Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06157359
Other study ID # 2023-0826
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date November 27, 2023
Est. completion date October 31, 2024

Study information

Verified date November 2023
Source Second Affiliated Hospital, School of Medicine, Zhejiang University
Contact Lina Yu, doctor
Phone +8613958033387
Email zryulina@zju.edu.cn
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 84
Est. completion date October 31, 2024
Est. primary completion date October 31, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design


Intervention

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.

Locations

Country Name City State
China Second affiliated Hospital School of Medicine,Zhejiang University Hangzhou Zhejiang

Sponsors (1)

Lead Sponsor Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary adverse events Adverse events within 72 hours after operation are recorded. up to day3 after surgery
Secondary total medical expenses The total medical expenses is recorded during hospitalization. during hospitalization, an average of 10 days
See also
  Status Clinical Trial Phase
Completed NCT05023850 - Comparing Thoracolumbar Interfascial Plane Block With Erector Spinae Plane Block N/A
Completed NCT06205199 - Analgesic Effect of Ropivacaine Combined With Hydromorphone for CSEA After Total Knee Arthroplasty N/A
Not yet recruiting NCT06062550 - Different Dose Esketamine and Dexmedetomidine Combination for Supplemental Analgesia After Scoliosis Correction Surgery Phase 4
Completed NCT03239314 - Analgesic Effect of Adductor Canal Block With and Without Dexamethasone for Knee Arthroscopy N/A
Completed NCT05317572 - Comparison of Three Different Doses of Intrathecal Morphine for Analgesia After Cesarean Section N/A
Completed NCT03258255 - Analgesic Efficiency of Pudendal Nerve Block Versus Penil Block for Circumsion in Children N/A
Recruiting NCT06078241 - Postoperative Analgesia in Patients Undergoing Percutaneous Nephrolithotomy N/A
Recruiting NCT06430112 - Liposomal Bupivacaine vs Ropivacaine for TAPBs Phase 3
Completed NCT04579302 - Serratus Anterior Block and Erector Spinae Block in Postoperative Analgesia N/A
Completed NCT04111848 - Magnesium and Ketamine in Postoperative Analgesia Phase 4
Completed NCT03341234 - Superficial Serratus Plane Block for Modified Radical Mastectomy and Axillary Lymph Node Disection N/A
Recruiting NCT03540537 - A Trial Comparing Quadratus Lumborum Block (QLB) and Paravertebral Block (PVTB) for Postoperative Analgesia in Hepatectomy N/A
Terminated NCT02150161 - Opioid vs. Opioid-free Anesthesia for Hip Arthroscopy Phase 3
Not yet recruiting NCT01589354 - Effectiveness of Interscalene Brachial Plexus Block and Intra-articular Injection of Ropivacaine for Post-operative Analgesia in Arthroscopic Shoulder Stabilization Surgery N/A
Completed NCT05855798 - Ketamine and Magnesium in Erector Spinae Plane Block Phase 4
Not yet recruiting NCT04845711 - Ultrasound Guided Erector Spinae Plane Block Versus Quadratus Lumborum Block in Laparoscopic Cholecystectomy N/A
Completed NCT03131375 - Dexmedetomidine Reduces Emergence Delirium in Children Undergoing Tonsillectomy With Propofol Anesthesia Phase 2/Phase 3
Completed NCT03885427 - Analgo-Sedative Effects Of Oral, Or Nebulized Ketamine In Pre-schoolers Undergoing Elective Surgery. Early Phase 1
Completed NCT04738357 - A Clinical Study to Evaluate Efficacy and Safety of HSK21542 for Postoperative Analgesia of Subjects Undergoing Elective Laparoscopic Surgery Under General Anesthesia Phase 3
Active, not recruiting NCT03673280 - Quadratus Lumborum in Cesarean Section Trial N/A