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

Fayoum University Hospital

Status: Completed

Conditions: Post Operative Pain

Treatments: Procedure: ESP block

Study type: Interventional

Funder types: Other

Identifiers

NCT05072184

M546

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 100 patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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100 participants in 2 patient groups

ESP block

Active Comparator group

Description:

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

Treatment:

Procedure: ESP block

Control

Sham Comparator group

Description:

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

Treatment:

Procedure: ESP block