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Revision of Deep Brain Stimulator in Patients With Parkinson's Disease

Revision of Deep Brain Stimulator in Patients With Parkinson's Disease: A Comparison of Perioperative Characteristics of Regional and General Anesthesia

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07176494
Enrollment
50
Registered
2025-09-16
Start date
2025-09-20
Completion date
2026-07-20
Last updated
2025-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Deep Brain Stimulation, Pain Management, Parkinsons Disease, Regional Anesthesia

Keywords

Pectoserratus block, Interpektoral block, Deep brain stimulation, Awake surgery

Brief summary

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.

Interventions

PROCEDUREPatients who underwent surgery under general anesthesia

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.

PROCEDUREPatients who underwent surgery under regional anesthesia

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.

Sponsors

Ankara Etlik City Hospital
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
40 Years to 85 Years
Healthy volunteers
No

Inclusion criteria

* Those aged 40-85 * Those with an ASA score of I-II-III * Those with a body mass index (BMI) between 18-30

Exclusion criteria

* Those under 40 and over 85 * Those with an ASA score of IV or higher * Those with a BMI of under 18 and over 30

Design outcomes

Primary

MeasureTime frameDescription
Pain scoreup to 24 hoursPain 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.

Secondary

MeasureTime frameDescription
Patient Satisfactionpostoperative 24th hourPatient 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).
Need for additional analgesicspostoperative 24th hourAdditional analgesic need will be assessed

Countries

Turkey (Türkiye)

Contacts

Primary Contactİbrahim MD Topcu, MD
ibrahimtpc78@gmail.com05437860316
Backup ContactMusa MD Zengin
musazengin@gmail.com+905307716235

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026