Regional Analgesia for Anterior Cervical Disc and Fusion Surgery

Efficacy of Cervical Erector Spina Plane Block and Superficial Cervical Plexus Block in Anterior Cervical Disc and Fusion Surgery

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Pain; Anesthesia, Local; Shoulder Pain; Disc Herniation
• Intervention / Treatment: Drug: superficial cervical plexus block; Drug: cervical erector spinae plane block

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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • İstanbul
    • Küçükçekmece, İstanbul, Turkey
      • Ergun Mendes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Study Population

In this study, 40 ASA I-II patients aged 18-65 years who will undergo elective C5 or C6 level Anterior Cervical Disc and Fusion Surgery under elective conditions in our hospital were included.

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group sCPB; Superficial cervical plexus block, patients who applied sCPB for postoperative pain	Drug: superficial cervical plexus block; 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.; Other Names: sCPB
Active Comparator: Group cESP; Cervical erector spinae plane block, patients who applied cervical ESP block for postoperative pain	Drug: cervical erector spinae plane block; 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.; Other Names: cESP

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Postoperative 24th hour
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	Postoperative 24th hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 24th hour
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.	Postoperative 24th hour
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.	1 month after surgery

Collaborators and Investigators

• Sponsor: Başakşehir Çam & Sakura City Hospital
• Investigators: Principal Investigator: Ergun Mendes, Başakşehir Çam & Sakura City Hospital

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 6, 2023
• Primary Completion (Actual): May 14, 2024
• Study Completion (Actual): May 14, 2024

Study Registration Dates

• First Submitted: November 22, 2022
• First Submitted That Met QC Criteria: January 8, 2023
• First Posted (Actual): January 11, 2023

Study Record Updates

• Last Update Posted (Actual): May 16, 2024
• Last Update Submitted That Met QC Criteria: May 15, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: cervical erector spinae block; anterior cervical disc and fusion surgery; postoperative analgesic consumption; superficial cervical plexus block
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Joint Diseases; Musculoskeletal Diseases; Pathological Conditions, Anatomical; Spinal Diseases; Bone Diseases; Arthralgia; Hernia; Intervertebral Disc Displacement; Shoulder Pain; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Tramadol
• Other Study ID Numbers: Interventional (Oncolys BioPharma Inc); 2023.06.232 (Other Identifier: Basaksehir Cam and Sakura City Hospital)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data (IPD) will not be shared

Drug and device information, study documents

• 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