Ignite Creation Date:
2025-12-24 @ 1:41 PM
Ignite Modification Date:
2025-12-27 @ 10:17 PM
Study NCT ID:
NCT05150795
Status:
RECRUITING
Last Update Posted:
2025-01-29
First Post:
2021-10-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Preoperative Oral Pregabalin Versus Intraoperative Fentanyl on Postoperative Analgesia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}, {'id': 'D000377', 'term': 'Agnosia'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069583', 'term': 'Pregabalin'}], 'ancestors': [{'id': 'D005680', 'term': 'gamma-Aminobutyric Acid'}, {'id': 'D000613', 'term': 'Aminobutyrates'}, {'id': 'D002087', 'term': 'Butyrates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-27', 'studyFirstSubmitDate': '2021-10-08', 'studyFirstSubmitQcDate': '2021-12-08', 'lastUpdatePostDateStruct': {'date': '2025-01-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-12-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in post-operative pain score at rest over time', 'timeFrame': '1 hour', 'description': 'Intensity of pain will be monitored at 15 and 30min after arrival to the PACU, then 1h before discharge from the PACU. For analysis, pain severity will be categorized as absent (VAS=0), mild (VAS=1-3), moderate (VAS=4-7), severe (VAS=7-9), and very severe (VAS=10).'}, {'measure': 'Changes in post-operative pain score on coughing over time', 'timeFrame': '1 hour', 'description': 'Intensity of pain will be monitored at 15 and 30min after arrival to the PACU, then 1h before discharge from the PACU. For analysis, pain severity will be categorized as absent (VAS=0), mild (VAS=1-3), moderate (VAS=4-7), severe (VAS=7-9), and very severe (VAS=10).'}], 'secondaryOutcomes': [{'measure': 'Pre-operative level of patient sedation assessed by the sedation score', 'timeFrame': '1 hour', 'description': 'assessed 1 hour after administering the oral capsules by the sedation score from 0 to 4. 0=Awake and agitated, 1= Awake and comfortable, 2= Asleep and arousable, 3= Asleep with sluggish response to verbal commands or touch, 4= No response to verbal command or touch.'}, {'measure': 'Duration of surgery', 'timeFrame': '2 hours', 'description': 'Measured in minutes'}, {'measure': 'Duration of anesthesia', 'timeFrame': '3 hours', 'description': 'Measured in minutes'}, {'measure': 'mean values of systolic blood pressure (SBP)', 'timeFrame': '4 hours', 'description': 'mean values of SBP at pre-operative baseline, before induction of anesthesia, 5min after endotracheal intubation, before pneumoperitoneum, during the first 30 minutes (at 10, 20 and 30 min) of pneumoperitoneum, after release of pneumoperitoneum and 10 min after extubation in the PACU'}, {'measure': 'Intra-operative additional doses of fentanyl given', 'timeFrame': '3 hours', 'description': 'Rescue analgesia needed in micrograms'}, {'measure': 'Postoperative level of patient sedation', 'timeFrame': '1 hour', 'description': 'assessed by the sedation score from 0 to 4. 0=Awake and agitated, 1= Awake and comfortable, 2= Asleep and arousable, 3= Asleep with sluggish response to verbal commands or touch, 4= No response to verbal command or touch.'}, {'measure': 'Post-operative pain score', 'timeFrame': '12 hours', 'description': 'at rest and on coughing using the Visual Analogue Score (VAS) score from 0 to 10 where 0= no pain and 10 is the worst pain felt. Pain severity will be categorized as absent (VAS=0), mild (VAS=1-3), moderate (VAS=4-7), severe (VAS=7-9), and very severe (VAS=10).'}, {'measure': 'Pethidine requirements', 'timeFrame': '1 hour', 'description': 'Number of patients requiring pethidine in the PACU'}, {'measure': 'sPO2', 'timeFrame': '4 hours', 'description': 'recorded in the induction room and in the PACU'}, {'measure': 'changes in mean values of diastolic blood pressure (DBP)', 'timeFrame': '4 hours', 'description': 'mean values of DBP at pre-operative baseline, before induction of anesthesia, 5min after endotracheal intubation, before pneumoperitoneum, during the first 30 minutes (at 10, 20 and 30 min) of pneumoperitoneum, after release of pneumoperitoneum and 10 min after extubation in the PACU'}, {'measure': 'changes in mean values of mean blood pressure (MBP)', 'timeFrame': '4 hours', 'description': 'mean values of MBP,at pre-operative baseline, before induction of anesthesia, 5min after endotracheal intubation, before pneumoperitoneum, during the first 30 minutes (at 10, 20 and 30 min) of pneumoperitoneum, after release of pneumoperitoneum and 10 min after extubation in the PACU'}, {'measure': 'mean values of heart rate (HR)', 'timeFrame': '4 hours', 'description': 'mean values of HR at pre-operative baseline, before induction of anesthesia, 5min after endotracheal intubation, before pneumoperitoneum, during the first 30 minutes (at 10, 20 and 30 min) of pneumoperitoneum, after release of pneumoperitoneum and 10 min after extubation in the PACU'}, {'measure': 'total dose of pethidine given to the patient', 'timeFrame': '12 hours', 'description': 'total dose of pethidine given in milligrams will be recorded'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pregabalin', 'analgesia'], 'conditions': ['Post Operative Pain, Acute']}, 'descriptionModule': {'briefSummary': 'Pregabalin is a structural analogue of gamma amino butyric acid (GABA). It binds to presynaptic alpha-2-delta subunit of voltage gated calcium channels in the brain and the spinal cord. Thus, it modulates the release of excitatory neurotransmitters, such as glutamate, norepinephrine, substance-P, and calcitonin gene related peptide. Also, it causes inhibitory modulation of overexcited neurons and restores them to a normal state.\n\nPre-emptive analgesia aims to reduce postoperative opioid consumption especially in ambulatory surgeries. Pregabalin (PGB) is an emerging drug in this field. Different doses of preoperative oral pregabalin (75, 150 and 300 mg) are described in the literature with a dose-response analgesic relationship and reduction of opioid use; however increasing the dose results in increasing the incidence of side effects mainly sedation and dizziness.\n\nPerioperative use of opioids for analgesia may result in side effects; like nausea, vomiting, excessive sedation, respiratory depression, pruritus, and urinary retention.The concomitant use of opioids with pregabalin may result in excess sedation and somnolence, so, the use of opioids with pregabalin should be limited to patients with inadequate alternative options.', 'detailedDescription': "Our study aims to compare the postoperative analgesic effect of pre-operative oral pregabalin (Study group), to the intraoperative intravenous fentanyl (Control group) in diagnostic laparoscopic gynecologic surgery.\n\nPatienrs will be selected by simple randomization by computer generated system. Pregabalin 150 mg oral capsule and a placebo capsule will be available on the morning of operation.\n\nAlso, 2 syringes of 10 ml volumes will be prepared; the first contains normal saline and the second contains the fentanyl dose of 1 µg /kg calculated according to the patient's body weight and diluted to a 10 ml volume.\n\nPatients will then be divided into 2 equal groups of 40 patients each:\n\nGroup P: Patients will receive oral pregabalin capsule (150 mg) 90 min before induction of anesthesia, and will receive a bolus injection of 10 ml saline at induction of anesthesia.\n\nGroup F: Patients will receive oral placebo capsule identical to the trial drug in size, shape and color, 90 min before induction of anesthesia and will receive a bolus injection of 10 ml of 1µg /kg fentanyl at induction of anesthesia."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '21 Years', 'genderBased': True, 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* ASA physical status I\n\nExclusion Criteria:\n\n* Patients' refusal\n* use of sedatives, hypnotics, anti-psychotic or antidepressant drugs\n* history of drug/alcohol abuse\n* history of chronic pain\n* daily intake of analgesics\n* history of epilepsy"}, 'identificationModule': {'nctId': 'NCT05150795', 'briefTitle': 'Effect of Preoperative Oral Pregabalin Versus Intraoperative Fentanyl on Postoperative Analgesia', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'The Effect of Preoperative Oral Pregabalin and Intraoperative Fentanyl on Postoperative Analgesia in Diagnostic Laparoscopic Gynecologic Surgery: a Comparative Study', 'orgStudyIdInfo': {'id': 'R18/2020/2021'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group Pregabalin', 'description': 'Patients will receive oral pregabalin capsule (150 mg) 90 min before induction of anesthesia, and will receive a bolus injection of 10 ml saline at induction of anesthesia', 'interventionNames': ['Drug: Pregabalin 150mg']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group Fentanyl', 'description': 'Patients will receive oral placebo capsule identical to the trial drug in size, shape and color, 90 min before induction of anesthesia and will receive a bolus injection of 10 ml of 1µg /kg fentanyl at induction of anesthesia', 'interventionNames': ['Drug: Fentanyl 100 micrograms ampoule']}], 'interventions': [{'name': 'Pregabalin 150mg', 'type': 'DRUG', 'description': 'Compare the postoperative analgesic effect of pre-operative oral pregabalin (Study group), to the intraoperative intravenous fentanyl (Control group) in diagnostic laparoscopic gynecologic surgery.', 'armGroupLabels': ['Group Pregabalin']}, {'name': 'Fentanyl 100 micrograms ampoule', 'type': 'DRUG', 'description': 'Compare the postoperative analgesic effect of pre-operative oral pregabalin (Study group), to the intraoperative intravenous fentanyl (Control group) in diagnostic laparoscopic gynecologic surgery.', 'armGroupLabels': ['Group Fentanyl']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Ghada Mohamed Samir, MD', 'role': 'CONTACT', 'email': 'dr.ghada216@gmail.com', 'phone': '01005043691', 'phoneExt': '002'}], 'facility': 'Ain-Shams University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'Ghada Mohamed Samir, MD', 'role': 'CONTACT', 'email': 'dr.ghada216@gmail.com', 'phone': '01005043691', 'phoneExt': '002'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Anesthesia, Intensive care and Pain Management', 'investigatorFullName': 'Ghada M.Samir', 'investigatorAffiliation': 'Ain Shams University'}}}}