Effect of SNB on the QoR in Patients Undergoing Supratentorial Tumor Resection

Not Applicable

Recruiting

• Conditions: Postoperative Analgesia; Quality of Recovery; Craniotomy; Scalp Nerve Block; Supratentorial Tumor
• Interventions: Procedure: scalp nerve block

• Registration Number: NCT06157359
• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-11
• Study Start: 2023-11-14
• Study First Submitted: 2023-11-14
• Study First Submitted QC: 2023-11-27
• Study First Posted: 2023-12-05
• Last Update Submitted: 2024-08-07
• Last Update Posted: 2024-08-09
• Primary Completion: 2024-10-31
• Study Completion: 2024-10-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 84

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SNB group	scalp nerve block	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.

Primary Outcome Measures

Name	Time	Method
the 15-item QoR score at 24 hours after surgery	up to day1 after surgery	The quality of postoperative recovery is assessed by QoR-15 on the first day after operation.

Secondary Outcome Measures

Name	Time	Method
the 15-item QoR score at 72 hours after surgery	up to day3 after surgery	The quality of postoperative recovery is assessed by QoR-15 on the third day after operation.
Riker Sedation-Agitation Scale	during in PACU, an average of 3 hours	Riker Sedation-Agitation Scale is assessed at 2 time points: 20 minutes after extubation and discharge from PACU.
nausea and vomiting	up to day3 after surgery	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.
total medical expenses	during hospitalization, an average of 10 days	The total medical expenses is recorded during hospitalization.
postoperative pain scores	up to day3 after surgery	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.
opioids and propofol consumption	during operation and in PACU, an average of 8 hours	Total drug dose of sufentanil, remifentanil and propofol consumption is recorded during operation and in PACU.
time to critical events	during hospitalization, an average of 10 days	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.
mean artery pressure and heart rate	during operation and in PACU, an average of 8 hours	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).
adverse events	up to day3 after surgery	Adverse events within 72 hours after operation are recorded.

Trial Locations

Locations (1)

Second affiliated Hospital School of Medicine,Zhejiang University; 🇨🇳 Hangzhou, Zhejiang, China