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Scalp Blocks Effect on Postoperative Nausea & Vomiting After Craniotomy

A

Ain Shams University

Status

Completed

Conditions

Postoperative Nausea and Vomiting

Treatments

Other: Control Group
Procedure: Scalp block

Study type

Interventional

Funder types

Other

Identifiers

NCT04240236
R 54/2019

Details and patient eligibility

About

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

Full 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.

Enrollment

40 patients

Sex

All

Ages

18 to 50 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • ASA I and II patients,
  • aged 18 to 50 years,
  • 70-80 kg,
  • undergoing elective supratentorial craniotomy

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

40 participants in 2 patient groups, including a placebo group

Group S
Experimental group
Description:
Group S received scalp block with 20 ml of 0.5% bupivacaine
Treatment:
Procedure: Scalp block
Group C
Placebo Comparator group
Description:
Group C will not have any intervention
Treatment:
Other: Control Group

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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