Regional Analgesia for Anterior Cervical Disc and Fusion Surgery

NCT ID: NCT05680142

Last Updated: 2024-05-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-06
• Study Completion Date: 2024-05-14

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.

Conditions

Postoperative Pain; Shoulder Pain; Anesthesia, Local; Disc Herniation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Group sCPB

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

Group Type: ACTIVE_COMPARATOR

superficial cervical plexus block

Intervention Type: DRUG

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.

Group cESP

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

Group Type: ACTIVE_COMPARATOR

cervical erector spinae plane block

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

sCPB; cESP

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Başakşehir Çam & Sakura City Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Ergün Mendeş

Specialist Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ergun Mendes

Role: PRINCIPAL_INVESTIGATOR

Başakşehir Çam & Sakura City Hospital

Locations

Ergun Mendes

Küçükçekmece, Istanbul, Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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.

Reference Type: BACKGROUND

PMID: 32321860 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25869024 (View on PubMed)

Other Identifiers

2023.06.232

Identifier Type: OTHER

Identifier Source: secondary_id

Interventional

Identifier Type: -

Identifier Source: org_study_id