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Ultrasound-Guided Intermediate Cervical Plexus or Cervical Erector Spinae Block for Anterior Cervical Spine Surgery

NCT ID: NCT05577559

Last Updated: 2023-12-29

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

NA

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-01

Study Completion Date

2023-12-01

Brief Summary

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• Neck pain and stiffness or sore throat, are common after anterior cervical spine surgery. Complications are rare but can be serious and even potentially life-threatening if they do occur. Rapid recovery and emergence from general anesthesia are important in cases of anterior cervical spine surgery.

Detailed Description

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* Null hypothesis (H0): No difference between the regional analgesia effects of bilateral ultrasound-guided superficial cervical plexus block and bilateral cervical erector spinae block in patients undergoing anterior cervical spine surgery under general anesthesia.
* Alternative hypothesis (H1): There are differences between the regional analgesia effects of bilateral ultrasound-guided superficial cervical plexus block and bilateral cervical erector spinae block in

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 Outcome Assessors

Study Groups

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Superficial cervical group

patients will receive bilateral ultrasound guided intermediate cervical plexus block using 15 ml of bupivacaine 0.25% for each side.

Group Type ACTIVE_COMPARATOR

intermediate cervical plexus block

Intervention Type PROCEDURE

patients will receive bilateral ultrasound guided intermediate cervical plexus block using 15 ml of bupivacaine 0.25% for each side.

Erector spinae group

patients will receive bilateral ultrasound guided cervical erector spinae plane block using 15 ml of bupivacaine 0.25% for each side at the level of C6.

Group Type ACTIVE_COMPARATOR

Cervical Erector spinae block

Intervention Type PROCEDURE

patients will receive bilateral ultrasound guided cervical erector spinae plane block using 15 ml of bupivacaine 0.25% for each side at the level of C6.

Interventions

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intermediate cervical plexus block

patients will receive bilateral ultrasound guided intermediate cervical plexus block using 15 ml of bupivacaine 0.25% for each side.

Intervention Type PROCEDURE

Cervical Erector spinae block

patients will receive bilateral ultrasound guided cervical erector spinae plane block using 15 ml of bupivacaine 0.25% for each side at the level of C6.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patient acceptance.
* Age (21-60) years old.
* Both sex
* American Society of Anesthesiologist physical status I / II
* Elective anterior cervical spine surgery under general anesthesia.
* patient With Body Mass Index (BMI) (25-35kg/m²)

Exclusion Criteria

* Local infection at site of puncture.
* Altered mental status.
* History of allergy to study drugs ( bupivacaine, fentanyl).
* Patients with chronic pain.
* Patients with severe hepatic or kidney impairment.
* Patients having a history of hematological disorders, including coagulation abnormality.
Minimum Eligible Age

21 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Zagazig University

OTHER_GOV

Sponsor Role lead

Responsible Party

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Alshaimaa Abdel Fattah Kamel

Assistant professor of Anesthesia, Intensive Care and Pain Management

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Alshaimaa Kamel, MD.

Role: PRINCIPAL_INVESTIGATOR

Zagazig University, Faculty of Human Medicine

Locations

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Faculty of Human Medicine, Zagazig University

Zagazig, , Egypt

Site Status

Countries

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Egypt

References

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Kamel AAF, Fahmy AM, Fathi HM, Elmesallamy WAEA, Khalifa OYA. Regional analgesia using ultrasound-guided intermediate cervical plexus block versus cervical erector spinae block for anterior cervical spine surgery: a randomized trial. BMC Anesthesiol. 2024 Apr 22;24(1):153. doi: 10.1186/s12871-024-02533-6.

Reference Type DERIVED
PMID: 38649826 (View on PubMed)

Other Identifiers

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9790

Identifier Type: -

Identifier Source: org_study_id