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

NCT ID: NCT05892887

Last Updated: 2023-10-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-01

Study Completion Date

2023-09-20

Brief Summary

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

Detailed Description

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The erector spinae plane block (ESPB) its an interfacial plane block for an effective treatment for thoracic neuropathic pain. Currently, compared to the use of opioids, the ESPB has fewer side effects and is safe for patients of all ages having abdominal and thoracic operations .

Conditions

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Analgesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Erector 10

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

Group Type EXPERIMENTAL

Bupivacaine 0.25% Injectable Solution

Intervention Type DRUG

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

Erector 15

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

Group Type EXPERIMENTAL

Bupivacaine 0.25% Injectable Solution

Intervention Type DRUG

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

Erector 20

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

Group Type EXPERIMENTAL

Bupivacaine 0.25% Injectable Solution

Intervention Type DRUG

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

Interventions

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Bupivacaine 0.25% Injectable Solution

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kafrelsheikh University

OTHER

Sponsor Role lead

Responsible Party

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Mohamed Fouad Algyar

Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Kafrelsheikh University, Kafrelsheikh, Egypt

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Kafrelsheikh University

Kafr ash Shaykh, Kafrelsheikh, Egypt

Site Status

Countries

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Egypt

References

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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.

Reference Type DERIVED
PMID: 40890575 (View on PubMed)

Other Identifiers

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MKSU 50- 1 - 10

Identifier Type: -

Identifier Source: org_study_id

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