Perioperative Pregabalin and Continuous Wound Infusion for Pain Control Following Thoracotomy

Attikon University Hospital

Status and phase: Completed; Phase 4

Conditions: Post-thoracotomy Pain

Treatments: Drug: Pregabalin and ropivacaine 02% infusion; Drug: Placebo drug, normal saline infusion; Drug: Pregabalin and normal saline infusion, PRG

Study type: Interventional

Funder types: Other

Identifiers

NCT01726205

PRGCWI1

Details and patient eligibility

About

The purpose of this study is to assess the efficacy of pregabalin or pregabalin and continuous wound infusion versus placebo for analgesia following thoracotomy

Enrollment: 45 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients scheduled for a thoracotomy,

Exclusion criteria

• age >70 years
• BMI > 30
• preoperative Hb < 10 mg/dL
• preexistent chronic pain
• neurologic disease
• chronic assumption of alcohol
• treatment with analgesics, anxiolytics, sedatives, antidepressants, or calcium channel inhibitors

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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45 participants in 3 patient groups, including a placebo group

pregabalin

Active Comparator group

Description:

perioperative pregabalin starting the evening before surgery, and for five days postoperatively

Treatment:

Drug: Pregabalin and normal saline infusion, PRG

pregabalin and continuous wound infusion

Active Comparator group

Description:

Pregabalin as previous group and continuous infusion of ropivacaine 0.2% via a wound catheter

Treatment:

Drug: Pregabalin and ropivacaine 02% infusion

placebo

Placebo Comparator group

Description:

Placebo drug and normal saline infusion

Treatment:

Drug: Placebo drug, normal saline infusion