Prevention of Persistent Postsurgical Pain After Thoracotomy

NCT01243801 | Completed Phase 4

• 1 other identifier: BTB-10
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

chronic pain; persistent postsurgical pain; hyperalgesia; ketamine; quantitative sensory testing

Outcome Measures

Primary Outcomes (2)

• Change from subjective pain scales: Visual Analogical Scale, Neuropathic Pain Symptoms Inventory, Catastrophism Scale

  Pain measured with these subjective scales are assessed preoperatively (-1 day) and 3, 7 days, 3 and 6 months after surgery

  -1day, 3 days, 7 days, 3 months, 6 months

• Change from hyperalgesia periincisional area

  Hyperalgesia is measured with von Frey monofilaments, electronic von frey and electric brush around the surgical incision and in a separate area (thigh)

  -1day, 3day,7day,3 months, 6 months

Secondary Outcomes (1)

• Adverse effects

  any time until 6 months

Study Arms (3)

Epidural ketamine

ACTIVE COMPARATOR

* 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

ACTIVE COMPARATOR

* 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

Placebo

PLACEBO COMPARATOR

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

Drug: Ketamine

Interventions

Ketamine DRUG

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

Epidural ketamine; Intravenous ketamine; Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Allergy or intolerance to ketamine, local anesthetics or opioids
• Chronic preoperative pain
• Chronic opioid treatment
• Drug addiction
• Polyneuropathy
• Ischemic cardiopathy
• Psychiatric disease

Sponsors & Collaborators

• Hospital Clinic of Barcelona: lead

Study Sites (2)

Department Anesthesia. Hospital Clinic Barcelona

Barcelona, Barcelona, 08036, Spain

Location

Hospital Clinic

Barcelona, Barcelona, 08036, Spain

Location

Related Publications (2)

• 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. doi: 10.1016/j.bpa.2006.12.006.

  PMID: 17489221 BACKGROUND

• 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. doi: 10.1097/00000542-200607000-00020.

  PMID: 16810002 BACKGROUND

MeSH Terms

Conditions

Chronic Pain; Pain, Postoperative; Hyperalgesia

Interventions

Ketamine

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Somatosensory Disorders; Sensation Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Beatriz Tena, MD

  Hospital Clinic of Barcelona

  PRINCIPAL INVESTIGATOR

• Carmen Gomar, PhD

  Hospital Clinic of Barcelona

  STUDY DIRECTOR

• 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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr Tena

Study Record Dates

• First Submitted: November 15, 2010
• First Posted: November 19, 2010
• Study Start: September 1, 2008
• Primary Completion: October 1, 2011
• Study Completion: December 1, 2011
• Last Updated: March 23, 2015

Record last verified: 2015-03

Locations

ES (2)