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Scalp Blocks Effect on Postoperative Nausea & Vomiting After Craniotomy

Primary Purpose

Postoperative Nausea and Vomiting

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Scalp block
Control Group
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postoperative Nausea and Vomiting

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Raham Hasan

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Group S

Group C

Arm Description

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

Group C will not have any intervention

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
Total intraoperative fentanyl consumption in microgram
The bolus dose given at skin incision was not included
Recovery time in minutes
It is the time interval between discontinuation of isoflurane and extubation
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

Full Information

First Posted
January 16, 2020
Last Updated
August 3, 2020
Sponsor
Ain Shams University
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1. Study Identification

Unique Protocol Identification Number
NCT04240236
Brief Title
Scalp Blocks Effect on Postoperative Nausea & Vomiting After Craniotomy
Official Title
Effect of Scalp Blocks on Postoperative Nausea & Vomiting & Recovery Profiles After Craniotomy: A Randomized, Double-Blind, and Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
October 30, 2019 (Actual)
Primary Completion Date
July 1, 2020 (Actual)
Study Completion Date
July 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Nausea and Vomiting

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group S
Arm Type
Experimental
Arm Description
Group S received scalp block with 20 ml of 0.5% bupivacaine
Arm Title
Group C
Arm Type
Placebo Comparator
Arm Description
Group C will not have any intervention
Intervention Type
Procedure
Intervention Name(s)
Scalp block
Intervention 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.
Intervention Type
Other
Intervention Name(s)
Control Group
Intervention 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.
Primary Outcome Measure Information:
Title
PONV incidence & severity during the 1st 24 hours in ICU.
Description
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.
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Intraoperative Mean blood pressure in mmHg
Description
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
Time Frame
6 hours
Title
Total intraoperative fentanyl consumption in microgram
Description
The bolus dose given at skin incision was not included
Time Frame
6 hours
Title
Recovery time in minutes
Description
It is the time interval between discontinuation of isoflurane and extubation
Time Frame
10 minutes
Title
Intraoperative Heart rate as number of beats per minute
Description
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
Time Frame
6 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raham Hasan Mostafa, MD
Organizational Affiliation
Assistant Lecturer of Anesthesia, Ain Shams University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Raham Hasan
City
Cairo
Country
Egypt

12. IPD Sharing Statement

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Scalp Blocks Effect on Postoperative Nausea & Vomiting After Craniotomy

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