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

Ankara Etlik City Hospital

Status: Enrolling

Conditions: Pain Management; Deep Brain Stimulation; Parkinsons Disease; Regional Anesthesia

Treatments: Procedure: Patients who underwent surgery under general anesthesia; Procedure: Patients who underwent surgery under regional anesthesia

Study type: Interventional

Funder types: Other

Identifiers

NCT07176494

AnkaraEtlik1

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 40 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 2 patient groups

Patients who underwent surgery under general anesthesia

Active Comparator group

Description:

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.

Treatment:

Procedure: Patients who underwent surgery under general anesthesia

Patients who underwent surgery under regional anesthesia

Active Comparator group

Description:

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.

Treatment:

Procedure: Patients who underwent surgery under regional anesthesia