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Regional Analgesia for Anterior Cervical Disc and Fusion Surgery

B

Başakşehir Çam & Sakura City Hospital

Status

Completed

Conditions

Postoperative Pain
Shoulder Pain
Disc Herniation
Anesthesia, Local

Treatments

Drug: superficial cervical plexus block
Drug: cervical erector spinae plane block

Study type

Interventional

Funder types

Other

Identifiers

NCT05680142
Interventional (Other Identifier)
2023.06.232 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

40 participants in 2 patient groups

Group sCPB
Active Comparator group
Description:
Superficial cervical plexus block, patients who applied sCPB for postoperative pain
Treatment:
Drug: superficial cervical plexus block
Group cESP
Active Comparator group
Description:
Cervical erector spinae plane block, patients who applied cervical ESP block for postoperative pain
Treatment:
Drug: cervical erector spinae plane block

Trial contacts and locations

1

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Central trial contact

Ergun Mendes

Data sourced from clinicaltrials.gov

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