Local Infiltration Analgesia in Major Spine Surgery With Ropivacaine Versus Placebo

Hvidovre University Hospital

Status and phase: Completed; Phase 4

Conditions: Pain, Postoperative

Treatments: Drug: Ropivacaine 0.5 %; Drug: Isotonic NaCl

Study type: Interventional

Funder types: Other

Identifiers

NCT00771459

H-D-2007-0111

Details and patient eligibility

About

The purpose of this study is to examine whether local infiltration analgesia (LIA) with Ropivacaine and adrenaline is effective in the treatment of postoperative pain after major spine surgery.

Enrollment: 48 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients eligible for major spine surgery
• must speak and understand Danish
• must be able to give oral and written consent

Exclusion criteria

• alcohol or medicine abuse
• treatment with opioids > 100 mg daily
• allergy to local anesthetics
• severe obesity

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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48 participants in 2 patient groups, including a placebo group

Ropivacaine

Active Comparator group

Treatment:

Drug: Ropivacaine 0.5 %

Placebo

Placebo Comparator group

Treatment:

Drug: Isotonic NaCl