Prevention of Persistent Postsurgical Pain After Thoracotomy

Summary

Postthoracotomy acute pain is followed by persistent postsurgical pain in 20-30% of the patients, defined as pain that lasts more than 3-6 months after surgery. Acute pain and hyperalgesia around the surgical wound are some of the risk factors associated to the development of chronic pain. Ketamine, as a NMDA antagonist mainly at spinal level, might reduce periincisional hyperalgesia and persistent postsurgical pain after thoracotomy. Therefore, the investigators hypothesized that continuous ketamine infusion at subanesthetic dose would potentiate epidural ropivacaine and fentanyl-induced analgesia after thoracotomy, reduce periincisional hyperalgesia and long-term postoperative pain. To test these hypothesis, the investigators administered a low dose of intravenous ketamine or epidural ketamine or placebo to patients who received an epidural infusion of ropivacaine and fentanyl for postthoracotomy pain.

Conditions

• Persistent Pain
• Postoperative Hyperalgesia

Interventions

DRUG

Ketamine

Intravenous ketamine 0.5mg/kg(induction of anesthesia)and 0.25 mg/kg/h for 48h Epidural Ketamine 0.5 mg/kg(induction of anesthesia)and 0.25 mg/kg/h for 48h

Sponsors & Collaborators

• Hospital Clinic of Barcelona

  lead OTHER

Principal Investigators

• Beatriz Tena, MD · Hospital Clinic of Barcelona

• Carmen Gomar, PhD · Hospital Clinic of Barcelona

• Irene Rovira, PhD · Hospital Clinic of Barcelona

• Maria J Jimenez, PhD · Hospital Clinic of Barcelona

• Guillermina Fita, PhD · Hospital Clinic of Barcelona

• Samuel Garcia, MD · Hospital Clinic of Barcelona

• Jordi Perez, PhD · Hospital Clinic of Barcelona

• Daniel Poggio, MD · Hospital Clinic of Barcelona

• Jose Rios · Hospital Clinic of Barcelona

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2008-09-30

Primary Completion

2011-10-31

Completion

2011-12-31

Countries

• Spain

Study Locations