Chronic Pain, Postoperative Pain
Conditions
Keywords
gabapentin, thoracotomy, chronic post-thoracotomy pain, acute post-thoracotomy pain, quality of life, neuropathic pain
Brief summary
To assess the effects of prolonged preoperative gabapentin treatment (10 days) on chronic pain after thoracotomy.
Detailed description
Randomized, double blind study enrolling 200 adults undergoing thoracotomy. Patients receive either 75 mg hydroxyzine before surgery and placebo 3 times daily for 10 days or 1200 mg gabapentin before surgery continued for 10 days. All patients receive also a thoracic epidural analgesia. Assessment of chronic pain at 3 month with an evaluation by a physician (pain intensity, pain quality and analgesia requirement). Assessment of acute pain in the early postoperative period (pain intensity, pain quality and analgesia requirement).
Interventions
DRUGGabapentin
DRUGPlacebo
Sponsors
University of Lille Nord de France
University Hospital, Lille
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* age \> 18 years * elective lung resection via thoracotomy
Exclusion criteria
* extended pleurectomy and chest wall resection * previous ipsilateral thoracotomy * previous ipsilateral radiotherapy * thoracotomy for pyothorax * chest injury * palliative surgery * contraindicated placement of a thoracic epidural catheter * allergy to medications on protocol * pre-existing pain syndrome * current treatment with morphine, gabapentin, pregabalin, anticonvulsivants or tricyclic antidepressants * a history of past or current drug addiction * severe hepatic, renal or cardiovascular disorders * inability to understand the study protocol or to answer the questionnaires on pain and quality of life * severe psychiatric disorders * incompetent adults under some form of guardianship * refusal of the protocol * persons without social security coverage * pregnant or lactating woman
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Persistent chronic post-thoracotomy pain | 3 months after surgery | Pain intensity is measured on a 11-point numeric pain rating scale ; a score \>=0 is considered as chronic pain. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quantitative pain assessment: Rescue analgesics requirement | Within the first 3 months after surgery | consumption of additional analgesics (opioids, nefopam or non steroidal anti-inflammatory drug) and time to first request. |
| Quantitative pain assessment: volume of epidural infusion | Within the 5 postoperative days | total dose of epidural local anesthetic and epidural morphine |
| Qualitative pain assessment: incidence of neuropathic pain | postoperative day 2 | Assessed by DN4 (Neuropathic pain 4), NPSI (Neuropathic Pain Symptom Inventory) and QDSA ( Saint Antoine French questionnaire = McGill questionnaire) |
| Quantitative pain assessment: Acute postoperative pain intensity | Within the first 10 postoperative days | Measured on a 11-point numeric rating scale |
| Qualitative pain assessment: Objective assessment of hyperalgesia by the Von Frey filaments test | 3 months after surgery | 60 and 300 g Von Frey filaments test on the thoracotomy area |
| Heath related quality of life | 3 months after surgery | measured by EQ-5D-5L questionnaire |
| Assessment of sedation in the operating room | baseline | measured by MOAA/S scale ( Modified Observer's Assessment of alternes/sedation Scale) |
| Qualitative pain assessment: Rescue analgesics requirement for neuropathic pain | within the first 3 months after surgery | Time to first request and consumption (doses and length of treatment) of gapapentinoids, amitriptyline |
Countries
France
Outcome results
None listed