Chronic Pain Clinical Trial
— GABATHOMIEOfficial title:
Perioperative Gabapentin for Chronic Post-thoracotomy Pain: a Randomized, Double Blind, Placebo-controlled Study.
Verified date | November 2022 |
Source | University Hospital, Lille |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
To assess the effects of prolonged preoperative gabapentin treatment (10 days) on chronic pain after thoracotomy.
Status | Completed |
Enrollment | 201 |
Est. completion date | May 24, 2019 |
Est. primary completion date | May 24, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
France | Department of Thoracic Surgery, Lille University Hospital | Lille |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Lille | University of Lille Nord de France |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Secondary | Quantitative pain assessment: Acute postoperative pain intensity | Measured on a 11-point numeric rating scale | Within the first 10 postoperative days | |
Secondary | Quantitative pain assessment: Rescue analgesics requirement | consumption of additional analgesics (opioids, nefopam or non steroidal anti-inflammatory drug) and time to first request. | Within the first 3 months after surgery | |
Secondary | Quantitative pain assessment: volume of epidural infusion | total dose of epidural local anesthetic and epidural morphine | Within the 5 postoperative days | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | Heath related quality of life | measured by EQ-5D-5L questionnaire | 3 months after surgery | |
Secondary | Assessment of sedation in the operating room | measured by MOAA/S scale ( Modified Observer's Assessment of alternes/sedation Scale) | baseline |
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