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

Olakunle Ifeoluwa Makinde

Status

Completed

Conditions

Acute Post-operative Pain Following Caesarean Section

Treatments

Drug: Pentazocine

Drug: Magnesium sulphate

Study type

Interventional

Funder types

Other

Identifiers

NCT04539249

FMCY/O&G/OFAAPPCS/2020

Details and patient eligibility

About

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.

Enrollment

324 patients

Sex

Female

Volunteers

No Healthy Volunteers

Inclusion criteria

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.

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 can neither communicate in english nor colloquial english.