Opioid-free Analgesia for the Management of Acute Post-operative Pain Following Caesarean Section

• Status: Completed
• Trial end date: 2021-03-31
• Target enrollment: 0
• Participant gender: Female

Summary

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 of a combination of intravenous magnesium sulphate, intravenous paracetamol, and rectal diclofenac as opioid-free 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 analgesic regimen for acute post-operative pain after a caesarean section is not as effective as the standard opioid-based multimodal analgesia regimen used at Federal Medical Centre, Yenagoa.

Alternate Hypothesis: Combination of intravenous magnesium sulphate, intravenous paracetamol, and rectal diclofenac as analgesic regimen for acute post-operative pain after a caesarean section is as effective as the standard opioid-based multimodal analgesia regimen used at Federal Medical Centre, Yenagoa.

Materials and Methods: A randomized clinical trial, comparing a combination of intravenous magnesium sulphate, intravenous paracetamol, and 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 intramuscular pentazocine, intravenous paracetamol and rectal diclofenac. Pain intensity will be determined in both groups and compared. Need for rescue opioid in the opioid-free analgesia treated patients and incidence of any adverse event in both groups will be determined.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Olakunle Ifeoluwa Makinde
• Treatments: Magnesium Sulfate; Pentazocine

Criteria

Inclusion Criteria:

• Pregnant women booked for caesarean section at the Federal Medical Centre, Yenagoa who gives consent to participate in the study.

Exclusion Criteria:

• 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 decline to participate in the study,

• Pregnant women who can neither communicate in english nor colloquial english.