Skip to main content
OpenTrials
Completed

NCT Number: NCT03648034

Effects of Scalp Nerve Block With Ropivacaine on Postoperative Recovery Quality

Patients undergoing elective meningeoma resection surgery will be randomly assigned to one of the following two groups. After anesthesia induction but before skull-pin insertion, one group will receive scalp nerve blocks with 0.5% ropivacaine, whereas the other group will receive scalp nerve blocks with 0.9% saline. The patients' postoperative recovery quality, which is evaluated by KPS score, peri-operative inflammatory responses, and post-operative pain degree will be evaluated and compared between the two groups.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Renji Hospital affliated to Shanghai Jiaotong University School of Medicine

Shanghai, 200127, China

About this study

Patients undergoing elective meningeoma resection surgery will be randomly assigned to one of the following two groups. After anesthesia induction but before skull-pin insertion, one group will receive scalp nerve blocks with 0.5% ropivacaine, whereas the other group will receive scalp nerve blocks with 0.9% saline. The patients' KPS scores at 3d after surgery and at discharge, serum levels of TNF-α、IL-6,IL-1β at 24h after surgery, satisfaction score after recovery, and VAS scores at 1, 2, 3 days post-surgery will be evaluated and compared between the two groups.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18-75 years old;
  • BMI 18-28 kg/m2;
  • ASA Physical Status 1-2;
  • Clinical diagnosis of primary Meningeoma and will have elective Meningeoma Resection Surgery;
  • With an estimated surgery time of less than 4h;
  • The incision will be conducted at the frontal, top or the temperal skull.

Exclusion criteria

  • A history of previous brain surgery;
  • Severe systemic disease (heart, lung, kidney, or immune system);
  • Nerval or mental disorders;
  • A history of addiction to opioids;
  • Allergic to ropivacaine;
  • Infection at block site or severe systemic infection;
  • Refuse to attend the trial.

Treatment and study plan

Ropivacaine

Procedure

To perform scalp nerve blocks with ropivacaine

Saline

Procedure

To perform scalp nerve blocks with saline

Primary outcomes

  1. KPS score

    Time frame: 7 days post-surgery

    Karnofsky performance score (KPS) allows patients to be classified as to their functional impairment. The total scale range is 0-100. The lower the KPS score, the worse the survival for most serious illnesses.

Secondary outcomes

  1. KPS score

    Time frame: 3 days post-surgery

    Karnofsky performance score (KPS) allows patients to be classified as to their functional impairment. The total scale range is 0-100. The lower the KPS score, the worse the survival for most serious illnesses.

  2. serum TNF-α levels

    Time frame: at 1h and 24h post-surgery

    an inflammatory mediator that reflects systemic inflammation

  3. serum IL-6 levels

    Time frame: at 1h and 24h post-surgery

    an inflammatory mediator that reflects systemic inflammation

  4. serum IL-1β levels

    Time frame: at 1h and 24h post-surgery

    an inflammatory mediator that reflects systemic inflammation

  5. Iowa Satisfaction with Anesthesia Scale (ISAS)

    Time frame: 1 hour after the surgery is finished

    Iowa Satisfaction with Anesthesia Scale (ISAS) comprises of 11 items to measure patient satisfaction after surgery. The total scale range is -33-+33. The higher the ISAS score, the better the satisfaction level.

  6. white blood cell

    Time frame: at 24 h after surgery

    serum white blood cell count

  7. serum levels of CRP

    Time frame: at 24 h after surgery

    inflammatory responses

  8. VAS score

    Time frame: at 1, 2 and 3 days post-surgery

    The visual analogue scale or visual analog scale (VAS) measures the average intensity of pain in the past on a 0-to-10 scale, where 0 = No pain and 10 = Pain as intense as you can imagine.

  9. pain-relief medications

    Time frame: at 1, 2 and 3 days post-surgery

    amounts of pain-relief medications

  10. Hospitalization Days

    Time frame: up to 30 days

    length of hospitalization

  11. out of pocket expenditure for hospitalisation

    Time frame: hospital discharge/up to 30 days

    This reflects how much money the patient spends during hospitalisation

  12. complications

    Time frame: within 30 days after surgery

    incidence of intracranial infection

Sponsors and collaborators

Lead sponsor

RenJi Hospital

Other

Registry information

Official study title

Effects of Preoperative Scalp Nerve Block on Postoperative Recovery Quality in Patients Undergoing Excision of Intracranial Meningioma

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Aug 27, 2018
Registry last updated
Apr 6, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.