Analgesic Efficacy of Different Volumes in Erector Spinae Plane Block in Single Level Lumbar Spine Fixation

NCT05892887 | Completed Phase 4

• 1 other identifier: MKSU 50- 1 - 10
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The analgesic efficacy of different volumes in ESPB patients undergoing single-level lumbar spine fixation

Conditions

Analgesia

Outcome Measures

Primary Outcomes (1)

• Total morphine consumption

  Patients were allowed to receive incremental doses of morphine 3mg intravenously if numerical rating scale pain score will be ≥ then the total amount of morphine will be recorded

  First 24 hours postoperatively

Secondary Outcomes (4)

• Numerical rating scale

  Up to 48 hours postoperatively

• Time to the first rescue analgesic

  Up to 24 hours postoperatively

• Postoperative complications

  Up to 24 hours postoperatively

• 5-point scale

  Up to 24 hours postoperative

Study Arms (3)

Erector 10

EXPERIMENTAL

Received 10ml of preoperative bilateral ultrasound guided ESPB by bupivacaine 0.25% on each side

Drug: Bupivacaine 0.25% Injectable Solution

Erector 15

EXPERIMENTAL

Received 15ml of preoperative bilateral ultrasound guided ESPB by bupivacaine 0.25% on each side

Drug: Bupivacaine 0.25% Injectable Solution

Erector 20

EXPERIMENTAL

Received 20ml of preoperative bilateral ultrasound guided ESPB by bupivacaine 0.25% on each side

Drug: Bupivacaine 0.25% Injectable Solution

Interventions

Bupivacaine 0.25% Injectable Solution DRUG

Bilateral ultrasound guided in erector spinae plane block by bupivacaine 0.25%

Erector 10; Erector 15; Erector 20

Eligibility Criteria

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

You may qualify if:

• Aged 18-65 years.
• Both genders.
• American Society of Anesthesiologists' (ASA) physical status I or II.
• Undergoing single level lumbar spine fixation.

You may not qualify if:

• Patient refusal.
• Pregnant females.
• Renal, lung, heart, or liver disorders.
• Communication difficulties which might prevent a reliable postoperative assessment.
• Contraindication to regional anesthesia (bleeding disorder, use of any anticoagulants, local infection, known allergy to local anesthetics).
• BMI more than 30 kg/m2.

Sponsors & Collaborators

• Kafrelsheikh University: lead

Study Sites (1)

Kafrelsheikh University

Kafr ash Shaykh, Kafrelsheikh, 33516, Egypt

Location

Related Publications (1)

• Algyar MF, Zahra AA, Elshikhali AS, Abdelhameed EA, El Hefny DA, Moharam SA, ElSharkawy MS, Farghaly OS, Ahmed MA. Analgesic efficacy of different volumes in erector spinae plane block in patients undergoing single level lumbar spine fixation: a non-inferiority randomized trial. BMC Anesthesiol. 2025 Sep 1;25(1):439. doi: 10.1186/s12871-025-03247-z.

  PMID: 40890575 DERIVED

MeSH Terms

Conditions

Agnosia

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Kafrelsheikh University, Kafrelsheikh, Egypt

Study Record Dates

• First Submitted: May 10, 2023
• First Posted: June 7, 2023
• Study Start: June 1, 2023
• Primary Completion: September 20, 2023
• Study Completion: September 20, 2023
• Last Updated: October 10, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: The data will be available after the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)