the Effect of Erector Spinae Plane Block on Fentanyl Consumption During Abdominal Hysterectomy

Study Overview
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Brief Summary
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This study aims to evaluate the effects of erector spinae plane block on intraoperative fentanyl consumption in patients undergoing abdominal hysterectomy under general anesthesia. To our knowledge, no study in the literature demonstrates this effect.

Detailed Description
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This study will be performed in Fayoum University hospital after approval of the institutional ethics committee and written informed consent. This study will be conducted as a prospective, randomized, double-blind, parallel-group clinical trial. Inclusion criteria: American Society of Anesthesiologists (ASA) physical status I, II patients who will be scheduled for elective abdominal hysterectomy. Age range above 18. Exclusion criteria: Patient refusal. Significant renal, hepatic and cardiovascular diseases. History of allergy to one of the study drugs. Any contraindication to regional anesthesia such as local infection or bleeding disorders. Chronic opioid use, history of chronic pain and cognitive disorders. The patients will be randomized into two groups: ESP block group who will receive preoperative US-guided bilateral ESP block with 20 ml of bupivacaine 0.25% on each side and Control group who will undergo the same procedure but with an injection of 20 ml of saline on a 1:1 ratio using a computer-generated random table. The patient's assigned group information will be elicited from a sealed opaque envelope by the anesthesiologist who will perform the ESP block and will not be involved in further data collection or patient care. The patients and both the surgical and anesthesia teams, who are responsible for patient care and data collection are blinded from the group assignments.

Official Title
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the Effect of Erector Spinae Plane Block on Fentanyl Consumption During Abdominal Hysterectomy

Conditions
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Post Operative Pain

Intervention / Treatment
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* Procedure: ESP block


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - Inclusion criteria: American Society of Anesthesiologists (ASA) physical status I, II patients who will be scheduled for elective abdominal hysterectomy. Age range 18-70 years Exclusion Criteria: Patient refusal. Significant renal, hepatic, and cardiovascular diseases. History of allergy to one of the study drugs. Any contraindication to regional anesthesia such as local infection or bleeding disorders. Chronic opioid use, history of chronic pain and cognitive disorders.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

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
Interventional Model Description: This study will be conducted as a prospective, randomized, double-blind, parallel-group clinical trial.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ESP block<br>The patients will be randomized into two groups: ESP block group who will receive preoperative US-guided bilateral ESP block with 20 ml of bupivacaine 0.25% on each side | Procedure: ESP block<br>* ESP block group who will receive preoperative US-guided bilateral ESP block with 20 ml of bupivacaine 0.25% on each side<br>* Other names: regional anesthesia;|
| Sham Comparator: Control<br>The patients will be randomized into two groups: ESP block group who will receive preoperative US-guided bilateral ESP block with 20 ml of saline on each side | Procedure: ESP block<br>* ESP block group who will receive preoperative US-guided bilateral ESP block with 20 ml of bupivacaine 0.25% on each side<br>* Other names: regional anesthesia;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The total intraoperative fentanyl consumption (μg) | the total doses of intraoperative fentanyl consumption in (μg) | operative time in hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| intraoperative sevoflurane consumption (ml) | intraoperative sevoflurane consumption (ml) | operative time in hours | 
| post-operative fentanyl consumption in (μg) | post-operative fentanyl consumption in the first 24 hours (μg) | the first 24 hours postoperative | 
| VAS score | visual analog score | the first 24 hours postoperative | 
| mean operative times (min) | operative times duration in (min) | operative times in (min) |