A comparison between the continuous systemic administration of Lidocain and patient controlled intravenous morphine administration to control the pain after scoliosis surgery in adolescent with scloliosis.

A comparison between continuous systemic Lidocain and patient controlled intravenous morphine administration for pain control after posterior spinal fusion (PSF) in adolescent idiopatic scoliosis (AIS)

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-005264-98-BE

Enrollment

Unknown

Registered

2013-03-07

Start date

2013-05-06

Completion date

Unknown

Last updated

2017-08-21

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

Conditions

postoperative pain MedDRA version: 14.1 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 Current Sponsor code: Lidocaïne hydrochloride Other descriptive name: L

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: ASA I or II elective Posterior spinal fusion surgery Age (12-18 years) Are the trial subjects under 18? yes Number of subjects for this age range: 70 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Main Objective: Is the peri- and postoperative administration of lidocaine an effective traetment to reduce postoperative pain after scoliosis surgery of Adolescent idiopathic scoliosis.;Secondary Objective: Does the peri- and postoperative administration of lidocaine reduce: - the incidence of postoperative pain - the inflammatory respons - the use of co-analgesics - the incidence of PONV;Primary end point(s): Is the continuous systemic per-and postoperative administraion of lidocaine effective to treat pain after scoliosis surgery?;Timepoint(s) of evaluation of this end point: every 15 min. for the first 2 hours postoperatively	—

Measure

Time frame

Main Objective: Is the peri- and postoperative administration of lidocaine an effective traetment to reduce postoperative pain after scoliosis surgery of Adolescent idiopathic scoliosis.;Secondary Objective: Does the peri- and postoperative administration of lidocaine reduce: - the incidence of postoperative pain - the inflammatory respons - the use of co-analgesics - the incidence of PONV;Primary end point(s): Is the continuous systemic per-and postoperative administraion of lidocaine effective to treat pain after scoliosis surgery?;Timepoint(s) of evaluation of this end point: every 15 min. for the first 2 hours postoperatively

—

Secondary

Measure	Time frame
Secondary end point(s): incidence of PONV Less need of analgesics to reduce postoperative pain;Timepoint(s) of evaluation of this end point: every 15 min. for the first 2 hours postoperative	—

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