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

Primary Purpose

Post Operative Pain

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
ESP block
Sponsored by
Fayoum University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Post Operative Pain

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept 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.

Sites / Locations

  • Fayoum University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

ESP block

Control

Arm 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

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

Outcomes

Primary Outcome Measures

The total intraoperative fentanyl consumption (μg)
the total doses of intraoperative fentanyl consumption in (μg)

Secondary Outcome Measures

intraoperative sevoflurane consumption (ml)
intraoperative sevoflurane consumption (ml)
post-operative fentanyl consumption in (μg)
post-operative fentanyl consumption in the first 24 hours (μg)
VAS score
visual analog score
mean operative times (min)
operative times duration in (min)

Full Information

First Posted
September 28, 2021
Last Updated
July 25, 2022
Sponsor
Fayoum University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05072184
Brief Title
the Effect of Erector Spinae Plane Block on Fentanyl Consumption During Abdominal Hysterectomy
Official Title
the Effect of Erector Spinae Plane Block on Fentanyl Consumption During Abdominal Hysterectomy
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
October 1, 2021 (Actual)
Primary Completion Date
July 1, 2022 (Actual)
Study Completion Date
July 15, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fayoum University Hospital

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
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Operative Pain

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This study will be conducted as a prospective, randomized, double-blind, parallel-group clinical trial.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ESP block
Arm Type
Active Comparator
Arm 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
Arm Title
Control
Arm Type
Sham Comparator
Arm 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
Intervention Type
Procedure
Intervention Name(s)
ESP block
Other Intervention Name(s)
regional anesthesia
Intervention Description
ESP block group who will receive preoperative US-guided bilateral ESP block with 20 ml of bupivacaine 0.25% on each side
Primary Outcome Measure Information:
Title
The total intraoperative fentanyl consumption (μg)
Description
the total doses of intraoperative fentanyl consumption in (μg)
Time Frame
operative time in hours
Secondary Outcome Measure Information:
Title
intraoperative sevoflurane consumption (ml)
Description
intraoperative sevoflurane consumption (ml)
Time Frame
operative time in hours
Title
post-operative fentanyl consumption in (μg)
Description
post-operative fentanyl consumption in the first 24 hours (μg)
Time Frame
the first 24 hours postoperative
Title
VAS score
Description
visual analog score
Time Frame
the first 24 hours postoperative
Title
mean operative times (min)
Description
operative times duration in (min)
Time Frame
operative times in (min)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Fayoum University Hospital
City
Fayoum
ZIP/Postal Code
63511
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
no plane
Citations:
PubMed Identifier
32547172
Citation
Boules ML, Goda AS, Abdelhady MA, Abu El-Nour Abd El-Azeem SA, Hamed MA. Comparison of Analgesic Effect Between Erector Spinae Plane Block and Transversus Abdominis Plane Block After Elective Cesarean Section: A Prospective Randomized Single-Blind Controlled Study. J Pain Res. 2020 May 19;13:1073-1080. doi: 10.2147/JPR.S253343. eCollection 2020.
Results Reference
background
PubMed Identifier
23945838
Citation
Azari L, Santoso JT, Osborne SE. Optimal pain management in total abdominal hysterectomy. Obstet Gynecol Surv. 2013 Mar;68(3):215-27. doi: 10.1097/OGX.0b013e31827f5119.
Results Reference
result
PubMed Identifier
31118757
Citation
Hamed MA, Goda AS, Basiony MM, Fargaly OS, Abdelhady MA. Erector spinae plane block for postoperative analgesia in patients undergoing total abdominal hysterectomy: a randomized controlled study original study. J Pain Res. 2019 Apr 30;12:1393-1398. doi: 10.2147/JPR.S196501. eCollection 2019.
Results Reference
result

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

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