An interventional study of scalp nerve block in Postoperative Analgesia, Quality of Recovery and Supratentorial Tumor, sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University. Recruiting at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-08-09.
Sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University · Not applicable, Interventional, and Treatment
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.
22 studies on the registry are indexed under Supratentorial Neoplasms; 3 are open to participants now.
This study's planned enrollment of 84 is close to the median of 80 across 20 interventional studies indexed under Supratentorial Neoplasms.
Browse Supratentorial Neoplasms studies →Second Affiliated Hospital, School of Medicine, Zhejiang University is the lead sponsor of 1,047 studies on the registry; 502 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients in the control group will receive general anesthesia without the nerve blocks.
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.
Procedure: scalp nerve block
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.
Also known as: 0.75% ropivacaine
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.
Time frame: up to day1 after surgery
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: during hospitalization, an average of 10 days
adverse events
Adverse events within 72 hours after operation are recorded.
Time frame: up to day3 after surgery
total medical expenses
The total medical expenses is recorded during hospitalization.
Time frame: during hospitalization, an average of 10 days
Plan to share: No
No publications or documents are linked to this record.
Started Nov 2023 (actual). Primary completion is estimated for Oct 2024, 11 months after the start.
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Second Affiliated Hospital, School of Medicine, Zhejiang University →