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NCT Number: NCT04240236

Scalp Blocks Effect on Postoperative Nausea & Vomiting After Craniotomy

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

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Key information

Conditions

Postoperative Nausea and Vomiting Nausea Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms Signs and Symptoms, Digestive Vomiting

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Raham Hasan

Cairo, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Scalp block

Procedure

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 will not receive any intervention and will be considered as control group.

Control Group

Other

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 will not receive any intervention and will be considered as control group.

Primary outcomes

  1. PONV incidence & severity during the 1st 24 hours in ICU.

    Time frame: 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 outcomes

  1. Intraoperative Mean blood pressure in mmHg

    Time frame: 6 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

  2. Total intraoperative fentanyl consumption in microgram

    Time frame: 6 hours

    The bolus dose given at skin incision was not included

  3. Recovery time in minutes

    Time frame: 10 minutes

    It is the time interval between discontinuation of isoflurane and extubation

  4. Intraoperative Heart rate as number of beats per minute

    Time frame: 6 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

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

Effect of Scalp Blocks on Postoperative Nausea & Vomiting & Recovery Profiles After Craniotomy: A Randomized, Double-Blind, and Controlled Study

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jan 27, 2020
Registry last updated
Aug 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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