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

Scalp Blocks Effect on Postoperative Nausea & Vomiting After Craniotomy

Sponsors

Lead sponsor: Ain Shams University

Source Ain Shams University
Brief Summary

In this study, we 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

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.

Overall Status Recruiting
Start Date October 30, 2019
Completion Date December 2020
Primary Completion Date July 2020
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
PONV incidence & severity during the 1st 24 hours in ICU. 24 hours
Secondary Outcome
Measure Time Frame
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
Enrollment 40
Condition
Intervention

Intervention type: Procedure

Intervention name: Scalp block

Description: 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.

Arm group label: Group S

Intervention type: Other

Intervention name: Control Group

Description: 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.

Arm group label: Group C

Eligibility

Criteria:

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

Gender: All

Minimum age: 18 Years

Maximum age: 50 Years

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Raham Hasan Mostafa, MD Principal Investigator Assistant Lecturer of Anesthesia, Ain Shams University
Overall Contact

Last name: Assistant Lecturer of Anesthesia

Phone: +201222530020

Email: [email protected]

Location
facility status contact
Raham Hasan Recruiting Raham Hasan +201222530020 [email protected]
Location Countries

Egypt

Verification Date

January 2020

Responsible Party

Responsible party type: Principal Investigator

Investigator affiliation: Ain Shams University

Investigator full name: Raham Hasan Mostafa, MD

Investigator title: Assistant Professor of Anesthesia

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: Group S

Arm group type: Experimental

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

Arm group label: Group C

Arm group type: Placebo Comparator

Description: Group C will not have any intervention

Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Prevention

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Source: ClinicalTrials.gov