Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-30 @ 9:25 PM
Study NCT ID:
NCT07456761
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-06
First Post:
2026-03-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Low-dose Pregabalin Retard (82.5 mg) Versus Standard-dose Pregabalin Retard (165 mg) on Postoperative Pain and Opioid Consumption After Elective Laparoscopic Abdominal Surgery: a Randomized, Double-blind, Controlled Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-02', 'studyFirstSubmitDate': '2026-03-02', 'studyFirstSubmitQcDate': '2026-03-02', 'lastUpdatePostDateStruct': {'date': '2026-03-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cumulative opioid consumption (IV morphine equivalents) during the first 24 postoperative hours', 'timeFrame': '24 hours'}], 'secondaryOutcomes': [{'measure': 'Postoperative pain intensity', 'timeFrame': '2-24 hours postoperative', 'description': 'VAS (0-10) at rest and during movement at predefined time points (2,4, 6,8 12,18 and 24h).'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pregabalin', 'Pain scores', 'Total opioid consumption', 'Laparoscopic abdominal surgery'], 'conditions': ['Laparoscopic Abdominal Surgeries']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to detect whether pregabalin retard (82.5 mg or 165 mg) improves analgesia after elective laparoscopic abdominal surgery in adults. It will also evaluate the safety of both doses.\n\nThe main questions it aims to answer are:\n\nDoes the higher dose (165 mg) reduce the total amount of opioids needed in the first 24 hours after surgery compared to the lower dose (82.5 mg)? Do the pain scores differ between the two doses? Are there differences in side effects between the two doses?\n\nResearchers will compare two different doses of pregabalin retard to determine which provides better pain control with fewer side effects.\n\nParticipants will:\n\nTake one dose of pregabalin retard (82.5 mg or 165 mg) before surgery Receive standard anesthesia and multimodal pain treatment Have their pain levels and opioid use monitored for 24 hours after surgery Be assessed for side effects such as dizziness, nausea, or sedation'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18-75 years\n* ASA physical status I-III\n* Scheduled for elective laparoscopic abdominal surgery under general anesthesia (e.g. laparoscopic cholecystectomy, appendectomy, diagnostic/therapeutic laparoscopic procedures without expected conversion to open surgery)\n* Ability to understand the NRS pain scale and the study procedures\n* Written informed consent obtained\n\nExclusion Criteria:\n\n* Known allergy or intolerance to pregabalin, gabapentinoids, or study medications\n* Chronic opioid use (daily use \\>30 mg oral morphine equivalent for \\>2 weeks preoperatively)\n* Regular use of gabapentin or pregabalin within 30 days\n* Severe renal impairment (eGFR \\< 30 mL/min/1.73 m²) or on dialysis\n* Severe hepatic impairment (Child-Pugh C)\n* Uncontrolled epilepsy or other major neurological disorder\n* Severe psychiatric disease, alcohol or substance abuse\n* Pregnancy or breastfeeding\n* Planned postoperative ICU admission for reasons other than routine overnight monitoring\n* Conversion to open abdominal surgery (these patients will be analyzed in sensitivity or excluded, predefined in analysis plan)'}, 'identificationModule': {'nctId': 'NCT07456761', 'briefTitle': 'Effect of Low-dose Pregabalin Retard (82.5 mg) Versus Standard-dose Pregabalin Retard (165 mg) on Postoperative Pain and Opioid Consumption After Elective Laparoscopic Abdominal Surgery: a Randomized, Double-blind, Controlled Trial', 'organization': {'class': 'OTHER', 'fullName': 'South Egypt Cancer Institute'}, 'officialTitle': 'Effect of Low-dose Pregabalin Retard (82.5 mg) Versus Standard-dose Pregabalin Retard (165 mg) on Postoperative Pain and Opioid Consumption After Elective Laparoscopic Abdominal Surgery: a Randomized, Double-blind, Controlled Trial', 'orgStudyIdInfo': {'id': '18-2026-809'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group I (Low dose)', 'description': 'Participants of this Arm will take pregabalin retard 82.5 mg orally with a sip of water, 1-2 hours before induction of anesthesia.', 'interventionNames': ['Drug: Pregabalin retard 82.5 mg']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group II (High dose)', 'description': 'Participants of this Arm will take pregabalin retard 165 mg orally with a sip of water, 1-2 hours before induct', 'interventionNames': ['Drug: Pregabalin retard 165 mg']}], 'interventions': [{'name': 'Pregabalin retard 82.5 mg', 'type': 'DRUG', 'description': 'Oral Administration 1-2 hours before elective laparoscopic abdominal surgery', 'armGroupLabels': ['Group I (Low dose)']}, {'name': 'Pregabalin retard 165 mg', 'type': 'DRUG', 'description': 'Oral Administration 1-2 hours before elective laparoscopic abdominal surgery', 'armGroupLabels': ['Group II (High dose)']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'South Egypt Cancer Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer of anesthesia, intensive care medicine and pain therapy', 'investigatorFullName': 'Muhammad Gamal Thabet Ahmed', 'investigatorAffiliation': 'South Egypt Cancer Institute'}}}}