Regional Analgesia for Anterior Cervical Disc and Fusion Surgery

Not Applicable

Completed

• Conditions: Shoulder Pain; Disc Herniation; Anesthesia, Local; Postoperative Pain
• Interventions: Drug: superficial cervical plexus block; Drug: cervical erector spinae plane block

• Registration Number: NCT05680142
• Lead Sponsor: Başakşehir Çam & Sakura City Hospital

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.

Study Timeline

• Study First Submitted: 2022-11-22
• Study First Submitted QC: 2023-01-08
• Study First Posted: 2023-01-11
• Study Start: 2023-07-06
• Status Verified: 2024-05
• Primary Completion: 2024-05-14
• Study Completion: 2024-05-14
• Last Update Submitted: 2024-05-15
• Last Update Posted: 2024-05-16

Recruitment & Eligibility

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

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group sCPB	superficial cervical plexus block	Superficial cervical plexus block, patients who applied sCPB for postoperative pain
Group cESP	cervical erector spinae plane block	Cervical erector spinae plane block, patients who applied cervical ESP block for postoperative pain

Primary Outcome Measures

Name	Time	Method
Qualitif of Recovery-15 (QoR-15)	Postoperative 24th hour	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	Postoperative 24th hour	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

Name	Time	Method
Analgesic consumption	Postoperative 24th hour	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.
Chronic Pain	1 month after surgery	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.
Postoperative nausea and vomiting	Postoperative 24th hour	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.

Trial Locations

Locations (1)

Ergun Mendes; 🇹🇷 Küçükçekmece, İstanbul, Turkey