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Scalp Blocks Effect on Postoperative Nausea & Vomiting After Craniotomy

Not Applicable
Completed
Conditions
Postoperative Nausea and Vomiting
Interventions
Procedure: Scalp block
Other: Control Group
Registration Number
NCT04240236
Lead Sponsor
Ain Shams University
Brief Summary

In this study, the investigators hypothesize that preemptive scalp block in neurosurgical patients may decrease incidence of PONV after craniotomy through decreasing intraoperative inhalational agents' concentration and decreasing intraoperative opioids requirements, with better intraoperative hemodynamics and lesser recovery time

Detailed Description

Patients will be recruited after admission to the hospital for surgery. Randomization will be performed using computer-generated random number tables in opaque sealed envelopes prepared by an anesthesiologist who will be not part of the study

Patients will be randomly divided into two groups using a computer generated random number chart. Group S received scalp block with 20 ml of 0.5% bupivacaine, whereas Group C received scalp block using 20 mL normal saline and will be considered as control group.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
40
Inclusion Criteria
  • ASA I and II patients,
  • aged 18 to 50 years,
  • 70-80 kg,
  • undergoing elective supratentorial craniotomy
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Exclusion Criteria
  • patients under 18 years of age,
  • pregnancy,
  • emergency surgery,
  • patients with a Glasgow Coma Score (GCS) less than 15,
  • those with documented allergy to bupivacaine,
  • regular communication not possible,
  • Patients requiring prolonged mechanical ventilation (> 2 hours after end of surgery) will be also excluded
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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Group SScalp blockGroup S received scalp block with 20 ml of 0.5% bupivacaine
Group CControl GroupGroup C will not have any intervention
Primary Outcome Measures
NameTimeMethod
PONV incidence & severity during the 1st 24 hours in ICU.24 hours

The intensity of the PONV was classified as: 0: without PONV, 1: nausea, 2: vomiting and 3: vomiting more than 2 times \[8\]. In addition, the incidence of PONV, the first time there was need for ondansetron and its total dose was recorded. With PONV score ≥ 2, the investigators used 4 mg ondansetron IV for antiemetic regimen. The total dose over 24 hours (given as divided doses) must not exceed adult dose of 32 mg.

Secondary Outcome Measures
NameTimeMethod
Total intraoperative fentanyl consumption in microgram6 hours

The bolus dose given at skin incision was not included

Recovery time in minutes10 minutes

It is the time interval between discontinuation of isoflurane and extubation

Intraoperative Mean blood pressure in mmHg6 hours

Mean blood pressure will be measured at specific timing coded as follows: Tzero: mean blood pressure will be measured preoperatively as baseline T1: mean blood pressure will be measured after intubation T2: mean blood pressure will be measured after scalp block T3: mean blood pressure will be measured during pinning T4: mean blood pressure will be measured at skin incision Then mean blood pressure will be measured every 15 min for 1 hour, and every 1 hour till end of surgery T-end: mean blood pressure will be measured at skin closure

Intraoperative Heart rate as number of beats per minute6 hours

Heart rate will be measured at specific timing coded as follows: Tzero: Heart rate will be measured preoperatively as baseline T1: Heart rate will be measured after intubation T2: Heart rate will be measured after scalp block T3: Heart rate will be measured during pinning T4: Heart rate will be measured at skin incision Then Heart rate will be measured every 15 min for 1 hour, and every 1 hour till end of surgery T-end: Heart rate will be measured at skin closure

Trial Locations

Locations (1)

Raham Hasan

🇪🇬

Cairo, Egypt

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