Plexus Block;Analgesia;NeurosurgeryNCT04036812
Superficial Cervical Plexus Block for Postoperative Analgesia
A study testing Superficial cervical plexus block in people with Plexus Block;Analgesia;Neurosurgery, run by Beijing Tiantan Hospital at 2 sites in China.
Trial summary
The incidence of postoperative pain after craniotomy is high. Severe postoperative pain can lead to a series of complications that are detrimental to the recovery of craniotomy patients. 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 years
- Conditions the study is for
- Plexus Block;Analgesia;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
- 106 participants
- Where
- 2 sitesChina
- Study dates
- 18 Nov 2019to 10 Apr 2021
- 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
- No healthy volunteers
- 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 Tiantan Hospital
Beijing, Beijing Municipality, 100050
Beijing TianTan Hospital
Beijing, 100070
About this study
Official title: Ultrasound Guided Superficial Cervical Plexus Block for Analgesia After Craniotomy Via Suboccipital Retrosigmoid Approach: A Randomized Controlled Trial
The incidence of postoperative pain after craniotomy is high. Severe postoperative pain can lead to a series of complications that are detrimental to the recovery of craniotomy patients. 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 requirement of analgesic drugs and pain after craniotomy via suboccipital retrosigmoid approach.
- Conditions
- Plexus Block;Analgesia;Neurosurgery
- Being tested
- Superficial cervical plexus block, Control group
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
superficial cervical plexus nerve block will be performed under the guidance of ultrasound
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 |
|---|---|---|
| Superficial cervical plexus block group | Experimental | Not described Receives: Procedure: Superficial cervical plexus block |
| Control group | Sham comparator | Not described Receives: Other: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
the cumulative consumption of sufentanil by the PCA
the cumulative consumption of sufentanil by the PCA 24 hours after surgery
Measured: 24 hours after surgery
Secondary outcomes (4)
Use of analgesics by the PCA after operation
the cumulative consumption of sufentanil by PCA
Measured: at 1, 2, 4, 48 hours after surgery.
Pain severity score
It will be accessed using NRS
Measured: at 1, 2, 4, 24, 48 hours after surgery
Anesthesia recovery quality score：
It will be accessed at postoperative 1 and 2 hours using the Anesthesia Steward Emergence Scale. The Anesthesia Steward Emergence Scale(0-6) is divided into three parts: the degree of wakefulness - 2 points for complete recovery, 1 point for response to stimulation, 0 point for no response to stimulation; the degree of airway patency - 2 points for cough according to the doctor's order, 1 point for maintenance of airway patency without support, 0 point for support required for respiratory tract; 2 points for conscious activities of limbs with limb mobility, 1 point for unconscious activities of limbs, point for no activities of limbs.
Measured: at 1 hour after surgery
Patient analgesic satisfaction
Patient satisfaction with overall pain management will be evaluated at 24 hours after surgery using NRS
Measured: at 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2019
- Study start18 Nov 2019
- Primary completion9 Apr 2021
- Study completion10 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Plexus Block;Analgesia;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
- 106 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
- Investigators
- Yuming Peng, M.D., Principal investigator, Beijing Tian Tan Hospital, Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04036812
- Sponsor's protocol ID
- 2019-06-29
- Status last verified
- Feb 2025
- First submitted
- 26 Jul 2019
- Last updated
- 13 Feb 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zeng M, Li R, Xu X, Wang D, Dong J, Li S, Kass IS, Peng Y, Jia W. Ultrasound-guided superficial cervical plexus block reduces opioid consumption in patients undergoing craniotomy via suboccipital retrosigmoid approach: a randomized controlled trial. Reg Anesth Pain Med. 2022 Jun 29:rapm-2022-103534. doi: 10.1136/rapm-2022-103534. Online ahead of print.
PubMed 35768167Peng K, Zeng M, Dong J, Yan X, Wang D, Li S, Peng Y. Ultrasound-guided superficial cervical plexus block for analgesia in patients undergoing craniotomy via suboccipital retrosigmoid approach: study protocol of a randomised controlled trial. BMJ Open. 2020 Feb 5;10(2):e034003. doi: 10.1136/bmjopen-2019-034003.
PubMed 32029493
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Guided Superficial Cervical Plexus Block for Analgesia After Craniotomy Via Suboccipital Retrosigmoid Approach: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04036812
- Acronym / sponsor ID
- 2019-06-29
- Conditions
- Plexus Block;Analgesia;Neurosurgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Study start
- 18 Nov 2019 (actual)
- Primary completion
- 9 Apr 2021 (actual)
- Study completion
- 10 Apr 2021 (actual)
- First posted
- 30 Jul 2019 (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 pain after craniotomy is high. Severe postoperative pain can lead to a series of complications that are detrimental to the recovery of craniotomy patients. 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 requirement of analgesic drugs and 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 |
|---|---|---|
| Superficial cervical plexus block group | Experimental | Procedure: Superficial cervical plexus block |
| Control group | Sham comparator | Other: Control group |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not 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 blocksuperficial cervical plexus nerve block will be performed under the guidance of ultrasound | Procedure or surgery | Superficial cervical plexus block 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
the cumulative consumption of sufentanil by the PCA
Time frame: 24 hours after surgery
the cumulative consumption of sufentanil by the PCA 24 hours after surgery
4 secondary outcomes
Use of analgesics by the PCA after operation
Time frame: at 1, 2, 4, 48 hours after surgery.
Pain severity score
Time frame: at 1, 2, 4, 24, 48 hours after surgery
Anesthesia recovery quality score：
Time frame: at 1 hour after surgery
Patient analgesic satisfaction
Time frame: at 24 hours 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 13 Feb 2025.
- Derived from this study: PubMed 35768167Zeng M, Li R, Xu X, Wang D, Dong J, Li S, Kass IS, Peng Y, Jia W. Ultrasound-guided superficial cervical plexus block reduces opioid consumption in patients undergoing craniotomy via suboccipital retrosigmoid approach: a randomized controlled trial. Reg Anesth Pain Med. 2022 Jun 29:rapm-2022-103534. doi: 10.1136/rapm-2022-103534. Online ahead of print.
- Derived from this study: PubMed 32029493Peng K, Zeng M, Dong J, Yan X, Wang D, Li S, Peng Y. Ultrasound-guided superficial cervical plexus block for analgesia in patients undergoing craniotomy via suboccipital retrosigmoid approach: study protocol of a randomised controlled trial. BMJ Open. 2020 Feb 5;10(2):e034003. doi: 10.1136/bmjopen-2019-034003.
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.
Yuming Peng, M.D. principal investigator
Beijing Tian Tan Hospital, Capital Medical University
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 Plexus Block;Analgesia;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 13 Feb 2025. 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?
the cumulative consumption of sufentanil by the PCA (time frame: 24 hours 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 NCT04036812, which also lists 2 linked publications.
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 13 Feb 2025.