Parkinson DiseaseNCT05353764
Effect of Scalp Nerve Block on the Recovery Quality of Parkinson's Patients After Deep Brain Stimulation
A study testing scalp nerve block combined with intercostal nerve block using 0.5% ropivacaine in people with Parkinson Disease, run by Changhai Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- scalp nerve block combined with intercostal nerve block using 0.5% ropivacaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteChina
- Study dates
- 20 Apr 2022to 1 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Changhai Hospital
Shanghai, Shanghai Municipality, 200433
Wenbin Lu, 13004162573, 13004162573@163.com
Xiya Yu, M.D, 13764210333, yuxiyash@163.com
About this study
Official title: Effect of Scalp Nerve Block Combined With Intercostal Nerve Block on Quality of Recovery After Deep Brain Stimulation in Patients With Parkinson's Disease
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.
- Conditions
- Parkinson Disease
- Being tested
- scalp nerve block combined with intercostal nerve block using 0.5% ropivacaine
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
scalp nerve block combined with intercostal nerve block using 0.5% ropivacaineOther
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.
| Study group | Role | What they receive |
|---|---|---|
| SNB group | Experimental | patients in the SNB group will receive general anesthesia combined with scalp nerve block and intercostal nerve block with 0.5% ropivacaine. Receives: Other: scalp nerve block combined with intercostal nerve block using 0.5% ropivacaine |
| control group | No intervention | patients in control group will receive general anesthesia without nerve block. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The 15-item QoR score
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
Measured: 24 hour after surgery
Secondary outcomes (4)
The 15-item QoR score
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
Measured: 72 hour and 1 month after surgery
The NRS score
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"
Measured: before discharge from PACU, at 24 hour, 72 hour and 1 month after surgery
The patients with PONV
postoperative nausea and vomiting
Measured: 24 hour after surgery
Consumption of opioid
The consumption of opioid reffers to remifentanil consumption
Measured: during operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2022
- Study start20 Apr 2022
- Primary completion1 Mar 2023 (estimated)
- Study completion1 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Changhai HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wen-bin Lu, MD, Changhai Hospital
- Investigators
- Xiya Yu, M.D, Principal investigator, Changhai hospital, Shanghai, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05353764
- Sponsor's protocol ID
- SNB-QoR
- Status last verified
- Jun 2022
- First submitted
- 19 Apr 2022
- Last updated
- 24 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Sheng Y, Wang H, Chang X, Jin P, Lin S, Qian S, Xie J, Lu W, Yu X. Effect of Scalp Nerve Block Combined with Intercostal Nerve Block on the Quality of Recovery in Patients with Parkinson's Disease after Deep Brain Stimulation: Protocol for a Randomized Controlled Trial. Brain Sci. 2022 Jul 29;12(8):1007. doi: 10.3390/brainsci12081007.
PubMed 36009070
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Scalp Nerve Block Combined With Intercostal Nerve Block on Quality of Recovery After Deep Brain Stimulation in Patients With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT05353764
- Acronym / sponsor ID
- SNB-QoR
- Conditions
- Parkinson Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Study start
- 20 Apr 2022 (actual)
- Primary completion
- 1 Mar 2023 (estimated)
- Study completion
- 1 Mar 2023 (estimated)
- First posted
- 29 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SNB group | Experimental | Other: scalp nerve block combined with intercostal nerve block using 0.5% ropivacainepatients in the SNB group will receive general anesthesia combined with scalp nerve block and intercostal nerve block with 0.5% ropivacaine. |
| control group | No intervention | –patients in control group will receive general anesthesia without nerve block. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- Allergy to local anesthetics
- Pre-existing infection at block site
- Severe coagulopathy
- Pre-existing neuropathic pain condition
- Previous history of DBS surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| scalp nerve block combined with intercostal nerve block using 0.5% ropivacaineParticipants 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. | Other | SNB group |
Primary outcome
The 15-item QoR score
Time frame: 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
4 secondary outcomes
The 15-item QoR score
Time frame: 72 hour and 1 month after surgery
The NRS score
Time frame: before discharge from PACU, at 24 hour, 72 hour and 1 month after surgery
The patients with PONV
Time frame: 24 hour after surgery
Consumption of opioid
Time frame: during operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2022.
- Derived from this study: PubMed 36009070Sheng Y, Wang H, Chang X, Jin P, Lin S, Qian S, Xie J, Lu W, Yu X. Effect of Scalp Nerve Block Combined with Intercostal Nerve Block on the Quality of Recovery in Patients with Parkinson's Disease after Deep Brain Stimulation: Protocol for a Randomized Controlled Trial. Brain Sci. 2022 Jul 29;12(8):1007. doi: 10.3390/brainsci12081007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xiya Yu, M.D principal investigator
Changhai hospital, Shanghai, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing scalp nerve block combined with intercostal nerve block using 0.5% ropivacaine in people with Parkinson Disease, run by Changhai Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wenbin Lu (13004162573, 13004162573@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The 15-item QoR score (time frame: 24 hour after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05353764, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2022.