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

NCT ID: NCT05816109

Last Updated: 2023-04-18

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-01

Study Completion Date

2024-02-01

Brief Summary

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

Detailed Description

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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.

Conditions

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Postoperative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Assignment
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Superficial cervical block

Superficial Cervical Block

Group Type EXPERIMENTAL

superficial cervical block

Intervention Type DIAGNOSTIC_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.

without superficial cervical block

Without superficial cervical block

Group Type ACTIVE_COMPARATOR

without superficial cervical block

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

without superficial cervical block

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aydin Adnan Menderes University

OTHER

Sponsor Role lead

Responsible Party

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SINEM SARI

associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Adnan Menderes University Faculty of Medicine

Aydin, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Büşra CEYHAN CAN, Resident

Role: CONTACT

+902564441256

sinem Sarı ÖZTÜRK, associate

Role: CONTACT

+902564441256

Facility Contacts

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büşra ceyhan can, resident doctor

Role: primary

+902564441256

sinem sari, associate proffesor

Role: backup

+902564441256

Other Identifiers

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2022/09

Identifier Type: -

Identifier Source: org_study_id

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