The Effect of Superficial Cervical Plexus Block on Postoperative Recovery Quality and Pain in Anterior Cervical Spinal Surgery
Primary Purpose
Postoperative Pain
Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
superficial cervical block
without superficial cervical block
Sponsored by
About this trial
This is an interventional treatment trial for Postoperative Pain focused on measuring Recovery Quality, Postoperative Pain, Superficial cervical block, Cervical block
Eligibility Criteria
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
Sites / Locations
- Adnan Menderes University Faculty of MedicineRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Superficial cervical block
without superficial cervical block
Arm Description
Superficial Cervical Block
Without superficial cervical block
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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.
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.
Full Information
NCT ID
NCT05816109
First Posted
January 19, 2023
Last Updated
April 3, 2023
Sponsor
Aydin Adnan Menderes University
1. Study Identification
Unique Protocol Identification Number
NCT05816109
Brief Title
The Effect of Superficial Cervical Plexus Block on Postoperative Recovery Quality and Pain in Anterior Cervical Spinal Surgery
Official Title
The Effect of Superficial Cervical Plexus Block on Postoperative Recovery Quality and Pain in Anterior Cervical Spinal Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2023 (Anticipated)
Primary Completion Date
January 1, 2024 (Anticipated)
Study Completion Date
February 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aydin Adnan Menderes University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
Keywords
Recovery Quality, Postoperative Pain, Superficial cervical block, Cervical block
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Superficial cervical block
Arm Type
Experimental
Arm Description
Superficial Cervical Block
Arm Title
without superficial cervical block
Arm Type
Active Comparator
Arm Description
Without superficial cervical block
Intervention Type
Diagnostic Test
Intervention Name(s)
superficial cervical block
Intervention Description
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
Intervention Name(s)
without superficial cervical block
Intervention Description
patients who underwent anterior cervical surgery and did not undergo superficial cervical block
Primary Outcome Measure Information:
Title
Qor-40 test (The recovery quality test)
Description
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
Time Frame
24 th hour
Secondary Outcome Measure Information:
Title
NRS (Numerical rating scale)
Description
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.
Time Frame
30 minutes,1st hour,6th hour,12th hour and 24th hour]
Title
Postoperative pain
Description
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.
Time Frame
30 minutes, 1st hour, 6th hour, 12th hourand 24th hour
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Büşra CEYHAN CAN, Resident
Phone
+902564441256
Email
busraceyhancan@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
sinem Sarı ÖZTÜRK, associate
Phone
+902564441256
Email
sarisinem@yahoo.com
Facility Information:
Facility Name
Adnan Menderes University Faculty of Medicine
City
Aydin
ZIP/Postal Code
09010
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
büşra ceyhan can, resident doctor
Phone
+902564441256
Email
busraceyhancan@gmail.com
First Name & Middle Initial & Last Name & Degree
sinem sari, associate proffesor
Phone
+902564441256
Email
sarisinem@yahoo.com
12. IPD Sharing Statement
Learn more about this trial
The Effect of Superficial Cervical Plexus Block on Postoperative Recovery Quality and Pain in Anterior Cervical Spinal Surgery
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