Effects of Scalp Nerve Block With Ropivacaine on Postoperative Recovery Quality

NCT03648034 | Completed

• 1 other identifier: SNB20180813
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Meningioma

Outcome Measures

Primary Outcomes (1)

• KPS score

  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.

  7 days post-surgery

Secondary Outcomes (12)

• KPS score

  3 days post-surgery

• serum TNF-α levels

  at 1h and 24h post-surgery

• serum IL-6 levels

  at 1h and 24h post-surgery

• serum IL-1β levels

  at 1h and 24h post-surgery

• Iowa Satisfaction with Anesthesia Scale (ISAS)

  1 hour after the surgery is finished

Study Arms (2)

ropivacaine

EXPERIMENTAL

After anesthesia induction but before skull-pin insertion, patients in this group will receive scalp nerve blocks with 0.5% ropivacaine

Procedure: ropivacaine

saline

PLACEBO COMPARATOR

After anesthesia induction but before skull-pin insertion, patients in this group will receive scalp nerve blocks with 0.9% saline

Procedure: saline

Interventions

ropivacaine PROCEDURE

To perform scalp nerve blocks with ropivacaine

ropivacaine

saline PROCEDURE

To perform scalp nerve blocks with saline

saline

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• RenJi Hospital: lead

Study Sites (1)

Renji Hospital affliated to Shanghai Jiaotong University School of Medicine

Shanghai, 200127, China

Location

MeSH Terms

Conditions

Meningioma

Interventions

Ropivacaine; Sodium Chloride

Condition Hierarchy (Ancestors)

Neoplasms, Nerve Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Vascular Tissue; Meningeal Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 13, 2018
• First Posted: August 27, 2018
• Study Start: September 18, 2018
• Primary Completion: September 30, 2019
• Study Completion: November 30, 2019
• Last Updated: April 6, 2020

Record last verified: 2020-04

Locations

CN (1)