NCT05816109

Brief Summary

The Effect of Superficial Cervical Plexus Block on Postoperative Recovery Quality and Pain in Anterior Cervical Spinal Surgery

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at below P25 for not_applicable postoperative-pain

Timeline
Completed

Started May 2023

Geographic Reach
1 country

1 active site

Status
unknown

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

January 19, 2023

Completed
3 months until next milestone

First Posted

Study publicly available on registry

April 18, 2023

Completed
13 days until next milestone

Study Start

First participant enrolled

May 1, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2024

Completed
Last Updated

April 18, 2023

Status Verified

January 1, 2023

Enrollment Period

8 months

First QC Date

January 19, 2023

Last Update Submit

April 3, 2023

Conditions

Postoperative Pain

Keywords

Recovery QualityPostoperative PainSuperficial cervical blockCervical block

Outcome Measures

Primary Outcomes (1)

  • Qor-40 test (The recovery quality test)

    For this purpose, patients will be subjected to the Short Form-40- test , which is a short scale of postoperative recovery quality at first 24th hour. Minimum score is 40=bad, maximum score is 200=good

    24 th hour

Secondary Outcomes (2)

  • NRS (Numerical rating scale)

    30 minutes,1st hour,6th hour,12th hour and 24th hour]

  • Postoperative pain

    30 minutes, 1st hour, 6th hour, 12th hourand 24th hour

Study Arms (2)

Superficial cervical block

EXPERIMENTAL

Superficial Cervical Block

Diagnostic Test: superficial cervical block

without superficial cervical block

ACTIVE COMPARATOR

Without superficial cervical block

Diagnostic Test: without superficial cervical block

Interventions

superficial cervical blockDIAGNOSTIC_TEST

After anesthesia and surgical procedures, bilateral superficial cervical plexus block will be applied to the lower border of the sternocleidomastoid muscle, accompanied by ultrasonography. After cleaning the area with povidone iodine before the block, the sternocleidomastoid muscle and carotid artery and other vascular structures are determined using a linear ultrasound probe. Local anesthetic will be administered between the lower border of the sternocleidomastoid muscle and the upper border of the prevertebral fascia with the help of an insulated needle designed for peripheral block procedures. The location of the needle will be confirmed by hydrodissection method with saline before local anesthesia is given. After the location of the needle is confirmed, 2 ml of saline will be injected, followed by 10 ml of 0.5% bupivacaine. The deep cervical fascia of the superficial lamina will appear to open.

Superficial cervical block
without superficial cervical blockDIAGNOSTIC_TEST

patients who underwent anterior cervical surgery and did not undergo superficial cervical block

without superficial cervical block

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients undergoing lumbar spinal surgery under elective conditions
  • ASA I-III
  • Between 18-75 ages

You may not qualify if:

  • refuse during registration
  • request to be dismissed from study
  • failure to give informed consent
  • emergency surgery
  • bleeding diathesis
  • Presence of contraindications to the LA agents used in this study chronic use of opioids psychiatric disorders the presence of infection at the injection site

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Adnan Menderes University Faculty of Medicine

Aydin, 09010, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Central Study Contacts

Büşra CEYHAN CAN, Resident

CONTACT

+902564441256busraceyhancan@gmail.com

sinem Sarı ÖZTÜRK, associate

CONTACT

+902564441256sarisinem@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: Assignment
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate professor

Study Record Dates

First Submitted

January 19, 2023

First Posted

April 18, 2023

Study Start

May 1, 2023

Primary Completion

January 1, 2024

Study Completion

February 1, 2024

Last Updated

April 18, 2023

Record last verified: 2023-01

Locations

TU(1)