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

NCT06157359 | Unknown

• 1 other identifier: 2023-0826
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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

Keywords

Supratentorial tumor resection; Scalp nerve block; quality of recovery; postoperative analgesia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• the 15-item QoR score at 72 hours after surgery

  up to day3 after surgery

• postoperative pain scores

  up to day3 after surgery

• Riker Sedation-Agitation Scale

  during in PACU, an average of 3 hours

• nausea and vomiting

  up to day3 after surgery

• opioids and propofol consumption

  during operation and in PACU, an average of 8 hours

Study Arms (2)

control group

NO INTERVENTION

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

SNB group

EXPERIMENTAL

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

Interventions

scalp nerve block 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.

Also known as: 0.75% ropivacaine

SNB group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Second affiliated Hospital School of Medicine,Zhejiang University

Hangzhou, Zhejiang, China

RECRUITING

MeSH Terms

Conditions

Supratentorial Neoplasms

Interventions

Ropivacaine

Condition Hierarchy (Ancestors)

Brain Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Central Study Contacts

Lina Yu, doctor

CONTACT

+8613958033387; zryulina@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2023
• First Posted: December 5, 2023
• Study Start: November 14, 2023
• Primary Completion: October 31, 2024
• Study Completion: October 31, 2024
• Last Updated: August 9, 2024

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)