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. 2018 Dec 3;2018(12):CD012624. doi: 10.1002/14651858.CD012624.pub2

Mansfield 1996.

Methods Study design: parallel‐group randomized controlled trial
Sample size: 66
Country: UK
Setting: secondary care hospital
Dates conducted: not reported
Postoperative opioid used and delivery: PCA morphine
Pain score collection: not reported
Concurrent postoperative analgesics: none reported in first 24 hours
Participants Inclusion criteria
  1. Females undergoing total abdominal hysterectomy with or without salpingo‐oopherectomy

  2. ASA 1 or 2

  3. Aged 18 to 70 years

  4. Weighing 45 kg to 100 kg


Exclusion criteria
  1. If individual requested exclusion

  2. Organ dysfunction

  3. Chronic pain

  4. Regular opioids

  5. NSAIDs

  6. Drug/alcohol abuse

  7. Psychiatric disorder

Interventions Group Pre‐low (22 participants): intravenous morphine 0.15 mg/kg given during induction and placebo at peritoneal closure
Group Pre‐high (20 participants): intravenous morphine 0.3 mg/kg given during induction and placebo at peritoneal closure
Group Post (18 participants): placebo at induction and 0.15 mg/kg at peritoneal closure
Outcomes
  1. Postoperative pain (1, 2, 4, 24, and 48 hours on 0‐to‐100‐millimetre VAS and 0‐to‐8 VRS at rest and movement)

  2. Morphine consumption (mg at 24 and 48 hours)

  3. Nausea, vomiting, and antiemetic requirement (all yes/no at 24 hours)

Notes Funding: not reported
Declarations of interest: not reported
Authors contacted: we contacted authors for further information but received no response.
Other: results reported as median so included in narrative synthesis. Pain data extracted from graph using computer software.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk No details
Allocation concealment (selection bias) Low risk Pharmacy controlled. Quote: "pharmacy prepared 10ml colourless solutions which were sequentially numbered"
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk Double‐dummy used. Quote: "pharmacy prepared 10ml colourless solutions which were sequentially numbered"
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Blinded based on above information. Quote: "all investigators were blinded to the contents of the pair of ampoules"
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Dropouts unlikely to bias results. 1 participant from 1 group excluded due to severe anxiety, but number too small to affect results.
Selective reporting (reporting bias) Unclear risk No protocol or trial registration
Other bias Low risk Similar baseline characteristics