search
Back to results

Effects of Perioperative Systemic Ketamine on Development of Long-term Neuropathic Pain After Thoracotomy

Primary Purpose

Partial Pneumonectomy Under Lateral or Posterolateral Thoracotomy.

Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Hypothetica
Sponsored by
University Hospital, Clermont-Ferrand
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Partial Pneumonectomy Under Lateral or Posterolateral Thoracotomy. focused on measuring Thoracotomy, Neuropathic pain, Nerve trauma, Ketamine, NMDA receptors

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: elective partial pneumonectomy under lateral or posterolateral thoracotomy, performed under standardized general anesthesia. Exclusion Criteria: Patient's refusal Bad health status Previous neuropathic pain or treatment acting on neuropathic pain Major postoperative complication Intolerance to ketamine Epidural anesthesia

Sites / Locations

  • Clermont-Ferrand University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

ketamine

placebo

Arm Description

This study compares two groups of patients undergoing thoracotomy for partial pneumonectomy, one receiving intravenous ketamine since the beginning of procedure and then during 48 hours, the other receiving inactive normal saline (placebo).

This study compares two groups of patients undergoing thoracotomy for partial pneumonectomy, one receiving intravenous ketamine since the beginning of procedure and then during 48 hours, the other receiving inactive normal saline (placebo).

Outcomes

Primary Outcome Measures

Reduction of chronic pain

Secondary Outcome Measures

Reduction of signs of neuropathic pain.
Improvement of quality of life.

Full Information

First Posted
April 11, 2006
Last Updated
April 2, 2013
Sponsor
University Hospital, Clermont-Ferrand
search

1. Study Identification

Unique Protocol Identification Number
NCT00313378
Brief Title
Effects of Perioperative Systemic Ketamine on Development of Long-term Neuropathic Pain After Thoracotomy
Official Title
Effects of Perioperative Systemic Ketamine on Development of Long-term Neuropathic Pain After Thoracotomy.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
April 2004 (undefined)
Primary Completion Date
May 2008 (Actual)
Study Completion Date
May 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Clermont-Ferrand

4. Oversight

5. Study Description

Brief Summary
Lung surgery under thoracotomy is known to induce long-term pain which can be considered as neuropathic in many patients concerned [1,2]. The suspected origin of neuropathy is a direct traumatism of intercostal nerve(s) [3]. Among the possible preventive treatments that can be administered during the initial aggression, ketamine [4,5] appears as the easiest to use, as it is already commonly administered intra and postoperatively for improvement of analgesia [6].
Detailed Description
Lung surgery under thoracotomy is known to induce long-term pain which can be considered as neuropathic in many patients concerned [1,2]. The suspected origin of neuropathy is a direct traumatism of intercostal nerve(s) [3]. Among the possible preventive treatments that can be administered during the initial aggression, ketamine [4,5] appears as the easiest to use, as it is already commonly administered intra and postoperatively for improvement of analgesia [6]. This study compares two groups of patients undergoing thoracotomy for partial pneumonectomy, one receiving intravenous ketamine since the beginning of procedure and then during 48 hours, the other receiving inactive normal saline (placebo). The study is prospective, randomized, and double-blinded. The primary endpoint is to reduce chronic pain (on visual analogue scale) at the 4th month after surgery with ketamine. The objective is to obtain a mean value under 20/100 in the ketamine group, considering that the expected mean value for the control group is 38/100 (based on personal observations). The secondary endpoints are lower scores of neuropathic pain in the ketamine group, assessed by the NPSI questionnaire [7]. The impact of treatment on quality of life, assessed by a questionnaire (SF-36), is also studied. The data collected by clinical and psychophysical examination performed on all patients at the 4th month after surgery will be also considered for analysis, in order to understand better the features of post-thoracotomy neuropathic pain.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Partial Pneumonectomy Under Lateral or Posterolateral Thoracotomy.
Keywords
Thoracotomy, Neuropathic pain, Nerve trauma, Ketamine, NMDA receptors

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
78 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ketamine
Arm Type
Experimental
Arm Description
This study compares two groups of patients undergoing thoracotomy for partial pneumonectomy, one receiving intravenous ketamine since the beginning of procedure and then during 48 hours, the other receiving inactive normal saline (placebo).
Arm Title
placebo
Arm Type
Other
Arm Description
This study compares two groups of patients undergoing thoracotomy for partial pneumonectomy, one receiving intravenous ketamine since the beginning of procedure and then during 48 hours, the other receiving inactive normal saline (placebo).
Intervention Type
Drug
Intervention Name(s)
Hypothetica
Primary Outcome Measure Information:
Title
Reduction of chronic pain
Secondary Outcome Measure Information:
Title
Reduction of signs of neuropathic pain.
Title
Improvement of quality of life.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: elective partial pneumonectomy under lateral or posterolateral thoracotomy, performed under standardized general anesthesia. Exclusion Criteria: Patient's refusal Bad health status Previous neuropathic pain or treatment acting on neuropathic pain Major postoperative complication Intolerance to ketamine Epidural anesthesia
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christian Duale, Doctor
Organizational Affiliation
University Hospital, Clermont-Ferrand
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clermont-Ferrand University Hospital
City
Clermont-Ferrand
State/Province
Auvergne
ZIP/Postal Code
63000
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
10342006
Citation
Perttunen K, Tasmuth T, Kalso E. Chronic pain after thoracic surgery: a follow-up study. Acta Anaesthesiol Scand. 1999 May;43(5):563-7. doi: 10.1034/j.1399-6576.1999.430513.x.
Results Reference
background
PubMed Identifier
11394926
Citation
Gotoda Y, Kambara N, Sakai T, Kishi Y, Kodama K, Koyama T. The morbidity, time course and predictive factors for persistent post-thoracotomy pain. Eur J Pain. 2001;5(1):89-96. doi: 10.1053/eujp.2001.0225.
Results Reference
background
PubMed Identifier
11825739
Citation
Rogers ML, Henderson L, Mahajan RP, Duffy JP. Preliminary findings in the neurophysiological assessment of intercostal nerve injury during thoracotomy. Eur J Cardiothorac Surg. 2002 Feb;21(2):298-301. doi: 10.1016/s1010-7940(01)01104-6.
Results Reference
background
PubMed Identifier
8740606
Citation
Felsby S, Nielsen J, Arendt-Nielsen L, Jensen TS. NMDA receptor blockade in chronic neuropathic pain: a comparison of ketamine and magnesium chloride. Pain. 1996 Feb;64(2):283-291. doi: 10.1016/0304-3959(95)00113-1.
Results Reference
background
PubMed Identifier
10338169
Citation
Burton AW, Lee DH, Saab C, Chung JM. Preemptive intrathecal ketamine injection produces a long-lasting decrease in neuropathic pain behaviors in a rat model. Reg Anesth Pain Med. 1999 May-Jun;24(3):208-13. doi: 10.1016/s1098-7339(99)90129-3.
Results Reference
background
PubMed Identifier
11376910
Citation
De Kock M, Lavand'homme P, Waterloos H. 'Balanced analgesia' in the perioperative period: is there a place for ketamine? Pain. 2001 Jun;92(3):373-380. doi: 10.1016/S0304-3959(01)00278-0.
Results Reference
background
PubMed Identifier
15030944
Citation
Bouhassira D, Attal N, Fermanian J, Alchaar H, Gautron M, Masquelier E, Rostaing S, Lanteri-Minet M, Collin E, Grisart J, Boureau F. Development and validation of the Neuropathic Pain Symptom Inventory. Pain. 2004 Apr;108(3):248-257. doi: 10.1016/j.pain.2003.12.024.
Results Reference
background
PubMed Identifier
18783971
Citation
Duale C, Sibaud F, Guastella V, Vallet L, Gimbert YA, Taheri H, Filaire M, Schoeffler P, Dubray C. Perioperative ketamine does not prevent chronic pain after thoracotomy. Eur J Pain. 2009 May;13(5):497-505. doi: 10.1016/j.ejpain.2008.06.013. Epub 2008 Sep 9.
Results Reference
result
Links:
URL
http://www.ncbi.nlm.nih.gov/pubmed/18783971
Description
Related Info

Learn more about this trial

Effects of Perioperative Systemic Ketamine on Development of Long-term Neuropathic Pain After Thoracotomy

We'll reach out to this number within 24 hrs