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

NCT ID: NCT00313378

Last Updated: 2013-04-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 78 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-04-30
• Study Completion Date: 2008-05-31

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.

Conditions

Partial Pneumonectomy Under Lateral or Posterolateral Thoracotomy.

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

ketamine

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).

Group Type: EXPERIMENTAL

Hypothetica

Intervention Type: DRUG

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).

Group Type: OTHER

Hypothetica

Intervention Type: DRUG

Interventions

Hypothetica

Intervention Type: DRUG

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Clermont-Ferrand

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christian Duale, Doctor

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Clermont-Ferrand

Locations

Clermont-Ferrand University Hospital

Clermont-Ferrand, Auvergne, France

Countries

France

References

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.

Reference Type: BACKGROUND

PMID: 10342006 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 11394926 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 11825739 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 8740606 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 10338169 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 11376910 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 15030944 (View on PubMed)

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.

Reference Type: RESULT

PMID: 18783971 (View on PubMed)

Related Links

http://www.ncbi.nlm.nih.gov/pubmed/18783971

Related Info

Other Identifiers

CHU63-0004

Identifier Type: -

Identifier Source: org_study_id