Clinical trial NCT06157359: Effect of SNB on the QoR in Patients Undergoing Supratentorial Tumor Resection
Official title: Effect of Scalp Nerve Block on the Quality of Recovery in Patients Undergoing Supratentorial Tumor Resection
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Postoperative Analgesia
Quality of Recovery
Supratentorial Tumor
Craniotomy
Scalp Nerve Block
Keywords: Supratentorial tumor resection
Scalp nerve block
quality of recovery
postoperative analgesia
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2023-12-05
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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.


Eligibility criteria: Inclusion Criteria:

* 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;

Exclusion Criteria:

* 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;
* 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.

Primary outcomes:
measure: the 15-item QoR score at 24 hours after surgery
timeFrame: up to day1 after surgery
Secondary outcomes:
measure: the 15-item QoR score at 72 hours after surgery
timeFrame: up to day3 after surgery
measure: postoperative pain scores
timeFrame: up to day3 after surgery
measure: Riker Sedation-Agitation Scale
timeFrame: during in PACU, an average of 3 hours
measure: nausea and vomiting
timeFrame: up to day3 after surgery
measure: opioids and propofol consumption
timeFrame: during operation and in PACU, an average of 8 hours
measure: mean artery pressure and heart rate
timeFrame: during operation and in PACU, an average of 8 hours
measure: time to critical events
timeFrame: during hospitalization, an average of 10 days
measure: adverse events
timeFrame: up to day3 after surgery
measure: total medical expenses
timeFrame: during hospitalization, an average of 10 days
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Second affiliated Hospital School of Medicine,Zhejiang University
state: Zhejiang
Study officials:
References: