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

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 \[6\].

Intervention / Treatment

  • Hypothetica (DRUG)
    N/A

Condition or Disease

  • Partial Pneumonectomy Under Lateral or Posterolateral Thoracotomy.

Phase

  • Phase 3
  • Study Design

    Study type: INTERVENTIONAL
    Status: Completed
    Study results: No Results Available
    Age: 20 Years to 75 Years
    Enrollment: 78 (ACTUAL)
    Funded by: Other
    Allocation: Randomized
    Primary Purpose: Treatment

    Masking

    DOUBLE:
    • Participant
    • Investigator

    Clinical Trial Dates

    Start date: Apr 01, 2004
    Primary Completion: May 01, 2008 ACTUAL
    Completion Date: May 01, 2008 ACTUAL
    Study First Posted: Apr 12, 2006 ESTIMATED
    Results First Posted: Aug 31, 2020
    Last Updated: Apr 02, 2013

    Sponsors / Collaborators

    Lead sponsor is responsible party
    Responsible Party: N/A

    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.

    Participant Groups

    • 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).

    Eligibility Criteria

    Sex: All
    Minimum Age: 20
    Maximum Age: 75
    Age Groups: Adult / Older Adult
    Healthy Volunteers: Yes

    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

    Primary Outcomes
    • Reduction of chronic pain
    Secondary Outcomes
    • Reduction of signs of neuropathic pain.
    • Improvement of quality of life.

    More Details

    NCT Number: NCT00313378
    Other IDs: CHU63-0004
    Study URL: https://clinicaltrials.gov/study/NCT00313378
    Last updated: Sep 29, 2023