Ignite Creation Date:
2025-12-24 @ 1:18 PM
Ignite Modification Date:
2025-12-30 @ 2:27 PM
Study NCT ID:
NCT06367595
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-29
First Post:
2024-02-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Intrathecal Magnesium Sulfate Versus Intravenous Magnesium Sulfate on Postoperative Pain After Abdominal Hysterectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D008278', 'term': 'Magnesium Sulfate'}], 'ancestors': [{'id': 'D017616', 'term': 'Magnesium Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D013431', 'term': 'Sulfates'}, {'id': 'D013464', 'term': 'Sulfuric Acids'}, {'id': 'D013456', 'term': 'Sulfur Acids'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-06', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2026-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-05-27', 'studyFirstSubmitDate': '2024-02-20', 'studyFirstSubmitQcDate': '2024-04-12', 'lastUpdatePostDateStruct': {'date': '2024-05-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'effect on postoperative pain after abdominal hysterectomy using visual analog score', 'timeFrame': 'Baseline', 'description': 'the pain intensity assessment at rest and on movement (from lying to sitting on the bed) using Visual analog score (VAS) This will measure pain intensity from 0 to 10 (goal is to be \\< 4) 0: no pain 3: mild pain 7: moderate pain 10: severe pain'}], 'secondaryOutcomes': [{'measure': 'sedation by Ramsay sedation scale', 'timeFrame': 'Baseline', 'description': 'From 1 to 6\n\n1. Patient is anxious and agitated or restless, or both.\n2. Patient is cooperative, oriented, and tranquil.\n3. Patient responds to commands only.\n4. Patient exhibits brisk response to light glabellar tab or loud auditory stimulus.\n5. Patient exhibits a sluggish response to light glabellar tap or loud auditory stimulus.\n6. Patient exhibits no response.'}, {'measure': 'time of the first opioid request', 'timeFrame': 'Baseline', 'description': 'time of the first opioid request, concentration and the occurrence of complications (hypotension, bradycardia, itching, urinary retention.) all over 24 hours postoperatively.'}, {'measure': 'Mean arterial blood pressures (MAP)', 'timeFrame': 'Baseline', 'description': 'mean arterial blood pressures (MAP) will be recorded at time 0 then every 15 minutes in the first 2 hours, then at 6, 12, 24 hours postoperatively.'}, {'measure': 'Heart rate (HR)', 'timeFrame': 'Baseline', 'description': 'Heart rate (HR) will be recorded at time 0 then every 15 minutes in the first 2 hours, then at 6, 12, 24 hours postoperatively.'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Abdominal Hysterectomy']}, 'referencesModule': {'references': [{'pmid': '22239844', 'type': 'BACKGROUND', 'citation': 'Brandsborg B. Pain following hysterectomy: epidemiological and clinical aspects. Dan Med J. 2012 Jan;59(1):B4374.'}, {'pmid': '21057617', 'type': 'BACKGROUND', 'citation': 'Kim TK, Yoon JR. Comparison of the neuroendocrine and inflammatory responses after laparoscopic and abdominal hysterectomy. Korean J Anesthesiol. 2010 Oct;59(4):265-9. doi: 10.4097/kjae.2010.59.4.265. Epub 2010 Oct 21.'}, {'pmid': '11049915', 'type': 'BACKGROUND', 'citation': 'Wu CL, Fleisher LA. Outcomes research in regional anesthesia and analgesia. Anesth Analg. 2000 Nov;91(5):1232-42. doi: 10.1097/00000539-200011000-00035. No abstract available.'}, {'pmid': '9768789', 'type': 'BACKGROUND', 'citation': 'Camu F, Van Aken H, Bovill JG. Postoperative analgesic effects of three demand-dose sizes of fentanyl administered by patient-controlled analgesia. Anesth Analg. 1998 Oct;87(4):890-5. doi: 10.1097/00000539-199810000-00027.'}, {'pmid': '20014598', 'type': 'BACKGROUND', 'citation': 'Koltka K, Uludag E, Senturk M, Yavru A, Karadeniz M, Sengul T, Ozyalcin S. Comparison of equipotent doses of ropivacaine-fentanyl and bupivacaine-fentanyl in spinal anaesthesia for lower abdominal surgery. Anaesth Intensive Care. 2009 Nov;37(6):923-8. doi: 10.1177/0310057X0903700606.'}, {'pmid': '12198056', 'type': 'BACKGROUND', 'citation': 'Buvanendran A, McCarthy RJ, Kroin JS, Leong W, Perry P, Tuman KJ. Intrathecal magnesium prolongs fentanyl analgesia: a prospective, randomized, controlled trial. Anesth Analg. 2002 Sep;95(3):661-6, table of contents. doi: 10.1097/00000539-200209000-00031.'}, {'pmid': '23669270', 'type': 'BACKGROUND', 'citation': 'De Oliveira GS Jr, Castro-Alves LJ, Khan JH, McCarthy RJ. Perioperative systemic magnesium to minimize postoperative pain: a meta-analysis of randomized controlled trials. Anesthesiology. 2013 Jul;119(1):178-90. doi: 10.1097/ALN.0b013e318297630d.'}, {'pmid': '23904932', 'type': 'BACKGROUND', 'citation': 'Do SH. Magnesium: a versatile drug for anesthesiologists. Korean J Anesthesiol. 2013 Jul;65(1):4-8. doi: 10.4097/kjae.2013.65.1.4. Epub 2013 Jul 19.'}, {'pmid': '18554299', 'type': 'BACKGROUND', 'citation': 'Ishii H, Kohno T, Yamakura T, Ikoma M, Baba H. Action of dexmedetomidine on the substantia gelatinosa neurons of the rat spinal cord. Eur J Neurosci. 2008 Jun;27(12):3182-90. doi: 10.1111/j.1460-9568.2008.06260.x. Epub 2008 Jun 1.'}, {'pmid': '12678572', 'type': 'BACKGROUND', 'citation': 'Shang AB, Gan TJ. Optimising postoperative pain management in the ambulatory patient. Drugs. 2003;63(9):855-67. doi: 10.2165/00003495-200363090-00002.'}, {'pmid': '30211382', 'type': 'BACKGROUND', 'citation': 'Delgado DA, Lambert BS, Boutris N, McCulloch PC, Robbins AB, Moreno MR, Harris JD. Validation of Digital Visual Analog Scale Pain Scoring With a Traditional Paper-based Visual Analog Scale in Adults. J Am Acad Orthop Surg Glob Res Rev. 2018 Mar 23;2(3):e088. doi: 10.5435/JAAOSGlobal-D-17-00088. eCollection 2018 Mar.'}, {'pmid': '22539644', 'type': 'BACKGROUND', 'citation': "Khan BA, Guzman O, Campbell NL, Walroth T, Tricker JL, Hui SL, Perkins A, Zawahiri M, Buckley JD, Farber MO, Ely EW, Boustani MA. Comparison and agreement between the Richmond Agitation-Sedation Scale and the Riker Sedation-Agitation Scale in evaluating patients' eligibility for delirium assessment in the ICU. Chest. 2012 Jul;142(1):48-54. doi: 10.1378/chest.11-2100."}, {'pmid': '17695343', 'type': 'BACKGROUND', 'citation': 'Faul F, Erdfelder E, Lang AG, Buchner A. G*Power 3: a flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behav Res Methods. 2007 May;39(2):175-91. doi: 10.3758/bf03193146.'}, {'pmid': '35918860', 'type': 'BACKGROUND', 'citation': 'Yazdi AP, Esmaeeli M, Gilani MT. Effect of intravenous magnesium on postoperative pain control for major abdominal surgery: a randomized double-blinded study. Anesth Pain Med (Seoul). 2022 Jul;17(3):280-285. doi: 10.17085/apm.22156. Epub 2022 Jul 28.'}, {'pmid': '33762190', 'type': 'BACKGROUND', 'citation': 'Benevides ML, Fialho DC, Linck D, Oliveira AL, Ramalho DHV, Benevides MM. Intravenous magnesium sulfate for postoperative analgesia after abdominal hysterectomy under spinal anesthesia: a randomized, double-blind trial. Braz J Anesthesiol. 2021 Sep-Oct;71(5):498-504. doi: 10.1016/j.bjane.2021.01.008. Epub 2021 Mar 21.'}]}, 'descriptionModule': {'briefSummary': 'The present study aims to compare the effect of adding IV magnesium sulfate versus magnesium sulfate to intrathecal hyperbaric bupivacaine in total abdominal hysterectomy regarding the duration of postoperative analgesia, hemodynamic stability, and complications.', 'detailedDescription': 'Abdominal Hysterectomy (AH) is associated with an intense inflammatory response that can result in moderate to severe postoperative pain, sometimes difficult to control.\n\nPostoperative pain can cause many complications such as restlessness, increased sympathetic activity, high blood pressure, and tachycardia. Opioids are effective analgesics; however, they produce unwanted side effects, such as respiratory depression, nausea, and vomiting. Nonopioid drugs can decrease opioid usage and dependency.\n\nDifferent adjuvants have been added to local anesthetics to increase the duration of the regional anesthesia, decrease pain-relieving drugs, and delay the onset of postoperative pain.\n\nAccording to numerous reports, Magnesium sulfate has analgesic effects and lowers opioid consumption in many surgeries especially abdominal surgeries.\n\nThe analgesic properties of magnesium are based on acting as a non-competitive antagonist of N-Methyl-D-Aspartate (NMDA) receptors in central nervous system and regulating the calcium influx into the cell. These properties avoid the central sensitization mechanisms due to the stimulation of peripheral nociceptive nerves In the spinal cord, magnesium sulfate decreases pain transmission by hyperpolarizing spinal interneurons via G-protein-mediated activation of potassium channels and by decreasing the release of the neurotransmitters (substance P and glutamate) from primary afferent terminals.\n\nAdequate postoperative pain relief can enhance recovery and increase patient satisfaction.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '40 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients between 40-65 years old\n* Patients with ASA clinical status I/II\n* Patients eligible for abdominal hysterectomy\n* Oncological surgery\n\nExclusion Criteria:\n\n* Body mass index (BMI) ≥ 40/kg / m2\n* Previous abdominal surgery (except cesarean section)\n* Severe cardiovascular, renal, and hepatic dysfunction\n* Contraindications to spinal anesthesia\n* Neuromuscular diseases\n* Inappropriate for spinal anesthesia\n* Patient refusal'}, 'identificationModule': {'nctId': 'NCT06367595', 'briefTitle': 'Effect of Intrathecal Magnesium Sulfate Versus Intravenous Magnesium Sulfate on Postoperative Pain After Abdominal Hysterectomy', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Effect of Intrathecal Magnesium Sulfate Versus Intravenous Magnesium Sulfate on Postoperative Pain After Abdominal Hysterectomy', 'orgStudyIdInfo': {'id': 'Intrathecal MgSO4'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'intrathecal', 'description': 'will include 30 patients who will receive\n\n* Intrathecal hyperbaric bupivacaine 0.5 % 20 mg in 4 ml plus magnesium sulfate 30 mg of 0.5 ml volume.\n* 250 ml of isotonic saline infusion over 15 minutes immediately before spinal anesthesia, then 250 ml of isotonic saline infusion over 2 hours.', 'interventionNames': ['Drug: Magnesium sulfate']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'intravenous', 'description': 'will include 30 patients who will receive\n\n\\- 30 mg/kg magnesium sulfate at a concentration of 100 mg/ml (regarding the ideal body weight) in 250 ml of isotonic saline infusion over 15 minutes immediately before spinal anesthesia (intrathecal hyperbaric bupivacaine 0.5 % 20 mg in 4 ml plus 0.5 ml of isotonic saline), and then 10 mg/kg/h magnesium sulfate in 250 ml isotonic saline infusion over 2 hours.', 'interventionNames': ['Drug: Magnesium sulfate']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'description': 'will include 30 patients who will receive\n\n* intrathecal hyperbaric bupivacaine 0.5 % 20 mg in 4 ml plus 0.5 ml of isotonic saline.\n* 250 ml of isotonic saline infusion over 15 minutes immediately before spinal anesthesia then 250 ml of isotonic saline infusion over 2 hours.', 'interventionNames': ['Drug: Magnesium sulfate']}], 'interventions': [{'name': 'Magnesium sulfate', 'type': 'DRUG', 'description': 'IV magnesium sulfate versus magnesium sulfate to intrathecal hyperbaric bupivacaine', 'armGroupLabels': ['intrathecal', 'intravenous', 'placebo']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Marwa S Hassanein, Res', 'role': 'CONTACT', 'email': 'marwasalah2525@gmail.com', 'phone': '00201159511004'}, {'name': 'Ahmed M Elsonbaty, Lecturer', 'role': 'CONTACT', 'email': 'elsonbatyahmed89@gmail.com', 'phone': '00201011403456'}], 'overallOfficials': [{'name': 'Hamdy A Youssef, Professor', 'role': 'STUDY_CHAIR', 'affiliation': 'Assuit University Hospital'}, {'name': 'Mohamed F Mostafa, Ass professor', 'role': 'STUDY_CHAIR', 'affiliation': 'Assuit University Hospital'}, {'name': 'Ahmed M Elsonbaty, Lecturer', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Assuit University Hospital'}, {'name': 'Marwa S Hassanein, Resident', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assuit University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'principal investigator', 'investigatorFullName': 'Marwa Salah Hassanein', 'investigatorAffiliation': 'Assiut University'}}}}