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

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.

Study Overview

• Status: Recruiting
• Conditions: Craniotomy; Quality of Recovery; Postoperative Analgesia; Scalp Nerve Block; Supratentorial Tumor
• Intervention / Treatment: Procedure: scalp nerve block

• Study Type: Interventional
• Enrollment (Estimated): 84
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lina Yu, doctor; Phone Number: +8613958033387; Email: zryulina@zju.edu.cn

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China
      • Recruiting
      • Second affiliated Hospital School of Medicine,Zhejiang University
      • Contact: Lina Yu, doctor; Phone Number: +8613958033387; Email: zryulina@zju.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: control group; Patients in the control group will receive general anesthesia without the nerve blocks.
Experimental: SNB group; 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.; Other Names: 0.75% ropivacaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	up to day1 after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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).	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.	during hospitalization, an average of 10 days
adverse events	Adverse events within 72 hours after operation are recorded.	up to day3 after surgery
total medical expenses	The total medical expenses is recorded during hospitalization.	during hospitalization, an average of 10 days

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Study record dates

Study Major Dates

• Study Start (Estimated): November 27, 2023
• Primary Completion (Estimated): October 31, 2024
• Study Completion (Estimated): October 31, 2024

Study Registration Dates

• First Submitted: November 14, 2023
• First Submitted That Met QC Criteria: November 27, 2023
• First Posted (Estimated): December 5, 2023

Study Record Updates

• Last Update Posted (Estimated): December 5, 2023
• Last Update Submitted That Met QC Criteria: November 27, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: quality of recovery; postoperative analgesia; Scalp nerve block; Supratentorial tumor resection
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms; Neoplasms by Site; Brain Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Supratentorial Neoplasms; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Ropivacaine
• Other Study ID Numbers: 2023-0826

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No