Prevention of Persistent Postsurgical Pain After Thoracotomy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by Hospital Clinic of Barcelona.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier:
NCT01243801
First received: November 15, 2010
Last updated: June 22, 2011
Last verified: June 2011
  Purpose

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.


Condition Intervention Phase
Persistent Pain
Postoperative Hyperalgesia
Drug: Ketamine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Phase 4 Study of Prevention of Persistent Postsurgical Pain After Thoracotomy Using Ketamine

Resource links provided by NLM:


Further study details as provided by Hospital Clinic of Barcelona:

Primary Outcome Measures:
  • Change from subjective pain scales: Visual Analogical Scale, Neuropathic Pain Symptoms Inventory, Catastrophism Scale [ Time Frame: -1day, 3 days, 7 days, 3 months, 6 months ] [ Designated as safety issue: No ]
    Pain measured with these subjective scales are assessed preoperatively (-1 day) and 3, 7 days, 3 and 6 months after surgery

  • Change from hyperalgesia periincisional area [ Time Frame: -1day, 3day,7day,3 months, 6 months ] [ Designated as safety issue: No ]
    Hyperalgesia is measured with von Frey monofilaments, electronic von frey and electric brush around the surgical incision and in a separate area (thigh)


Secondary Outcome Measures:
  • Adverse effects [ Time Frame: any time until 6 months ] [ Designated as safety issue: Yes ]
    Any adverse effects related to the use of ketamine (cognitive effects, visual effects, haemodynamic effects or sedation effects)


Estimated Enrollment: 90
Study Start Date: September 2008
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Epidural ketamine
  • Bolus of epidural ketamine during the induction of anesthesia
  • Epidural infusion of ketamine during the first 48 h after surgery

Postoperative analgesia: Epidural "Patient Controlled Analgesia" with ropivacaine and fentanyl

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
Active Comparator: Intravenous ketamine
  • Bolus of intravenous ketamine administered during the induction of anesthesia
  • Intravenous infusion during the first 48 hours after surgery

Postoperative analgesia: Epidural "Patient Controlled Analgesia" with ropivacaine plus fentanyl

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
Placebo Comparator: Placebo
Postoperative analgesia: Epidural "Patient Controlled Analgesia" with ropivacaine and fentanyl
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

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  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients over 18 years old submitted to thoracotomy or minithoracotomy expected to be extubated in the operating room

Exclusion Criteria:

  • Allergy or intolerance to ketamine, local anesthetics or opioids
  • Chronic preoperative pain
  • Chronic opioid treatment
  • Drug addiction
  • Polyneuropathy
  • Ischemic cardiopathy
  • Psychiatric disease
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01243801

Locations
Spain
Hospital Clinic Recruiting
Barcelona, Spain, 08036
Contact: Beatriz Tena    0034932275400 ext 5558    btena@clinic.ub.es   
Principal Investigator: Beatriz Tena, MD         
Department Anesthesia. Hospital Clinic Barcelona Recruiting
Barcelona, Spain, 08036
Contact: Beatriz Tena, MD    0034932275400 ext 5558    btena@clinic.ub.es   
Principal Investigator: Beatriz Tena, MD         
Sponsors and Collaborators
Hospital Clinic of Barcelona
Investigators
Principal Investigator: Beatriz Tena, MD Hospital Clinic of Barcelona
Study Director: Carmen Gomar, PhD Hospital Clinic of Barcelona
Study Chair: Irene Rovira, PhD Hospital Clinic of Barcelona
Study Chair: Maria J Jimenez, PhD Hospital Clinic of Barcelona
Study Chair: Guillermina Fita, PhD Hospital Clinic of Barcelona
Study Chair: Samuel Garcia, MD Hospital Clinic of Barcelona
Study Chair: Jordi Perez, PhD Hospital Clinic of Barcelona
Study Chair: Daniel Poggio, MD Hospital Clinic of Barcelona
Study Chair: Jose Rios Hospital Clinic of Barcelona
  More Information

Publications:
Responsible Party: Beatriz Tena, Anesthesiology Department. Hospital Clinic Barcelona
ClinicalTrials.gov Identifier: NCT01243801     History of Changes
Other Study ID Numbers: BTB-10
Study First Received: November 15, 2010
Last Updated: June 22, 2011
Health Authority: Spain: Ethics Committee

Keywords provided by Hospital Clinic of Barcelona:
chronic pain
persistent postsurgical pain
hyperalgesia
ketamine
quantitative sensory testing

Additional relevant MeSH terms:
Hyperalgesia
Somatosensory Disorders
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Ketamine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 21, 2014