NeurosurgeryNCT05108337
Superficial Cervical Plexus Block for Postoperative Chronic Pain
A study testing Superficial cervical plexus block in people with Neurosurgery, run by Beijing Tiantan Hospital at 2 sites in China.
Trial summary
The incidence of postoperative chronic pain after craniotomy is high. Postoperative chronic pain seriously affects patient's quality of life. Compound local scalp nerve block is a good choice for analgesia after craniotomy. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Neurosurgery
- What is being tested?
- Superficial cervical plexus block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 292 participants
- Where
- 2 sitesChina
- Study dates
- 4 Nov 2021to 22 Nov 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Elective suboccipital retrosigmoid approach approach craniotomy;
- Age between 18 and 65 years;
- American Society of Anesthesiologists (ASA) physical status I-III.
Who cannot join
- The patients or legal clients refuse to provide informed consent;
- Local infection;
- Preoperative impairment of consciousness and cognitive function;
- Uncontrolled hypertension;
- Inability to communicate;
- Allergies to experimental drugs;
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- History of drug abuse;
- History of chronic headache;
- Aphasia and hearing impairment;
- Patients undergoing second craniotomy;
- Body mass index < 18.5 kg/m2 or > 35.0 kg/m2;
Trial locations and contacts
2 sites in 1 country.
China2 sites
Beijing Tian Tan Hospital, Capital Medical University
Beijing, Beijing Municipality, 100070
Beijing Tiantan Hospital
Beijing, Beijing Municipality, 100070
About this study
Official title: Ultrasound Guided Superficial Cervical Plexus Block for Chronic Pain After Craniotomy Via Suboccipital Retrosigmoid Approach: A Randomized Controlled Trial
The incidence of postoperative chronic pain after craniotomy is high. Postoperative chronic pain seriously affects patient's quality of life. Compound local scalp nerve block is a good choice for analgesia after craniotomy. However, the scalp nerve block commonly cannot cover the area of suboccipital retrosigmoid approach craniotomy, leading to incomplete block. Superficial cervical plexus block (SCPB) is theoretically promising to solve the analgesia requirements of such surgical approach. At the same time, ultrasound guidance can not only accurately locate, ensure the effect of block and avoid accidental injury during puncture. The purpose of this study is to explore whether ultrasound-guided superficial cervical plexus block can safely and effectively reduce the incidence of chronic pain after craniotomy via suboccipital retrosigmoid approach.
- Conditions
- Neurosurgery
- Being tested
- Superficial cervical plexus block, Control group
- Keywords
- Cervical Plexus Block, Chronic pain, Neurosurgery
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Superficial cervical plexus blockProcedure or surgery
Ultrasound guidance will be used to determine the location of superficial cervical plexus nerve. The puncture will also be performed by ultrasound guidance, covered with opaque infusion dressing but performed with infusion of 10 ml 0.5% ropinacaine.
Control groupOther
Ultrasound guidance will be used to determine the location of superficial cervical plexus nerve. The puncture will also be performed by ultrasound guidance, covered with opaque infusion dressing but performed with infusion of 10 ml normal saline.
| Study group | Role | What they receive |
|---|---|---|
| Scpb group | Experimental | Superficial cervical plexus block group Receives: Procedure: Superficial cervical plexus block |
| Control group | Sham comparator | Saline group Receives: Other: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chronic pain assessment
Follow-up visit will be conducted by telephone at 3 months after surgery.
Measured: at 3 months after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2021
- Study start4 Nov 2021
- Primary completion22 Nov 2023
- Study completion22 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeurosurgeryStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 292 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yuming Peng, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05108337
- Sponsor's protocol ID
- 2021-10-16
- Status last verified
- Jan 2024
- First submitted
- 21 Oct 2021
- Last updated
- 23 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Guided Superficial Cervical Plexus Block for Chronic Pain After Craniotomy Via Suboccipital Retrosigmoid Approach: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05108337
- Acronym / sponsor ID
- 2021-10-16
- Conditions
- Neurosurgery
- Keywords
- Cervical Plexus Block, Chronic pain, Neurosurgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 292 participants (actual)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Study start
- 4 Nov 2021 (actual)
- Primary completion
- 22 Nov 2023 (actual)
- Study completion
- 22 Nov 2023 (actual)
- First posted
- 4 Nov 2021 (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.
The incidence of postoperative chronic pain after craniotomy is high. Postoperative chronic pain seriously affects patient's quality of life. Compound local scalp nerve block is a good choice for analgesia after craniotomy. However, the scalp nerve block commonly cannot cover the area of suboccipital retrosigmoid approach craniotomy, leading to incomplete block. Superficial cervical plexus block (SCPB) is theoretically promising to solve the analgesia requirements of such surgical approach. At the same time, ultrasound guidance can not only accurately locate, ensure the effect of block and avoid accidental injury during puncture. The purpose of this study is to explore whether ultrasound-guided superficial cervical plexus block can safely and effectively reduce the incidence of chronic pain after craniotomy via suboccipital retrosigmoid approach.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Scpb group | Experimental | Procedure: Superficial cervical plexus blockSuperficial cervical plexus block group |
| Control group | Sham comparator | Other: Control groupSaline group |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Elective suboccipital retrosigmoid approach approach craniotomy;
- Age between 18 and 65 years;
- American Society of Anesthesiologists (ASA) physical status I-III.
Key exclusion criteria (11 listed)
- The patients or legal clients refuse to provide informed consent;
- Local infection;
- Preoperative impairment of consciousness and cognitive function;
- Uncontrolled hypertension;
- Inability to communicate;
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 |
|---|---|---|
| Superficial cervical plexus blockUltrasound guidance will be used to determine the location of superficial cervical plexus nerve. The puncture will also be performed by ultrasound guidance, covered with opaque infusion dressing but performed with infusion of 10 ml 0.5% ropinacaine. | Procedure or surgery | Scpb group |
| Control groupUltrasound guidance will be used to determine the location of superficial cervical plexus nerve. The puncture will also be performed by ultrasound guidance, covered with opaque infusion dressing but performed with infusion of 10 ml normal saline. | Other | Control group |
Primary outcome
Chronic pain assessment
Time frame: at 3 months after surgery.
Follow-up visit will be conducted by telephone at 3 months after surgery.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Superficial cervical plexus block in people with Neurosurgery, run by Beijing Tiantan Hospital at 2 sites 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 3 inclusion and 11 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: finished, as of the sponsor's last update on 23 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Chronic pain assessment (time frame: at 3 months after surgery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Jan 2024; AzTrials last refreshed its copy on 30 Oct 2026.