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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-005226-35 | EudraCT Number |
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| Name | Class |
|---|---|
| University of Lille Nord de France | OTHER |
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To assess the effects of prolonged preoperative gabapentin treatment (10 days) on chronic pain after thoracotomy.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| gabapentin group | Experimental |
|
|
| placebo group | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gabapentin | Drug |
|
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Persistent chronic post-thoracotomy pain | Pain intensity is measured on a 11-point numeric pain rating scale ; a score >=0 is considered as chronic pain. | 3 months after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Quantitative pain assessment: Acute postoperative pain intensity | Measured on a 11-point numeric rating scale | Within the first 10 postoperative days |
| Quantitative pain assessment: Rescue analgesics requirement |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jacques Desbordes, MD | University Hospital, Lille | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Thoracic Surgery, Lille University Hospital | Lille | 59000 | France |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D059350 | Chronic Pain |
| D009437 | Neuralgia |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D000077206 | Gabapentin |
| D007785 | Lactose |
| ID | Term |
|---|---|
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
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| Drug |
|
|
consumption of additional analgesics (opioids, nefopam or non steroidal anti-inflammatory drug) and time to first request.
| Within the first 3 months after surgery |
| Quantitative pain assessment: volume of epidural infusion | total dose of epidural local anesthetic and epidural morphine | Within the 5 postoperative days |
| Qualitative pain assessment: incidence of neuropathic pain | Assessed by DN4 (Neuropathic pain 4), NPSI (Neuropathic Pain Symptom Inventory) and QDSA ( Saint Antoine French questionnaire = McGill questionnaire) | postoperative day 2 |
| Qualitative pain assessment: incidence of neuropathic pain | Assessed by DN4 (Neuropathic pain 4), NPSI (Neuropathic Pain Symptom Inventory) and QDSA ( Saint Antoine French questionnaire = McGill questionnaire) | postoperative day 6 |
| Qualitative pain assessment: incidence of neuropathic pain | Assessed by DN4 (Neuropathic pain 4), NPSI (Neuropathic Pain Symptom Inventory) and QDSA ( Saint Antoine French questionnaire = McGill questionnaire) | 3 months after surgery |
| Qualitative pain assessment: Rescue analgesics requirement for neuropathic pain | Time to first request and consumption (doses and length of treatment) of gapapentinoids, amitriptyline | within the first 3 months after surgery |
| Qualitative pain assessment: Objective assessment of hyperalgesia by the Von Frey filaments test | 60 and 300 g Von Frey filaments test on the thoracotomy area | 3 months after surgery |
| Heath related quality of life | measured by EQ-5D-5L questionnaire | 3 months after surgery |
| Assessment of sedation in the operating room | measured by MOAA/S scale ( Modified Observer's Assessment of alternes/sedation Scale) | baseline |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D002087 |
| Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D004187 | Disaccharides |
| D009844 | Oligosaccharides |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
| D000073893 | Sugars |