Clinical trial NCT05680142: Regional Analgesia for Anterior Cervical Disc and Fusion Surgery
Official title: Efficacy of Cervical Erector Spina Plane Block and Superficial Cervical Plexus Block in Anterior Cervical Disc and Fusion Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Başakşehir Çam & Sakura City Hospital
Sponsor class: OTHER_GOV
First posted: 2023-01-11
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Qualitif of Recovery-15 (QoR-15)
timeFrame: Postoperative 24th hour
measure: VAS (Visual Analog Scala) score
timeFrame: Postoperative 24th hour
Secondary outcomes:
measure: Analgesic consumption
timeFrame: Postoperative 24th hour
measure: Postoperative nausea and vomiting
timeFrame: Postoperative 24th hour
measure: Chronic Pain
timeFrame: 1 month after surgery
Other outcomes:
Locations:
city: Küçükçekmece
country: Turkey
facility: Ergun Mendes
state: İstanbul
Study officials:
affiliation: Başakşehir Çam & Sakura City Hospital
name: Ergun Mendes
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.