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

NCT ID: NCT04539249

Last Updated: 2023-07-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 324 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-04
• Study Completion Date: 2021-03-31

Brief 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 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.

Conditions

Acute Post-operative Pain Following Caesarean Section

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Magnesium sulphate

Combination of intravenous magnesium sulphate, intravenous paracetamol and rectal diclofenac

Group Type: EXPERIMENTAL

Magnesium sulphate

Intervention Type: DRUG

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.

Pentazocine

Combination of intramuscular pentazocine, intravenous paracetamol and rectal diclofenac

Group Type: ACTIVE_COMPARATOR

Pentazocine

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

MgSO4

Eligibility Criteria

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.

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Olakunle Ifeoluwa Makinde

OTHER_GOV

Sponsor Role: lead

Responsible Party

Olakunle Ifeoluwa Makinde

Senior Registrar

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Olakunle I Makinde, MBChB, MWACS

Role: PRINCIPAL_INVESTIGATOR

Federal Medical Centre, Yenagoa

Locations

Federal Medical Centre, Yenagoa

Yenagoa, Bayelsa State, Nigeria

Countries

Nigeria

References

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Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

FMCY/O&G/OFAAPPCS/2020

Identifier Type: -

Identifier Source: org_study_id