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

Phase 3

Completed

• Conditions: Partial Pneumonectomy Under Lateral or Posterolateral Thoracotomy.
• Interventions: Drug: Hypothetica

• Registration Number: NCT00313378
• Lead Sponsor: University Hospital, Clermont-Ferrand

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.

Study Timeline

• Study Start: 2004-04
• Study First Submitted: 2006-04-11
• Study First Submitted QC: 2006-04-11
• Study First Posted: 2006-04-12
• Primary Completion: 2008-05
• Study Completion: 2008-05
• Status Verified: 2013-04
• Last Update Submitted: 2013-04-02
• Last Update Posted: 2013-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 78

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ketamine	Hypothetica	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).
placebo	Hypothetica	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).

Primary Outcome Measures

Name	Time	Method
Reduction of chronic pain

Secondary Outcome Measures

Name	Time	Method
Reduction of signs of neuropathic pain.
Improvement of quality of life.

Trial Locations

Locations (1)

Clermont-Ferrand University Hospital; 🇫🇷 Clermont-Ferrand, Auvergne, France