NCT06419556

Brief Summary

This study aims to investigate the analgesic efficacy of Intermediate Cervical Plexus Block combined with GA using two bupivacaine concentrations in patients undergoing neck surgeries (total thyroidectomy or total laryngectomy)

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2023

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Start

First participant enrolled

March 5, 2023

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

May 14, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 17, 2024

Completed
15 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
Last Updated

May 17, 2024

Status Verified

May 1, 2024

Enrollment Period

1.2 years

First QC Date

May 14, 2024

Last Update Submit

May 14, 2024

Conditions

AnesthesiaThyroidNeckBupivacaine

Keywords

Neck surgeriesCervical Plexus BlockBupivacaine

Outcome Measures

Primary Outcomes (1)

  • Duration of analgesia

    duration of anesthesia and Block-skin incision time differ between two groups (two concentrations of bupivacaine)

    duration of operation up to 6 hours

Secondary Outcomes (5)

  • The diaphragmatic motions measured by M-mode ultrasonography

    duration of operation up to 6 hours

  • Total postoperative Morphine consumption.

    24 hours

  • The postoperative VAS score

    24 hours

  • Hemodynamics

    duration of operation up to 6 hours

  • opioid consumption.

    duration of operation up to 6 hours

Study Arms (2)

Group H

EXPERIMENTAL

The patient's head was rested on a pillow and turned to the opposite side. A linear probe with higher frequencies was placed transversely over the midpoint of the SCM muscle. The carotid artery was identified and traced upwards to its bifurcation. Probe was then moved laterally to identify the tapering posterolateral end of the SCM muscle. Via an in-plane technique, a 22-gauge, 50 mm needle was advanced underneath the investing fascia of SCM muscle and above the interscalene groove until the "pop" on piercing the investing fascia was felt. Group H received 20 ml 0.25 % bupivacaine

Procedure: Cervical Plexus Block

Group L received 20 ml 0.125% bupivacaine

ACTIVE COMPARATOR

The patient's head was rested on a pillow and turned to the opposite side. A linear probe with higher frequencies was placed transversely over the midpoint of the SCM muscle. The carotid artery was identified and traced upwards to its bifurcation. Probe was then moved laterally to identify the tapering posterolateral end of the SCM muscle. Via an in-plane technique, a 22-gauge, 50 mm needle was advanced underneath the investing fascia of SCM muscle and above the interscalene groove until the "pop" on piercing the investing fascia was felt. Group L received 20 ml 0.125% bupivacaine.

Procedure: Cervical Plexus Block

Interventions

Cervical Plexus BlockPROCEDURE

The patient's head was rested on a pillow and turned to the opposite side. A linear probe with higher frequencies was placed transversely over the midpoint of the SCM muscle. The carotid artery was identified and traced upwards to its bifurcation. the probe was then moved laterally to identify the tapering posterolateral end of the SCM muscle. Via an in-plane technique, a 22-gauge, 50 mm needle was advanced underneath the investing fascia of SCM muscle and above the interscalene groove until the "pop" on piercing the investing fascia was felt.

Group HGroup L received 20 ml 0.125% bupivacaine

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Any patient aged ≥ 40 years
  • ASA physical status I-III scheduled for total thyroidectomy or total laryngectomy under GA.

You may not qualify if:

  • Patients with heart failure
  • history of arrhythmias
  • treatment with antiarrhythmic drugs
  • impaired pulmonary
  • Liver or kidney functions
  • Neck infection or rash

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo university Hospitals. kasralainy

Cairo, Governorate, 002, Egypt

RECRUITING

MeSH Terms

Conditions

Thyroid Diseases

Interventions

Cervical Plexus Block

Condition Hierarchy (Ancestors)

Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Nerve BlockAnesthesia, ConductionAnesthesiaAnesthesia and Analgesia

Central Study Contacts

Nagy malak

CONTACT

01552480258nagymalak@kasralainy.edu.eg

Nagy malak

CONTACT

01552480258nagymalak12345@gmail.com

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
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of anesthesia ,SICU and pain

Study Record Dates

First Submitted

May 14, 2024

First Posted

May 17, 2024

Study Start

March 5, 2023

Primary Completion

June 1, 2024

Study Completion

June 1, 2024

Last Updated

May 17, 2024

Record last verified: 2024-05

Locations

EG(1)