Scalp Blocks Effect on Postoperative Nausea & Vomiting After Craniotomy

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Postoperative Nausea and Vomiting

Intervention / Treatment
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* Procedure: Scalp block
* Other: Control Group


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

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

What is the study measuring?
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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 |