Opioid-free Analgesia for the Management of Acute Post-operative Pain Following Caesarean Section
Status:
Completed
Trial end date:
2021-03-31
Target enrollment:
Participant gender:
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.