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

Last updated: August 7, 2024
Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Brain Cancer

Brain Tumor

Treatment

scalp nerve block

Clinical Study ID

NCT06157359
2023-0826
  • Ages 18-65
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

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 systemdisease ;

  • 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, orlocated 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 cognitiveimpairment, a history of mental illness, unable to communicate and complete thescale assessment;

  • patients with severe hemodynamic disturbances or other life-threateningcomplications during the operation, or those transferred to the intensive care unit (ICU) after surgery.

Study Design

Total Participants: 84
Treatment Group(s): 1
Primary Treatment: scalp nerve block
Phase:
Study Start date:
November 14, 2023
Estimated Completion Date:
October 31, 2024

Connect with a study center

  • Second affiliated Hospital School of Medicine,Zhejiang University

    Hangzhou, Zhejiang
    China

    Active - Recruiting

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