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

Bala 2006.

Methods Study design: randomized controlled trial (2 arms)
Study duration: not reported
Study setting: hospital, single centre, India
Participants Adult patients undergoing elective supratentorial craniotomy for brain tumours (n = 40)
Inclusion criteria
  1. ASA I to ASA II


Exclusion criteria
  1. Decreased level of consciousness

  2. Allergy to bupivacaine

  3. Undergoing emergency surgery


Mean age, range (years)
  1. 34 (18 to 50)


Numbers allocated to each arm
  1. Group intervention (n = 20)

  2. Group control (n = 20)


Male gender
  1. Group intervention: 10/20

  2. Group control: 15/20

Interventions Technique and timing
Scalp block of the following nerves with 0.5% bupivacaine and adrenaline 1:400,000 adrenaline
  1. Supraorbital and supratrochlear

  2. Zygomaticotemporal

  3. Auriculotemporal

  4. Postauricular branches of the greater auricular

  5. Greater, lesser, and third occipital nerves


versus scalp block, with saline and adrenaline 1:400,000, at the end of surgery
Dosage
20 mL
Outcomes Primary
  1. Pain as measured by the NRS (numerical pain rating scale) in the first 12 hours postoperatively (measured at 30 minutes, 1, 2, 4, 6, 8 and 12 hours)


Secondary
  1. Total amount of rescue analgesia required

  2. Time to requirement of rescue analgesia

  3. Blood pressure, heart rate and respiratory rate

  4. Sedation Score using a 4‐point scale

  5. GCS (Glasgow Coma Scale)

Notes Funding
No funding source reported
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: ''patients were randomly divided into two groups using a computer generated random number chart''.
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 Low risk Quote: ''the neurosurgeon, the anaesthetist performing the scalp block and the patients were blinded to the drug being administered''.
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Quote: ''the anaesthetist performing the block did not participate in the postoperative pain assessment''.
Incomplete outcome data (attrition bias) 
 All outcomes Low risk All enrolled participants were followed up for outcomes.
Selective reporting (reporting bias) Low risk Outcomes reported as specified
Other bias Unclear risk Small study