Parkinson Disease
Conditions
Brief summary
Patients diagnosed with Parkinson's disease (PD) undergoing deep Brain Stimulation (DBS) have a higher risk of perioperative complications and postoperative pain will affect quality of recovery (QoR) resulting in longer hospitalization time and higher hospital costs. Scalp nerve block (SNB) combined with intercostal nerve block (ICNB)can alleviate postoperative pain while effect of them on postoperative recovery quality of patients diagnosed with PD was unclear. Therefore, the investigators conducted a randomized controlled trails to provide a novel method for enhanced recovery and early prevention and treatment of acute pain after DBS surgery.
Interventions
OTHERscalp nerve block combined with intercostal nerve block using 0.5% ropivacaine
Participants randomized to the SNB group will receive general anesthesia combined with scalp nerve block and intercostal nerve block with 0.5% ropivacaine, which was performed exclusively by an attending anesthesiologist.An attending anesthesiologist will select the site of SNB based on the surgical incision site. Scalp nerve was blocked including greater occipital nerve (2-3ml), superficial temporal nerve (2-3ml), trochlear nerve (2-3ml) and supraorbital nerve (2-3ml). The total volume in scalp nerve block will not exceed 10 ml.Ultrasound-guided unilateral ICNB will be performed at the level of T4-T5 next to the sternum.10-15ml of 0.5% ropivacaine will be injected into the intercostal spaces where incision locates after negative aspiration.
Sponsors
Changhai Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* patients with PD who receive elective deep brain stimulation (DBS) surgery * Aged ≥ 18 * American Society of Anesthesiologists (ASA) physical status of I-III * Able to communicate normally
Exclusion criteria
* Allergy to local anesthetics * Pre-existing infection at block site * Severe coagulopathy * Pre-existing neuropathic pain condition * Previous history of DBS surgery * unwilling to provide informed consent or poor compliance
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The 15-item QoR score | 24 hour after surgery | The 15-item QoR score is used to asses quality of recovery after surgery which ranges 0-150 and higher QoR-15 scores indicate better postoperative recovery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The 15-item QoR score | 72 hour and 1 month after surgery | The 15-item QoR score is used to asses quality of recovery after surgery which ranges 0-150 and higher QoR-15 scores indicate better postoperative recovery |
| The NRS score | before discharge from PACU, at 24 hour, 72 hour and 1 month after surgery | Postoperative pain will be quantified using the NRS ranging from 0 to 10, where 0 means no pain at all and 10 means the worst pain imaginable |
| The patients with PONV | 24 hour after surgery | postoperative nausea and vomiting |
| Consumption of opioid | during operation | The consumption of opioid reffers to remifentanil consumption |
Countries
China
Contacts
Primary ContactWenbin Lu
Backup ContactXiya Yu, M.D
Outcome results
None listed