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

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05816109
• Other study ID #: 2022/09
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2023
• Est. completion date: February 1, 2024

Study information

• Verified date: January 2023
• Source: Aydin Adnan Menderes University
• Contact: Büsra CEYHAN CAN, Resident
• Phone: +902564441256
• Email: busraceyhancan[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: February 1, 2024
• Est. primary completion date: January 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

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.
• without superficial cervical block
patients who underwent anterior cervical surgery and did not undergo superficial cervical block

Locations

Country	Name	City	State
Turkey	Adnan Menderes University Faculty of Medicine	Aydin

Sponsors (1)

Lead Sponsor	Collaborator
Aydin Adnan Menderes University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	NRS (Numerical rating scale)	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]
Secondary	Postoperative pain	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