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Parkinson's disease is a chronic and progressive neurodegenerative disease that affects the central nervous system, particularly impairing movement control. It is associated with the loss of dopamine-producing cells in the brain and typically occurs in middle age and beyond. Deep brain stimulation (DBS) is considered when symptoms of Parkinson's disease, such as tremors, slowed movements, and muscle rigidity, are not adequately controlled with medications. Selected patients with severe symptoms that do not respond to medical treatment are generally considered for this treatment.
Battery revision surgeries can be performed under general anesthesia or regional anesthesia. Patients undergoing general anesthesia should be cautious about the potential complications of general anesthesia, while those undergoing regional anesthesia should be cautious about the local anesthetic systemic toxicity. Because each method has its own advantages, the choice of anesthesia may vary.
This study aimed to compare postoperative analgesic efficacy and patient satisfaction in patients who underwent surgery under general anesthesia or sedation-assisted battery replacement under regional anesthesia. Both anesthesia methods are routinely used in Parkinson's disease patients undergoing battery replacement.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients who underwent surgery under general anesthesia | Active Comparator | These patients will be operated on under general anesthesia. During the skin closure, patients received 50 mg of dexketoprofen. Additionally, a paracetamol dose of 1 g every 8 hours and a dexketoprofen dose of 50 mg twice daily were administered intravenously for multimodal analgesia. |
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| Patients who underwent surgery under regional anesthesia | Active Comparator | These patients will undergo surgery under regional anesthesia. Interpectoral and pectoserratus plane blocks will be applied to these patients. In the block group, bupivacaine and lidocaine are injected using an ultrasound-guided in-plane technique, between the 3rd and 4th ribs, into the interpectoral plane, and into the pectoserratus plane. 25 cc (15 cc 0.5% bupivacaine + 5 cc 2% lidocaine + 5 cc isotonic) local anesthetic solution is prepared. 10 cc of the medication is administered into the interpectoral plane, and 15 cc into the pectoserratus plane. During the skin closure, patients received 50 mg of dexketoprofen. Additionally, a paracetamol dose of 1 g every 8 hours and a dexketoprofen dose of 50 mg twice daily were administered intravenously for multimodal analgesia. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Patients who underwent surgery under general anesthesia | Procedure | Patients undergoing surgery under general anesthesia will undergo general anesthesia induction. During the skin closure, patients received 50 mg of dexketoprofen. Additionally, a paracetamol dose of 1 g every 8 hours and a dexketoprofen dose of 50 mg twice daily were administered intravenously for multimodal analgesia. |
| Measure | Description | Time Frame |
|---|---|---|
| Pain score | Pain will be assessed using a visual analog scale from 0 mm (no pain) to 100 mm (worst pain) at rest and when coughing. Pain assessment will be made at 0, 1, 6, 12, 18, and 24 hours after surgery. | up to 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Satisfaction | Patient satisfaction will be evaluated using a Likert scale.Evaluation will be made using a 5-point Likert scale (1= I am not satisfied at all - 5= I am very satisfied). | postoperative 24th hour |
| Need for additional analgesics |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| İbrahim MD Topcu, MD | Contact | 05437860316 | ibrahimtpc78@gmail.com | |
| Musa MD Zengin | Contact | +905307716235 | musazengin@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ankara Etlik City Hospital | Recruiting | Ankara | Yenimahalle\Ankara | 06170 | Turkey (Türkiye) |
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| Patients who underwent surgery under regional anesthesia | Procedure | 25 cc (15 cc 0.5% bupivacaine + 5 cc 2% lidocaine + 5 cc isotonic) local anesthetic solution is prepared. 10 cc of the medication is administered into the interpectoral plane, and 15 cc into the pectoserratus plane. During the skin closure, patients received 50 mg of dexketoprofen. Additionally, a paracetamol dose of 1 g every 8 hours and a dexketoprofen dose of 50 mg twice daily were administered intravenously for multimodal analgesia. |
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Additional analgesic need will be assessed
| postoperative 24th hour |
| ID | Term |
|---|---|
| D000377 | Agnosia |
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
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