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

April 3, 2023 updated by: SINEM SARI, Aydin Adnan Menderes University
The Effect of Superficial Cervical Plexus Block on Postoperative Recovery Quality and Pain in Anterior Cervical Spinal Surgery

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The study was designed as a double-blind, prospective randomized controlled trial.

Blindness; The healthcare professionals who will monitor the patient's pain in the post-operative period will not know whether the superficial cervical plexus block is applied to the patients. Randomization of the patients was planned using computer aided. It is envisaged that 20 participants will be included in the patient group that will have a superficial cervical plexus block and will not have a superficial cervical plexus block. The current pain status in the postoperative period in the patient groups that will or will not have a superficial cervical plexus block is determined by NRS (Numerical rating scale) at rest and in motion at certain hour intervals ( 30.min,1.,6.,12.,24. hours) will be done, when the patients' NRS scores are 4 and above, an additional intravenous analgesic will be administered, and the number of bolus doses with PCA in the first 24 hours will be recorded. The quality of recovery (QoR-40) scoring system will be evaluated at the postoperative 24th hour of both patients with and without superficial cervical plexus block. In addition, the hemodynamic values of the patients will be recorded in these intervals.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Turkey
      • Aydin, Turkey, 09010
        • Recruiting
        • Adnan Menderes University Faculty of Medicine
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Superficial cervical block
Superficial Cervical Block
Diagnostic test: superficial cervical block
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.
Active Comparator: without superficial cervical block
Without superficial cervical block
Diagnostic test: without superficial cervical block
patients who underwent anterior cervical surgery and did not undergo superficial cervical block

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Qor-40 test (The recovery quality test)
Time Frame: 24 th hour
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
NRS (Numerical rating scale)
Time Frame: 30 minutes,1st hour,6th hour,12th hour and 24th hour]
It is pain intensity determination system based on the system where the person tells a point between 0=(no pain), 10= (unbearable pain) and to describe their pain.
30 minutes,1st hour,6th hour,12th hour and 24th hour]
Postoperative pain
Time Frame: 30 minutes, 1st hour, 6th hour, 12th hourand 24th hour
Postoperative opioid consumotions on the pca (patient controlled analgesia) device of the patients will be recorded in Postoperative 30. min, 1., 6., 12., 24. Opioid consumptions on the pca device of the patients will be recorded in 30. min, 1., 6., 12., 24. hours.
30 minutes, 1st hour, 6th hour, 12th hourand 24th hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aydin Adnan Menderes University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

May 1, 2023

Primary Completion (Anticipated)

January 1, 2024

Study Completion (Anticipated)

February 1, 2024

Study Registration Dates

First Submitted

January 19, 2023

First Submitted That Met QC Criteria

April 3, 2023

First Posted (Actual)

April 18, 2023

Study Record Updates

Last Update Posted (Actual)

April 18, 2023

Last Update Submitted That Met QC Criteria

April 3, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022/09

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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