NCT05577559

Brief Summary

• 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
58

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 9, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 13, 2022

Completed
19 days until next milestone

Study Start

First participant enrolled

November 1, 2022

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

December 29, 2023

Status Verified

December 1, 2023

Enrollment Period

1.1 years

First QC Date

October 9, 2022

Last Update Submit

December 22, 2023

Conditions

Analgesia

Outcome Measures

Primary Outcomes (1)

  • The time to first call to rescue analgesia

    The time to first call to rescue analgesia (nalbuphine) the time between the end of surgery to first report of postoperative pain. will be recorded.

    24 hour postoperative

Secondary Outcomes (3)

  • The total amount of nalbuphine

    24 hour postoperative

  • Pain intensity

    up to 24hs postoperative

  • Total intra-operative fentanyl consumption

    intra-operative

Study Arms (2)

Superficial cervical group

ACTIVE COMPARATOR

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

Procedure: intermediate cervical plexus block

Erector spinae group

ACTIVE COMPARATOR

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.

Procedure: Cervical Erector spinae block

Interventions

intermediate cervical plexus blockPROCEDURE

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

Superficial cervical group
Cervical Erector spinae blockPROCEDURE

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.

Erector spinae group

Eligibility Criteria

Age21 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Human Medicine, Zagazig University

Zagazig, Egypt

Location

Related Publications (1)

  • 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.

    PMID: 38649826DERIVED

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Alshaimaa Kamel, MD.

    Zagazig University, Faculty of Human Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor of Anesthesia, Intensive Care and Pain Management

Study Record Dates

First Submitted

October 9, 2022

First Posted

October 13, 2022

Study Start

November 1, 2022

Primary Completion

December 1, 2023

Study Completion

December 1, 2023

Last Updated

December 29, 2023

Record last verified: 2023-12

Locations

EG(1)