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. 2021 May 18;2021(5):CD007579. doi: 10.1002/14651858.CD007579.pub3

Ibrahim 2019.

Study characteristics
Methods RCT
Participants Inclusion criteria:
  • Women undergoing elective cesarean delivery under spinal anaesthesia

  • ASA physical status I‐II

  • N = 80 women randomised, 77 analysed


Exclusion criteria:
  • Women with infection at the site of injection, coagulopathy or other bleeding diathesis, pre‐existing neurologic deficits, history of hypersensitivity to any of the given drugs, inability to communicate with the investigator and history of chronic opioid use.

Interventions Intervention: opioid antagonist (Comparison 7)
  • Nalbuphine 0.5 mg

  • Women received IT nalbuphine (0.5 mg) alongside anaesthetic (IT 10 mg of 0.5% hyperbaric bupivacaine with 0.2 mg morphine) in 0.5 mLvolume with total volume 2.5 mL.)

  • N = 40 women randomised to this group but 1 excluded (for PPH and needing surgical intervention) – so 39 in analysis


Comparator: placebo
  • IT 10 mg of 0.5% hyperbaric bupivacaine with 0.2 mg morphine) in 0.5 mLvolume with total volume 2.5 mL

  • N = 40 women randomised to this group but 2 excluded (1 for PPH and needing surgical intervention, 1 for sensory block failed) – so 38 in analysis


Both groups received bupivacaine and morphine as part of the spinal anaesthesia
Outcomes Nausea and vomiting
Notes Setting: Womens Health Hospital, Assiut University, Faculty of Medicine, Egypt
Dates: July 2016 ‐ August 2017
Funding source: not reported in English translation of abstract
Declaration of interest: not reported
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "...computer generated..."
Allocation concealment (selection bias) Unclear risk Quote: "... placed in a sealed envelope prior to study initiation...." but no mention of envelopes being opaque or serially numbered
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk As above
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk As above
Incomplete outcome data (attrition bias)
All outcomes Low risk 3/80 (4%) of women were excluded after randomisation
Selective reporting (reporting bias) High risk Methods say they will report itching, hypotension, bradycardia but these outcomes not reported. Paracetamol use reported but not listed in outcomes
Other bias Unclear risk Baseline data similar but unclear of there may be other biases