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Clinical trial

Gabapentin for the Reduction of Opiate Use Following Pulmonary Resection (GROUP Trial)

ID
Name
2021-0653
Description
The aim of this study is to determine if the reduction in narcotic requirement following pulmonary resection with gabapentin is clinically significant when compared to the effect seen with placebo. We have defined clinically meaningful as a reduction by 30 Morphine equivalent doses (MED)
Trial arms
Trial start
2021-09-15
Estimated PCD
2023-01-03
Trial end
2023-01-03
Status
Withdrawn
Phase
Early phase I
Treatment
Gabapentin
Given by PO
Arms:
Gabapentin
Placebo
Given by PO
Arms:
Placebo
Primary endpoint
The change in narcotic requirement following pulmonary resection with gabapentin is clinically significant when compared to the effect seen with placebo
through study completion, up to 8 days
Eligibility criteria
Inclusion Criteria: * Age 18+ * Undergoing pulmonary resection (includes metastasectomy as well as anatomic resections) * Must have device with email capabilities for follow up survey Exclusion Criteria: * Requiring narcotic pain medication or Gabapentin at the time of preoperative appointment or within 30 days of surgery * Renal impairment requiring dialysis * Allergy to Gabapentin
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'SUPPORTIVE_CARE', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 0, 'type': 'ACTUAL'}}
Updated at
2023-04-13

1 organization

1 product

2 indications

Organization
M.D. Anderson Cancer Center
Product
Gabapentin
Indication
Thoracic
Indication
Pulmonary Disease