Effect of Scalp Nerve Block on the Quality of Recovery in Patients Undergoing Supratentorial Tumor Resection
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Postoperative Analgesia
- Sponsor
- Second Affiliated Hospital, School of Medicine, Zhejiang University
- Enrollment
- 84
- Locations
- 1
- Primary Endpoint
- the 15-item QoR score at 24 hours after surgery
- Status
- Recruiting
- Last Updated
- last year
Overview
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.
Investigators
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;
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- postoperative pain scores(up to day3 after surgery)
- opioids and propofol consumption(during operation and in PACU, an average of 8 hours)
- time to critical events(during hospitalization, an average of 10 days)
- the 15-item QoR score at 72 hours after surgery(up to day3 after surgery)
- Riker Sedation-Agitation Scale(during in PACU, an average of 3 hours)
- nausea and vomiting(up to day3 after surgery)
- total medical expenses(during hospitalization, an average of 10 days)
- mean artery pressure and heart rate(during operation and in PACU, an average of 8 hours)
- adverse events(up to day3 after surgery)