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. 2019 Nov 21;2019(11):CD011931. doi: 10.1002/14651858.CD011931.pub2

Law‐Koune 2005.

Methods Study design: randomized controlled trial (3 arms)
Study duration: not reported
Study setting: hospital, single centre, France
Participants Adults undergoing elective supratentorial craniotomy for tumour resection (n = 80)
Inclusion criteria
  1. ASA I to ASA III participants undergoing elective supratentorial craniotomy for tumour resection


Exclusion criteria
  1. Inability to understand the visual analogue scale

  2. Previous scalp incision

  3. Intracranial hypertension

  4. Cerebrovascular disease

  5. Allergy to any study drug

  6. Regular opioid usage

  7. Surgery scheduled to start after 2 pm


Mean age, range (years)
  1. 49 (18 to 80)


Numbers allocated to each arm
  1. Group 1: scalp infiltration with either 0.375% bupivacaine with 1:200,000 epinephrine (n = 20)

  2. Group 2: scalp infiltration with 0.75% ropivacaine (n = 20)

  3. Group 3: scalp infiltration with 20 mL of saline (n = 40)


Male gender
  1. Group 1: 8/20 (analysed patients)

  2. Group 2: 8/19 (analysed patients)

  3. Group 3: 16/37 (analysed patients)

Interventions Technique and timing
  1. Scalp infiltration with 0.375% bupivacaine with epinephrine 1:200,000 versus scalp infiltration with 0.75% ropivacaine versus scalp infiltration with saline with epinephrine 1:200,000, before scalp closure


Dosage
20 mL
Outcomes Primary
  1. Total morphine requirement during the first 16 hours postoperatively


Secondary
  1. Pain as measured by the visual analogue scale

  2. Sedation score: from ‘alert’ to ‘roused only by shaking': 1 to 5

  3. Adverse events: nausea, vomiting, pruritis, urinary retention, need for antihypertensive medication, haematoma

Notes Funding
No funding source reported
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk A table of random numbers was used for randomization
Allocation concealment (selection bias) High risk Authors did not provide any details regarding how the allocation sequence was concealed.
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk Quote: ''the anaesthesiologist, surgeon, and patient were blinded to the solution''. However no details were provided regaining the method used or how or if its adequacy was assessed.
Blinding of outcome assessment (detection bias) 
 All outcomes High risk No details were provided as to whether or not those assessing outcomes were blinded to treatments received.
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk 4 participants were excluded from the final analysis due to postoperative complications:
3 in the control group (2 due to unspecified neurological complications and 1 due to excessive sedation)
1 in the ropivacaine group (due to an unspecified neurological complication)
The lack of an intention‐to‐treat analysis made the effect of their exclusion difficult to determine.
Selective reporting (reporting bias) Low risk Outcomes were reported as specified.
Other bias Unclear risk Small study