protocolSection identificationModule nctId: NCT06354478, orgStudyIdInfo id: ms-103-2021, briefTitle: IV Dexmedetomidine vs Oral Gabapentin and Their Combination for Postoperative Analgesia in Cancer Patients Undergoing Modified Radical Mastectomy, statusModule overallStatus: COMPLETED, startDateStruct date: 2021-01-01, primaryCompletionDateStruct date: 2022-02-01, completionDateStruct date: 2022-07-01, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: National Cancer Institute, Egypt, class: OTHER, descriptionModule briefSummary: Breast cancer is the most common malignant tumour among females with an incidence of about 2.1 million women every year.Nearly about 40-60% of breast surgery patients develop severe acute postoperative pain.⁴ Opioids are the current best standard drugs for postoperative pain relief, however, exposure to large doses of opioids leads to multiple side effects like prolonged sedation, respiratory depression, nausea, and vomiting.We are comparing two different drugs and their combination for perioperative analgesia for MRM.This work is a comparative study that aims to compare the analgesic effects of perioperative IV infusion of dexmedetomidine, preoperative oral gabapentin, and their combination in patients undergoing modified radical mastectomy surgery regarding the time of first rescue analgesia, postoperative morphine consumption, and possible complications., conditionsModule conditions: Breast Cancer, conditions: Pain, Postoperative, conditions: Pain, Acute, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, maskingDescription: Both patients and Investigator for postoperative pain will be blinded:* Group 1(D): (n=30) Patients will receive oral placebo starch capsules 1 hour preoperatively and intraoperative intravenous infusion of dexmedetomidine with general anaesthesia.* Group 2(G): (n=30) Patients will receive oral gabapentin capsules for 1 hour preoperatively and intraoperative intravenous saline infusion with general anaesthesia.* Group 3(DG): (n=30) Patients will receive oral gabapentin capsules for 1 hour preoperatively and intraoperative intravenous infusion of dexmedetomidine with general anaesthesia., whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 90, type: ACTUAL, armsInterventionsModule interventions name: Dexmedetomidine Hydrochloride 0.5 MG/ML, interventions name: Gabapentin, outcomesModule primaryOutcomes measure: The time to first rescue analgesia during the first 24 hour Postoperatively., secondaryOutcomes measure: Total postoperative morphine consumption till the first 24 hours, secondaryOutcomes measure: The degree of postoperative sedation according to Ramsay scores, secondaryOutcomes measure: VAS scores both at rest and during shoulder movement, secondaryOutcomes measure: Postoperative nausea and vomiting (PONV) as side effects of morphine., eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: National Cancer Institute, city: Cairo, country: Egypt, geoPoint lat: 30.06263, lon: 31.24967, hasResults: False