Prevention of Persistent Postsurgical Pain After Thoracotomy - Full Text View

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:

MedlinePlus related topics: Chronic Pain

Drug Information available for: Ketamine hydrochloride Ketamine

U.S. FDA Resources

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

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 Barcelona
Study Director:	Carmen Gomar, PhD	Hospital Clinic Barcelona
Study Chair:	Irene Rovira, PhD	Hospital Clinic Barcelona
Study Chair:	Maria J Jimenez, PhD	Hospital Clinic Barcelona
Study Chair:	Guillermina Fita, PhD	Hospital Clinic Barcelona
Study Chair:	Samuel Garcia, MD	Hospital Clinic Barcelona
Study Chair:	Jordi Perez, PhD	Hospital Clinic Barcelona
Study Chair:	Daniel Poggio, MD	Hospital Clinic Barcelona
Study Chair:	Jose Rios	Hospital Clinic Barcelona

More Information

Publications:

De Kock MF, Lavand'homme PM. The clinical role of NMDA receptor antagonists for the treatment of postoperative pain. Best Pract Res Clin Anaesthesiol. 2007 Mar;21(1):85-98. Review.

Suzuki M, Haraguti S, Sugimoto K, Kikutani T, Shimada Y, Sakamoto A. Low-dose intravenous ketamine potentiates epidural analgesia after thoracotomy. Anesthesiology. 2006 Jul;105(1):111-9.

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
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants

Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Analgesics
Sensory System Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on May 21, 2013