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

NCT ID: NCT06157359

Last Updated: 2024-08-09

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 84 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-14
• Study Completion Date: 2024-10-31

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.

Conditions

Postoperative Analgesia; Quality of Recovery; Supratentorial Tumor; Craniotomy; Scalp Nerve Block

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

control group

Patients in the control group will receive general anesthesia without the nerve blocks.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

scalp nerve block

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

Other Intervention Names

0.75% ropivacaine

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Second affiliated Hospital School of Medicine,Zhejiang University

Hangzhou, Zhejiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

Lina Yu, doctor

Role: CONTACT

zryulina@zju.edu.cn

+8613958033387

Facility Contacts

Lina Yu, doctor

Role: primary

zryulina@zju.edu.cn

+8613958033387

Other Identifiers

2023-0826

Identifier Type: -

Identifier Source: org_study_id