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Completed

NCT Number: NCT05072184

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

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.

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Key information

Age range

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Fayoum University Hospital

Al Fayyum, 63511, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ESP block

Procedure

ESP block group who will receive preoperative US-guided bilateral ESP block with 20 ml of bupivacaine 0.25% on each side

Other names: regional anesthesia

Primary outcomes

  1. The total intraoperative fentanyl consumption (μg)

    Time frame: operative time in hours

    the total doses of intraoperative fentanyl consumption in (μg)

Secondary outcomes

  1. intraoperative sevoflurane consumption (ml)

    Time frame: operative time in hours

    intraoperative sevoflurane consumption (ml)

  2. post-operative fentanyl consumption in (μg)

    Time frame: the first 24 hours postoperative

    post-operative fentanyl consumption in the first 24 hours (μg)

  3. VAS score

    Time frame: the first 24 hours postoperative

    visual analog score

  4. mean operative times (min)

    Time frame: operative times in (min)

    operative times duration in (min)

Sponsors and collaborators

Lead sponsor

Fayoum University Hospital

Other

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Oct 8, 2021
Registry last updated
Jul 26, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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