Ignite Creation Date:
2024-05-06 @ 3:08 PM
Last Modification Date:
2024-10-26 @ 1:44 PM
Study NCT ID:
NCT04539249
Status:
COMPLETED
Last Update Posted:
2023-07-20
First Post:
2020-08-30
Brief Title:
Opioid-free Analgesia for the Management of Acute Post-operative Pain Following Caesarean Section
Sponsor:
Olakunle Ifeoluwa Makinde
Organization:
Federal Medical Centre Yenagoa
Study Overview
Official Title:
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
Status:
COMPLETED
Status Verified Date:
2022-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
OFAAPPCS
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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None