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

August 27, 2022 updated by: Olakunle Ifeoluwa Makinde

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

324

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Nigeria
    • Bayelsa State
      • Yenagoa, Bayelsa State, Nigeria, 560231
        • Federal Medical Centre, Yenagoa

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Magnesium sulphate
Combination of intravenous magnesium sulphate, intravenous paracetamol and rectal diclofenac
Drug: Magnesium sulphate

1g of paracetamol as an I.V infusion and 4g of magnesium sulphate as an I.V. bolus preoperatively. Continuous infusion of 1g/hr of magnesium sulphate intraoperatively and for the first 2 hours post-operatively. Further post-operatively, 100 mg of suppository diclofenac 12 hourly, intravenous paracetamol 1g 6 hourly, both over 24 hours.

N.B: Intramuscular pentazocine 30 mg (45 mg if patient is > 70 kg) will be used as rescue analgesia as needed (that is, only on patients' request for further analgesia or following an assessment of moderate to severe pain despite the planned analgesic regimen) at least 4 hourly during the first 24 hours after caesarean section.

Other Names:
  • MgSO4
Active Comparator: Pentazocine
Combination of intramuscular pentazocine, intravenous paracetamol and rectal diclofenac
Drug: Pentazocine

Post-operatively, suppository diclofenac 100mg 12 hourly, intramuscular pentazocine 30 mg (45 mg if patient is > 70 kg) 6 hourly, intravenous paracetamol 1g 6 hourly, all for 24 hours.

N.B: Intramuscular pentazocine 30 mg (45 mg if patient is > 70 kg) will be used as rescue analgesia as needed (that is, only on patients' request for further analgesia or following an assessment of moderate to severe pain despite the planned analgesic regimen) at least 4 hourly during the first 24 hours after caesarean section.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-operative Pain Scores Following Caesarean Section at 4 Hours Post-operative
Time Frame: 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)
4 hours post-operative
Post-operative Pain Scores Following Caesarean Section at 8 Hours Post-operative
Time Frame: 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)
8 hours post-operative
Post-operative Pain Scores Following Caesarean Section at 24 Hours Post-operative
Time Frame: 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)
24 hours post-operative
Post-operative Pentazocine Use
Time Frame: 24 hours post-operative
Whether or not Pentazocine was used post-operatively
24 hours post-operative
Pentazocine Use as Rescue Analgesia
Time Frame: 24 hours post-operative
Whether or not pentazocine was used as rescue analgesia
24 hours post-operative
Frequency and Nature of Pentazocine Use
Time Frame: 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
24 hours post-operative
Mean Dose of Pentazocine Used
Time Frame: 24 hours post-operative
Mean dose of Pentazocine used in each arm of the study
24 hours post-operative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Peri-operative Adverse Events
Time Frame: Time of first administration of peri-operative analgesia to 2 hours postoperative
Number of participants with peri-operative adverse events including hypersensitivity reaction, respiratory depression, bradycardia, hypotension, nausea and vomiting, lightheadedness, presyncope, and any other adverse event recorded from the time of first administration of peri-operative analgesia to 2 hours postoperative
Time of first administration of peri-operative analgesia to 2 hours postoperative
Number of Participants With Post-operative Adverse Events
Time Frame: First 24 hours post-operative
Number of participants with post-operative adverse events including respiratory depression constipation, ileus, pruritus, urinary retention and any other adverse event recorded during the first 24 hours post-operative.
First 24 hours post-operative
Apgar Scores of the Neonates
Time Frame: At first and fifth minutes after birth
Apgar scores of the neonates delivered by the women who had caesarean section under the study, taken at first and fifth minutes after birth. Apgar score has a minimum score of 0, a maximum score of 10 and a range of 0-10, where higher scores mean a better outcome (0-3= low Apgar score, 4-6= moderately abnormal Apgar score and 7-10= reassuring Apgar score
At first and fifth minutes after birth

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Olakunle Ifeoluwa Makinde

Investigators

  • Principal Investigator: Olakunle I Makinde, MBChB, MWACS, Federal Medical Centre, Yenagoa

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 4, 2020

Primary Completion (Actual)

March 30, 2021

Study Completion (Actual)

March 31, 2021

Study Registration Dates

First Submitted

August 30, 2020

First Submitted That Met QC Criteria

September 3, 2020

First Posted (Actual)

September 4, 2020

Study Record Updates

Last Update Posted (Actual)

July 20, 2023

Last Update Submitted That Met QC Criteria

August 27, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FMCY/O&G/OFAAPPCS/2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All Individual Participant Data that underlie results in a publication

IPD Sharing Time Frame

Starting 3 months after publication

IPD Sharing Access Criteria

Open access

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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