Scalp Blocks Effect on Postoperative Nausea & Vomiting After Craniotomy

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

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

Study Overview

• Status: Completed
• Conditions: Postoperative Nausea and Vomiting
• Intervention / Treatment: Procedure: Scalp block; Other: Control Group

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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Raham Hasan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group S; Group S received scalp block with 20 ml of 0.5% bupivacaine	Procedure: Scalp block; 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.
Placebo Comparator: Group C; Group C will not have any intervention	Other: Control Group; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraoperative Mean blood pressure in mmHg	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	6 hours
Total intraoperative fentanyl consumption in microgram	The bolus dose given at skin incision was not included	6 hours
Recovery time in minutes	It is the time interval between discontinuation of isoflurane and extubation	10 minutes
Intraoperative Heart rate as number of beats per minute	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	6 hours

Collaborators and Investigators

• Sponsor: Ain Shams University
• Investigators: Principal Investigator: Raham Hasan Mostafa, MD, Assistant Lecturer of Anesthesia, Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): October 30, 2019
• Primary Completion (Actual): July 1, 2020
• Study Completion (Actual): July 1, 2020

Study Registration Dates

• First Submitted: January 16, 2020
• First Submitted That Met QC Criteria: January 23, 2020
• First Posted (Actual): January 27, 2020

Study Record Updates

• Last Update Posted (Actual): August 4, 2020
• Last Update Submitted That Met QC Criteria: August 3, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Signs and Symptoms, Digestive; Nausea; Vomiting; Postoperative Nausea and Vomiting
• Other Study ID Numbers: R 54/2019

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No