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

NCT ID: NCT05072184

Last Updated: 2022-07-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-01
• Study Completion Date: 2022-07-15

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.

Conditions

Post Operative Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

ESP block

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

Group Type: ACTIVE_COMPARATOR

ESP block

Intervention Type: PROCEDURE

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

Control

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

Group Type: SHAM_COMPARATOR

ESP block

Intervention Type: PROCEDURE

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

Interventions

ESP block

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

Intervention Type: PROCEDURE

Other Intervention Names

regional anesthesia

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Fayoum University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Mohamed Ahmed Hamed

Associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Fayoum University Hospital

Al Fayyum, , Egypt

Countries

Egypt

References

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.

Reference Type: BACKGROUND

PMID: 32547172 (View on PubMed)

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.

Reference Type: RESULT

PMID: 23945838 (View on PubMed)

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.

Reference Type: RESULT

PMID: 31118757 (View on PubMed)

Hamed MA, Boules ML, Mahmoud MAEM, Abdelghaffar RA. The effect of erector spinae plane block on fentanyl consumption during open abdominal hysterectomy: a randomised controlled study. BMC Anesthesiol. 2023 Jun 5;23(1):194. doi: 10.1186/s12871-023-02156-3.

Reference Type: DERIVED

PMID: 37277703 (View on PubMed)

Other Identifiers

M546

Identifier Type: -

Identifier Source: org_study_id