Scalp Blocks Effect on Postoperative Nausea & Vomiting After Craniotomy

Postoperative Nausea and Vomiting Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04240236
• Other study ID #: R 54/2019
• Status: Completed
• Phase: N/A
• Start date: October 30, 2019
• Est. completion date: July 1, 2020

Study information

• Verified date: August 2020
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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 information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: July 1, 2020
• Est. primary completion date: July 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Nausea
• Postoperative Nausea and Vomiting
• Vomiting

Intervention

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.

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.

Locations

Country	Name	City	State
Egypt	Raham Hasan	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Total intraoperative fentanyl consumption in microgram	The bolus dose given at skin incision was not included	6 hours
Secondary	Recovery time in minutes	It is the time interval between discontinuation of isoflurane and extubation	10 minutes
Secondary	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