates(At first and fifth minutes after birth)
研究者
Olakunle Ifeoluwa Makinde
Senior Registrar
Federal Medical Centre, Yenagoa