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

Use of Opioid-free Analgesia for the Management of Acute Post-operative Pain Following Caesarean Section: a Randomized Clinical Trial

Sponsors

Lead Sponsor: Olakunle Ifeoluwa Makinde

Source Federal Medical Centre, Yenagoa
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 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.

Overall Status Enrolling by invitation
Start Date October 2020
Completion Date December 2020
Primary Completion Date December 2020
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Post-operative pain scores following caesarean section at 4 hours post-operative 4 hours post-operative
Post-operative pain scores following caesarean section at 8 hours post-operative 8 hours post-operative
Post-operative pain scores following caesarean section at 24 hours post-operative 24 hours post-operative
Post-operative pentazocine use and dose used First 24 hours post-operative
Secondary Outcome
Measure Time Frame
Incidence of preoperative, intraoperative and post-operative adverse events First 48 hours post-operative
Enrollment 100
Condition
Intervention

Intervention Type: Drug

Intervention Name: Magnesium sulphate

Description: 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 only as rescue analgesia as needed (that is, only on patients' request for further analgesia or following an assessment of moderate to severe pain despite non-opioid analgesia) at least 4 hourly during the first 24 hours after caesarean section.

Arm Group Label: Magnesium sulphate

Other Name: MgSO4

Intervention Type: Drug

Intervention Name: Pentazocine

Description: 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.

Arm Group Label: Pentazocine

Eligibility

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.

Gender: Female

Gender Based: Yes

Minimum Age: N/A

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Olakunle I Makinde, MBChB, MWACS Principal Investigator Federal Medical Centre, Yenagoa
Location
Facility: Federal Medical Centre, Yenagoa
Location Countries

Nigeria

Verification Date

September 2020

Responsible Party

Type: Sponsor-Investigator

Investigator Affiliation: Federal Medical Centre, Yenagoa

Investigator Full Name: Olakunle Ifeoluwa Makinde

Investigator Title: Senior Registrar

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Magnesium sulphate

Type: Experimental

Description: Combination of intravenous magnesium sulphate, intravenous paracetamol and rectal diclofenac

Label: Pentazocine

Type: Active Comparator

Description: Combination of intramuscular pentazocine, intravenous paracetamol and rectal diclofenac

Acronym OFAAPPCS
Patient Data Yes
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Supportive Care

Masking: Single (Outcomes Assessor)

Source: ClinicalTrials.gov