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

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00313378
Enrollment
78
Registered
2006-04-12
Start date
2004-04-30
Completion date
2008-05-31
Last updated
2013-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Partial Pneumonectomy Under Lateral or Posterolateral Thoracotomy.

Keywords

Thoracotomy, Neuropathic pain, Nerve trauma, Ketamine, NMDA receptors

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.

Interventions

DRUGHypothetica

Sponsors

University Hospital, Clermont-Ferrand
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Reduction of chronic pain

Secondary

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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026