Scalp Blocks Effect on Postoperative Nausea & Vomiting After Craniotomy

NCT04240236 | Completed DMC

• 1 other identifier: R 54/2019
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Conditions

Postoperative Nausea and Vomiting

Outcome Measures

Primary Outcomes (1)

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

  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.

  24 hours

Secondary Outcomes (4)

• Intraoperative Mean blood pressure in mmHg

  6 hours

• Total intraoperative fentanyl consumption in microgram

  6 hours

• Recovery time in minutes

  10 minutes

• Intraoperative Heart rate as number of beats per minute

  6 hours

Study Arms (2)

Group S

EXPERIMENTAL

Group S received scalp block with 20 ml of 0.5% bupivacaine

Procedure: Scalp block

Group C

PLACEBO COMPARATOR

Group C will not have any intervention

Other: Control Group

Interventions

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.

Group S

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.

Group C

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Raham Hasan

Cairo, Egypt

Location

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Interventions

Control Groups

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Raham Hasan Mostafa, MD

  Assistant Lecturer of Anesthesia, Ain Shams University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Anesthesia

Study Record Dates

• First Submitted: January 16, 2020
• First Posted: January 27, 2020
• Study Start: October 30, 2019
• Primary Completion: July 1, 2020
• Study Completion: July 1, 2020
• Last Updated: August 4, 2020

Record last verified: 2020-08

Locations

EG (1)