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

Zhejiang University

Status: Enrolling

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

Treatments: Procedure: scalp nerve block

Study type: Interventional

Funder types: Other

Identifiers

NCT06157359

2023-0826

Details and patient eligibility

About

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.

Enrollment: 84 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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84 participants in 2 patient groups

control group

No Intervention group

Description:

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

SNB group

Experimental group

Description:

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.

Treatment:

Procedure: scalp nerve block