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Regional Analgesia for Anterior Cervical Disc and Fusion Surgery

Primary Purpose

Postoperative Pain, Shoulder Pain, Anesthesia, Local

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
superficial cervical plexus block
cervical erector spinae plane block
Sponsored by
Basaksehir Cam & Sakura Şehir Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain focused on measuring cervical erector spinae block, anterior cervical disc and fusion surgery, postoperative analgesic consumption, superficial cervical plexus block

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: ASA (American Society of Anesthesiologists) Classification I-II Anterior Cervical Disc and Fusion Surgery Exclusion Criteria: Patients with bleeding diathesis Neurological disease, BMI (Body Mass Index) less than 19 or greater than 30 The presence of infection in the neck area Patients who do not accept the procedure

Sites / Locations

  • Ergun MendesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Group sCPB

Group cESP

Arm Description

Superficial cervical plexus block, patients who applied sCPB for postoperative pain

Cervical erector spinae plane block, patients who applied cervical ESP block for postoperative pain

Outcomes

Primary Outcome Measures

Qualitif of Recovery-15 (QoR-15)
The QoR-15 scale is a unidimensional measurement of quality of recovery measured in five domains: physical comfort, pain, physical independence, psychological support, and emotional state. The QoR-15 scale provides a score ranging from 0 to 150, with a high score indicating a good quality of recovery
VAS (Visual Analog Scala) score
The patients were followed up with a VAS score between 0-10 in the postoperative period. A VAS score of 0 was defined as no pain, and 10 as the most severe pain imaginable.

Secondary Outcome Measures

Analgesic consumption
The value in mg of the amount of analgesic consumed in the postoperative period. It was administered with a PCA device that had regular infusions and was able to deliver bolus doses at regular intervals.
Postoperative nausea and vomiting
The frequency of nausea and vomiting in the postoperative period was calculated according to the Numeric Rank Score (NRS), which ranged from 0 to 3. Nausea-vomiting status of the patients: 0 points if there is no nausea and vomiting; 1 point if there is nausea, no vomiting; It is scored as 2 points if there is vomiting once and 3 points if there are two or more vomiting attacks.
Chronic Pain
Evaluation of shoulder pain level in terms of chronic pain in the postoperative period. It was evaluated using the VAS (Visual Analog Scala) score. The patients were followed up with a VAS score between 0-10 in the postoperative period. A VAS score of 0 was defined as no pain, and 10 as the most severe pain imaginable.

Full Information

First Posted
November 22, 2022
Last Updated
July 6, 2023
Sponsor
Basaksehir Cam & Sakura Şehir Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05680142
Brief Title
Regional Analgesia for Anterior Cervical Disc and Fusion Surgery
Official Title
Efficacy of Cervical Erector Spina Plane Block and Superficial Cervical Plexus Block in Anterior Cervical Disc and Fusion Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 6, 2023 (Actual)
Primary Completion Date
January 22, 2024 (Anticipated)
Study Completion Date
February 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Basaksehir Cam & Sakura Şehir Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Erector Spina Plane (ESP) block has been widely used in recent years, and it is also used in the control of postoperative analgesia in many types of surgery due to its proximity to the central area and its wide spread feature. In this study, the investigators aimed to demonstrate the effectiveness of ESP block on postoperative pain management in anterior cervical disc and fusion surgeries.
Detailed Description
This study includes ASA I-II patients aged 18-65 years who will undergo Anterior Cervical Disc and Fusion Surgery at C5 or C6 level under general anesthesia under elective conditions. In the preoperative period, the participant groups will be divided into two separate groups, Group cESP and Group sCPB, according to the type of block applied. Groups will be compared according to demographic data, duration of surgery, perioperative drug consumption, postoperative pain scores, additional analgesic requirement and presence of shoulder pain. The blocks will be applied with the help of an 8-12 mHz linear probe after the patients are determined by the closed envelope method. In group cESP, block will be applied using in-plane technique at the level of C6 or C7 transverse vertebral corpus in the fascia between the semispinalis capitis muscle and the posterior scalene muscle. During the block, a total of 20 mL volume of 0.25% bupivacaine concentration will be given bilaterally to all patients. Group sCPB will be administered using 10 mL of 0.25% bupivacaine by entering from the C4 level from the right side of the neck from the posterior side of the sternocleidomastoid muscle. It was planned to routinely administer 10 mg/kg paracetamol and 2x10 mg tenoxicam iv to all patients for postoperative pain control. Patients will be taken to the recovery unit in the postoperative period, where their analgesic needs, frequency of nausea-vomiting, VAS scores, and additional problems will be followed up by the nurse who was included in the study blindly. After 1 hour of follow-up in the Recovery Unit, the participants will be directed to the service. The participants' VAS scores and additional analgesic needs will be recorded at 6, 12, and 24 hours postoperatively.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain, Shoulder Pain, Anesthesia, Local, Disc Herniation
Keywords
cervical erector spinae block, anterior cervical disc and fusion surgery, postoperative analgesic consumption, superficial cervical plexus block

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
In the preoperative period, the participant groups will be divided into two separate groups, Group cESP and Group sCPB, according to the type of block applied.
Masking
Care ProviderOutcomes Assessor
Masking Description
After the block, another anesthetist who did not know which group the patient belonged to was included in the study blindly. The patients were taken to the recovery unit in the postoperative period, and their analgesic needs, frequency of nausea and vomiting, VAS scores and additional problems were followed up by the nurse who was blindly included in the study.
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group sCPB
Arm Type
Active Comparator
Arm Description
Superficial cervical plexus block, patients who applied sCPB for postoperative pain
Arm Title
Group cESP
Arm Type
Active Comparator
Arm Description
Cervical erector spinae plane block, patients who applied cervical ESP block for postoperative pain
Intervention Type
Drug
Intervention Name(s)
superficial cervical plexus block
Other Intervention Name(s)
sCPB
Intervention Description
The superficial cervical plexus block is applied as part of our routine protocol for postoperative pain control. Group sCPB will be administered from the C4 level by entering the posterior border of the sternocleidomastoid muscle from the right side of the neck.
Intervention Type
Drug
Intervention Name(s)
cervical erector spinae plane block
Other Intervention Name(s)
cESP
Intervention Description
The cervical erector spinae plane block is applied as part of our routine protocol for postoperative pain control. Group cESP is applied to the fascia between the semispinalis capitis muscle and the posterior scalene muscle of the C6 or C7 transverse process.
Primary Outcome Measure Information:
Title
Qualitif of Recovery-15 (QoR-15)
Description
The QoR-15 scale is a unidimensional measurement of quality of recovery measured in five domains: physical comfort, pain, physical independence, psychological support, and emotional state. The QoR-15 scale provides a score ranging from 0 to 150, with a high score indicating a good quality of recovery
Time Frame
Postoperative 24th hour
Title
VAS (Visual Analog Scala) score
Description
The patients were followed up with a VAS score between 0-10 in the postoperative period. A VAS score of 0 was defined as no pain, and 10 as the most severe pain imaginable.
Time Frame
Postoperative 24th hour
Secondary Outcome Measure Information:
Title
Analgesic consumption
Description
The value in mg of the amount of analgesic consumed in the postoperative period. It was administered with a PCA device that had regular infusions and was able to deliver bolus doses at regular intervals.
Time Frame
Postoperative 24th hour
Title
Postoperative nausea and vomiting
Description
The frequency of nausea and vomiting in the postoperative period was calculated according to the Numeric Rank Score (NRS), which ranged from 0 to 3. Nausea-vomiting status of the patients: 0 points if there is no nausea and vomiting; 1 point if there is nausea, no vomiting; It is scored as 2 points if there is vomiting once and 3 points if there are two or more vomiting attacks.
Time Frame
Postoperative 24th hour
Title
Chronic Pain
Description
Evaluation of shoulder pain level in terms of chronic pain in the postoperative period. It was evaluated using the VAS (Visual Analog Scala) score. The patients were followed up with a VAS score between 0-10 in the postoperative period. A VAS score of 0 was defined as no pain, and 10 as the most severe pain imaginable.
Time Frame
1 month after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ASA (American Society of Anesthesiologists) Classification I-II Anterior Cervical Disc and Fusion Surgery Exclusion Criteria: Patients with bleeding diathesis Neurological disease, BMI (Body Mass Index) less than 19 or greater than 30 The presence of infection in the neck area Patients who do not accept the procedure
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ergun Mendes
Phone
+905514265012
Email
erg.mendes@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ergun Mendes
Organizational Affiliation
Basaksehir Cam & Sakura Şehir Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ergun Mendes
City
Küçükçekmece
State/Province
İstanbul
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ergun Mendes
Phone
+9005514265012
Email
erg.mendes@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Individual participant data (IPD) will not be shared
Citations:
PubMed Identifier
32321860
Citation
Elsharkawy H, Ince I, Hamadnalla H, Drake RL, Tsui BCH. Cervical erector spinae plane block: a cadaver study. Reg Anesth Pain Med. 2020 Jul;45(7):552-556. doi: 10.1136/rapm-2019-101154. Epub 2020 Apr 21.
Results Reference
background
PubMed Identifier
25869024
Citation
Mariappan R, Mehta J, Massicotte E, Nagappa M, Manninen P, Venkatraghavan L. Effect of superficial cervical plexus block on postoperative quality of recovery after anterior cervical discectomy and fusion: a randomized controlled trial. Can J Anaesth. 2015 Aug;62(8):883-90. doi: 10.1007/s12630-015-0382-3. Epub 2015 Apr 14.
Results Reference
background

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Regional Analgesia for Anterior Cervical Disc and Fusion Surgery

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