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Clinical Trials/NCT05680142
NCT05680142
Completed
Not Applicable

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

Başakşehir Çam & Sakura City Hospital1 site in 1 country40 target enrollmentJuly 6, 2023

Overview

Phase
Not Applicable
Intervention
superficial cervical plexus block
Conditions
Postoperative Pain
Sponsor
Başakşehir Çam & Sakura City Hospital
Enrollment
40
Locations
1
Primary Endpoint
Qualitif of Recovery-15 (QoR-15)
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 6, 2023
End Date
May 14, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Başakşehir Çam & Sakura City Hospital
Responsible Party
Principal Investigator
Principal Investigator

Ergün Mendeş

Specialist Doctor

Başakşehir Çam & Sakura City Hospital

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

Arms & Interventions

Group sCPB

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

Intervention: superficial cervical plexus block

Group cESP

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

Intervention: cervical erector spinae plane block

Outcomes

Primary Outcomes

Qualitif of Recovery-15 (QoR-15)

Time Frame: 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

Time Frame: 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 Outcomes

  • Analgesic consumption(Postoperative 24th hour)
  • Chronic Pain(1 month after surgery)
  • Postoperative nausea and vomiting(Postoperative 24th hour)

Study Sites (1)

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