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

NCT05072184 | Completed DMC

• 1 other identifier: M546
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Post Operative Pain

Outcome Measures

Primary Outcomes (1)

• The total intraoperative fentanyl consumption (μg)

  the total doses of intraoperative fentanyl consumption in (μg)

  operative time in hours

Secondary Outcomes (4)

• intraoperative sevoflurane consumption (ml)

  operative time in hours

• post-operative fentanyl consumption in (μg)

  the first 24 hours postoperative

• VAS score

  the first 24 hours postoperative

• mean operative times (min)

  operative times in (min)

Study Arms (2)

ESP block

ACTIVE COMPARATOR

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

Control

SHAM COMPARATOR

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

Interventions

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

Also known as: regional anesthesia

Control; ESP block

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• American Society of Anesthesiologists (ASA) physical status I, II patients who will be scheduled for elective abdominal hysterectomy.
• Age range 18-70 years

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fayoum University Hospital: lead

Study Sites (1)

Fayoum University Hospital

Al Fayyum, 63511, Egypt

Location

Related Publications (4)

• 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.

  PMID: 32547172 BACKGROUND

• 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.

  PMID: 23945838 RESULT

• 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.

  PMID: 31118757 RESULT

• 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.

  PMID: 37277703 DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Anesthesia, Conduction

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anesthesia; Anesthesia and Analgesia

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

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

Study Record Dates

• First Submitted: September 28, 2021
• First Posted: October 8, 2021
• Study Start: October 1, 2021
• Primary Completion: July 1, 2022
• Study Completion: July 15, 2022
• Last Updated: July 26, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)