Postoperative AnalgesiaNCT06157359
Effect of SNB on the QoR in Patients Undergoing Supratentorial Tumor Resection
A study testing scalp nerve block in people with Postoperative Analgesia and Quality of Recovery, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
Patients with Supratentorial tumor undergoing craniotomy have a higher risk of postoperative pain, which will affect their postoperative quality of recovery (QoR). Although scalp nerve block (SNB) can alleviate postoperative pain, the effect on postoperative QoR in patients with supratentorial tumor undergoing… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Postoperative Analgesia, Quality of Recovery, Supratentorial Tumor
- What is being tested?
- scalp nerve block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteChina
- Study dates
- 14 Nov 2023to 31 Oct 2024
- 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
- age between 18 and 65;
- the diagnosis was supratentorial tumor;
- scheduled for elective supratentorial craniotomy with general anesthesia ;
- the American Society of Anesthesiologists physical status I-III;
Who cannot join
- the BMI≦18kg/m2 or BMI≧30kg/m2;
- refusing to sign written informed consent;
- anticipated surgery duration is too short (<2 h) or too long (>6 h);
- liver or kidney dysfunction, severe cardiopulmonary failure or nervous system disease ;
- with other malignancies ;
- severe hematological disease and / or abnormal coagulation function;
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- fever, systemic and / or scalp infection;
- tumors are metastases, aneurysms, hemangioma, or located in the skull base, or located in functional brain areas such as language and movement;
- allergy to any drug used in this study;
- a history of craniotomy tumor resection;
- preoperative usage of antiinflammatory agents or analgesics;
- pregnant women, lactating women, illiterate people, people with cognitive impairment, a history of mental illness, unable to communicate and complete the scale assessment;
- patients with severe hemodynamic disturbances or other life-threatening complications during the operation, or those transferred to the intensive care unit (ICU) after surgery.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Second affiliated Hospital School of Medicine,Zhejiang University
Hangzhou, Zhejiang
Lina Yu, doctor, +8613958033387, zryulina@zju.edu.cn
About this study
Official title: Effect of Scalp Nerve Block on the Quality of Recovery in Patients Undergoing Supratentorial Tumor Resection
Patients with Supratentorial tumor undergoing craniotomy have a higher risk of postoperative pain, which will affect their postoperative quality of recovery (QoR). Although scalp nerve block (SNB) can alleviate postoperative pain, the effect on postoperative QoR in patients with supratentorial tumor undergoing craniotomy is still unclear. This study is aimed to explore the effect of SNB on postoperative QoR in this population. To explore the effect, we design a randomized controlled trial in which 84 patients with supratentorial tumor will be randomly assigned to either the SNB group or control group. The primary outcome is 15-item QoR score at 24 h after surgery. The secondary outcomes include 15-item QoR scores at 72 h after surgery, Riker Sedation-Agitation Scale, nausea and vomiting, intraoperative opioids and propofol consumption, perioperative heart rate and mean artery pressure, the duration of anesthesia and surgery, time to extubation, PACU duration, the length of postoperative days, adverse events within 72h and total medical expenses.
- Conditions
- Postoperative Analgesia, Quality of Recovery, Supratentorial Tumor, Craniotomy, Scalp Nerve Block
- Being tested
- scalp nerve block
- Keywords
- Supratentorial tumor resection, Scalp nerve block, quality of recovery, postoperative analgesia
- Medical subject headings
- Supratentorial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
scalp nerve blockProcedure or surgery
Also called 0.75% ropivacaine
In the SNB group, bilateral scalp nerve blocks will performed using 20 mL of 0.75% ropivacaine after anesthesia induction. To cover the area of surgical incision and skull clamp, seven scalp nerves including the supratrochlear, supraorbital, zygomaticotemporal, auriculotemporal, lesser occipital and greater occipital nerves, are blocked bilaterally by injecting 1-2 ml of the solution using a 25-gauge needle.
| Study group | Role | What they receive |
|---|---|---|
| control group | No intervention | Patients in the control group will receive general anesthesia without the nerve blocks. |
| SNB group | Experimental | Participants randomized to the SNB group will receive general anesthesia combined with SNB using 0.75% ropivacaine, which will be performed by the same attending anesthesiologist. Receives: Procedure: scalp nerve block |
What is being measured
The primary outcome is the main question the study is designed to answer.
the 15-item QoR score at 24 hours after surgery
The quality of postoperative recovery is assessed by QoR-15 on the first day after operation.
Measured: up to day1 after surgery
Secondary outcomes (9)
the 15-item QoR score at 72 hours after surgery
The quality of postoperative recovery is assessed by QoR-15 on the third day after operation.
Measured: up to day3 after surgery
postoperative pain scores
Pain intensity is evaluated with the numerical rating scale (0-10, 0 = no pain, 10 = unbearable pain) at 6 time points: 20 minutes after extubation, discharge from PACU, 6 hours, 12 hours, 24 hours, and 72 hours following surgery. The worst pain score during each interval is recorded.
Measured: up to day3 after surgery
Riker Sedation-Agitation Scale
Riker Sedation-Agitation Scale is assessed at 2 time points: 20 minutes after extubation and discharge from PACU.
Measured: during in PACU, an average of 3 hours
nausea and vomiting
Nausea and vomiting is assessed by postoperative nausea and vomiting score (0, no nausea or vomiting; 1, nausea but no vomiting; 2, vomiting once or twice; 3, vomiting on more than two occasions) at 3 time points: discharge from PACU, 24 hours, and 72 hours after operation.
Measured: up to day3 after surgery
opioids and propofol consumption
Total drug dose of sufentanil, remifentanil and propofol consumption is recorded during operation and in PACU.
Measured: during operation and in PACU, an average of 8 hours
mean artery pressure and heart rate
Mean artery pressure and heart rate are recorded at 6 time points: before anesthesia induction (T0), after placement of the skull clamp (T1), beginning of surgery (T2), end of surgery (T3), 20 minutes after extubation (T4) , and discharge from PACU (T5).
Measured: during operation and in PACU, an average of 8 hours
time to critical events
The time to critical events are recorded, including the duration of anesthesia and surgery, time to extubation, PACU duration, postoperative hospital days and so on.
Measured: during hospitalization, an average of 10 days
adverse events
Adverse events within 72 hours after operation are recorded.
Measured: up to day3 after surgery
total medical expenses
The total medical expenses is recorded during hospitalization.
Measured: during hospitalization, an average of 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2023
- Study start14 Nov 2023
- Primary completion31 Oct 2024 (estimated)
- Study completion31 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative AnalgesiaStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06157359
- Sponsor's protocol ID
- 2023-0826
- Status last verified
- Nov 2023
- First submitted
- 14 Nov 2023
- Last updated
- 9 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Scalp Nerve Block on the Quality of Recovery in Patients Undergoing Supratentorial Tumor Resection
- ClinicalTrials.gov ID
- NCT06157359
- Acronym / sponsor ID
- 2023-0826
- Conditions
- Postoperative Analgesia, Quality of Recovery, Supratentorial Tumor, Craniotomy, Scalp Nerve Block
- Keywords
- Supratentorial tumor resection, Scalp nerve block, quality of recovery, postoperative analgesia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 14 Nov 2023 (actual)
- Primary completion
- 31 Oct 2024 (estimated)
- Study completion
- 31 Oct 2024 (estimated)
- First posted
- 5 Dec 2023 (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 with Supratentorial tumor undergoing craniotomy have a higher risk of postoperative pain, which will affect their postoperative quality of recovery (QoR). Although scalp nerve block (SNB) can alleviate postoperative pain, the effect on postoperative QoR in patients with supratentorial tumor undergoing craniotomy is still unclear. This study is aimed to explore the effect of SNB on postoperative QoR in this population. To explore the effect, we design a randomized controlled trial in which 84 patients with supratentorial tumor will be randomly assigned to either the SNB group or control group. The primary outcome is 15-item QoR score at 24 h after surgery. The secondary outcomes include 15-item QoR scores at 72 h after surgery, Riker Sedation-Agitation Scale, nausea and vomiting, intraoperative opioids and propofol consumption, perioperative heart rate and mean artery pressure, the duration of anesthesia and surgery, time to extubation, PACU duration, the length of postoperative days, adverse events within 72h and total medical expenses.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | No intervention | –Patients in the control group will receive general anesthesia without the nerve blocks. |
| SNB group | Experimental | Procedure: scalp nerve blockParticipants randomized to the SNB group will receive general anesthesia combined with SNB using 0.75% ropivacaine, which will be performed by the same attending anesthesiologist. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age between 18 and 65;
- the diagnosis was supratentorial tumor;
- scheduled for elective supratentorial craniotomy with general anesthesia ;
- the American Society of Anesthesiologists physical status I-III;
Key exclusion criteria (13 listed)
- the BMI≦18kg/m2 or BMI≧30kg/m2;
- refusing to sign written informed consent;
- anticipated surgery duration is too short (<2 h) or too long (>6 h);
- liver or kidney dysfunction, severe cardiopulmonary failure or nervous system disease ;
- with other malignancies ;
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 blockAlso: 0.75% ropivacaineIn the SNB group, bilateral scalp nerve blocks will performed using 20 mL of 0.75% ropivacaine after anesthesia induction. To cover the area of surgical incision and skull clamp, seven scalp nerves including the supratrochlear, supraorbital, zygomaticotemporal, auriculotemporal, lesser occipital and greater occipital nerves, are blocked bilaterally by injecting 1-2 ml of the solution using a 25-gauge needle. | Procedure or surgery | SNB group |
Primary outcome
the 15-item QoR score at 24 hours after surgery
Time frame: up to day1 after surgery
The quality of postoperative recovery is assessed by QoR-15 on the first day after operation.
9 secondary outcomes
the 15-item QoR score at 72 hours after surgery
Time frame: up to day3 after surgery
postoperative pain scores
Time frame: up to day3 after surgery
Riker Sedation-Agitation Scale
Time frame: during in PACU, an average of 3 hours
nausea and vomiting
Time frame: up to day3 after surgery
opioids and propofol consumption
Time frame: during operation and in PACU, an average of 8 hours
mean artery pressure and heart rate
Time frame: during operation and in PACU, an average of 8 hours
time to critical events
Time frame: during hospitalization, an average of 10 days
adverse events
Time frame: up to day3 after surgery
total medical expenses
Time frame: during hospitalization, an average of 10 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2024.
- Individual participant dataSharing planned: No
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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.
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 in people with Postoperative Analgesia and Quality of Recovery, run by Second Affiliated Hospital, Zhejiang University, School of Medicine 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 13 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 9 Aug 2024. 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 Lina Yu, doctor (+8613958033387, zryulina@zju.edu.cn), 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 at 24 hours after surgery (time frame: up to day1 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 9 Aug 2024.