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

Not Applicable

Recruiting

• Conditions: Postoperative Pain
• Interventions: Diagnostic Test: superficial cervical block; Diagnostic Test: without superficial cervical block

• Registration Number: NCT05816109
• Lead Sponsor: Aydin Adnan Menderes University

Brief Summary

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

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 Timeline

• Status Verified: 2023-01
• Study First Submitted: 2023-01-19
• Study First Submitted QC: 2023-04-03
• Last Update Submitted: 2023-04-03
• Study First Posted: 2023-04-18
• Last Update Posted: 2023-04-18
• Study Start: 2023-05-01
• Primary Completion: 2024-01-01
• Study Completion: 2024-02-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Superficial cervical block	superficial cervical block	Superficial Cervical Block
without superficial cervical block	without superficial cervical block	Without superficial cervical block

Primary Outcome Measures

Name	Time	Method
Qor-40 test (The recovery quality test)	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

Secondary Outcome Measures

Name	Time	Method
Postoperative pain	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.
NRS (Numerical rating scale)	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.

Trial Locations

Locations (1)

Adnan Menderes University Faculty of Medicine; 🇹🇷 Aydin, Turkey