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| ID | Type | Description | Link |
|---|---|---|---|
| 2023.06.232 | Other Identifier | Basaksehir Cam and Sakura City Hospital |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group sCPB | Active Comparator | Superficial cervical plexus block, patients who applied sCPB for postoperative pain |
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| Group cESP | Active Comparator | Cervical erector spinae plane block, patients who applied cervical ESP block for postoperative pain |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Analgesic consumption | The value in mg of the amount of analgesic consumed in the postoperative period. It was administered with a PCA device that had regular infusions and was able to deliver bolus doses at regular intervals. | Postoperative 24th hour |
| Postoperative nausea and vomiting |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ergun Mendes | Başakşehir Çam & Sakura City Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ergun Mendes | Küçükçekmece | Istanbul | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32321860 | Background | 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. | |
| 25869024 | 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. |
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Individual participant data (IPD) will not be shared
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D020069 | Shoulder Pain |
| D007405 | Intervertebral Disc Displacement |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| C041307 | small cardioactive peptide B |
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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.
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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.
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| 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. |
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The frequency of nausea and vomiting in the postoperative period was calculated according to the Numeric Rank Score (NRS), which ranged from 0 to 3. Nausea-vomiting status of the patients: 0 points if there is no nausea and vomiting; 1 point if there is nausea, no vomiting; It is scored as 2 points if there is vomiting once and 3 points if there are two or more vomiting attacks. |
| Postoperative 24th hour |
| Chronic Pain | Evaluation of shoulder pain level in terms of chronic pain in the postoperative period. It was evaluated using the 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. | 1 month after surgery |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D018771 | Arthralgia |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |