A study that examines the postoperative pain and Morphine use of patients who received systemic Lidocain administration during oncological gynaecological surgery.

Systemic administration of Lidocain for oncological gynaecological surgery: the effect on postoperative pain and consumption of Morphine

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-003255-38-BE

Enrollment

Registered

2013-08-20

Start date

2013-10-08

Completion date

Unknown

Last updated

2018-06-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

postoperative pain MedDRA version: 16.0 Level: LLT Classification code 10036236 Term: Postoperative pain relief System Organ Class: 100000004865

Interventions

Trade Name: Linisol 1% Product Name: linisol 1% Pharmaceutical Form: Injection INN or Proposed INN: linisol CAS Number: 137-58-6 Other descriptive name: LIDOCAINE 1% Concentration unit: % percent Conc

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • ASA 1,2 en 3 • Elective gynaecological oncological surgery for ovarium carcinoma • age = 18 year of age Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 30 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30

Exclusion criteria

Exclusion criteria: Allergy to Lidocaine chronic use of opioids Liver and renal insuffiency epilepsy cardiac dysrhythmia mental retardation

Design outcomes

Primary

Measure	Time frame
Main Objective: Does the peri-operative systemic administration of Lidocain reduce the postoperative consumption of Opioids;Secondary Objective: Does the peri-and postoperative administration of Lidocaine reduce: - The inflammatory respons - The incidence of PONV - the developement of persisting pain - the length of hospitalisation - the tumor recidive and metastases.;Primary end point(s): Is the systemic peri-and postoperative administration of Lidocaine effective to treat postoperative pain after oncological gynaecological surgery?;Timepoint(s) of evaluation of this end point: every 15 minutes for the first 2 hours postoperatively; the following 22 hours: every hour	—

Measure

Time frame

Main Objective: Does the peri-operative systemic administration of Lidocain reduce the postoperative consumption of Opioids;Secondary Objective: Does the peri-and postoperative administration of Lidocaine reduce: - The inflammatory respons - The incidence of PONV - the developement of persisting pain - the length of hospitalisation - the tumor recidive and metastases.;Primary end point(s): Is the systemic peri-and postoperative administration of Lidocaine effective to treat postoperative pain after oncological gynaecological surgery?;Timepoint(s) of evaluation of this end point: every 15 minutes for the first 2 hours postoperatively; the following 22 hours: every hour

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Secondary

Measure	Time frame
Secondary end point(s): Does the peri-and postoperative administration of Lidocaine reduce: - The inflammatory respons - The incidence of PONV - The developement of persisting pain - The length of hospitalisation - The tumor recidive and metastases. - The incidence of PONV ;Timepoint(s) of evaluation of this end point: every 15 minutes for the first 2 hours postoperative The following 22 hours: every hour once daily on postoperative day 2 and 3 3 and 6 month postoperative (telephone call)	—

Measure

Time frame

Secondary end point(s): Does the peri-and postoperative administration of Lidocaine reduce: - The inflammatory respons - The incidence of PONV - The developement of persisting pain - The length of hospitalisation - The tumor recidive and metastases. - The incidence of PONV ;Timepoint(s) of evaluation of this end point: every 15 minutes for the first 2 hours postoperative The following 22 hours: every hour once daily on postoperative day 2 and 3 3 and 6 month postoperative (telephone call)

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Countries

Belgium

Contacts

Public ContactAnesthesia research

University hospitals Leuven

christel.huygens@uzleuven.be3216344620

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026