Regional Analgesia for Anterior Cervical Disc and Fusion Surgery

NCT05680142 | Completed

• 2 other identifiers: Interventional2023.06.232
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Secondary Outcomes (3)

• Analgesic consumption

  Postoperative 24th hour

• Postoperative nausea and vomiting

  Postoperative 24th hour

• Chronic Pain

  1 month after surgery

Study Arms (2)

Group sCPB

ACTIVE COMPARATOR

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

Drug: superficial cervical plexus block

Group cESP

ACTIVE COMPARATOR

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

Drug: cervical erector spinae plane block

Interventions

superficial cervical plexus block 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.

Also known as: sCPB

Group sCPB

cervical erector spinae plane block 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.

Also known as: cESP

Group cESP

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA (American Society of Anesthesiologists) Classification I-II
• Anterior Cervical Disc and Fusion Surgery

You may not qualify if:

• 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

Sponsors & Collaborators

• Başakşehir Çam & Sakura City Hospital: lead

Study Sites (1)

Ergun Mendes

Küçükçekmece, Istanbul, Turkey (Türkiye)

Location

Related Publications (2)

• 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.

  PMID: 32321860 BACKGROUND

• 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.

  PMID: 25869024 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative; Shoulder Pain; Intervertebral Disc Displacement

Interventions

small cardioactive peptide B

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Arthralgia; Joint Diseases; Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Hernia; Pathological Conditions, Anatomical

Study Officials

• Ergun Mendes

  Başakşehir Çam & Sakura City Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Specialist Doctor

Model Details: 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.

Study Record Dates

• First Submitted: November 22, 2022
• First Posted: January 11, 2023
• Study Start: July 6, 2023
• Primary Completion: May 14, 2024
• Study Completion: May 14, 2024
• Last Updated: May 16, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)