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IRCT20190421043336N1 IRCT 2019-09-18 Sanandaj University of Medical Sciences Analgesic efficacy of dexmedetomidine in patients undergoing inguinal hernioraphy Comparing the analgesic efficacy of adding different doses of dexmedetomidine to bupivacaine in ultrasound-guided Transversus Abdominis Plane (TAP) block in patients undergoing open inguinal hernioraphy 2019-07-23 anticipated 75 Complete https://irct.ir/trial/40938 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Block randomization works by randomizing participants within blocks such that an equal number are assigned to each treatment. In this study we randomly assign the patients to 6 separate blocks (with equal numbers) and perform the first type of treatment (0.5 mcg/kg dexmedetomidine) on the blocks 1 and 4, the second type of treatment (1 mcg/kg dexmedetomidine) on the blocks 2 and 5, and the third type of treatment (1.5 mcg/kg dexmedetomidine) on the blocks 3 and 6. To achieve the necessary power for the study, each block has at least 13 patients (at least 78 patients total), Blinding description: In this double-blind clinical trial, although the patients will be aware of the type of medication that being used for them, they will not know what strength will be used for them. The anesthesiologist will perform the injection according to the patients corresponding treatment group. The questionnaire for evaluating the effectiveness of the treatment will be filled by an anesthesiology resident who is not aware of the patients treatment group. 4 Inguinal hernia. Intervention 1: Intervention group: The injectable solution is 19ml of Bupivacaine combined with 0.5 mcg/kg dexmedetomidine solution in 1 ml normal Saline. Intervention 2: Intervention group: The injectable solution is 19ml of Bupivacaine combined with 1 mcg/kg dexmedetomidine solution in 1 ml normal Saline. Intervention 3: Intervention group: The injectable solution is 19ml of Bupivacaine combined with 1.5 mcg/kg dexmedetomidine solution in 1 ml normal Saline. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is I haven't decided yet.
public Karim Naseri
Pasdaran Blvd.
Sanandaj Iran (Islamic Republic of) 6617713446 +98 87 3366 4664 bihoshi@gmail.com Sanandaj University of Medical Sciences scientific Karim Naseri
Pasdaran Blvd.
Sanandaj Iran (Islamic Republic of) 6617713446 +98 87 3366 4664 bihoshi@gmail.com Sanandaj University of Medical Sciences Iran (Islamic Republic of) Signing the informed consent by the patient Age between 18 - 75 years Class 1 or Class 2 according to American Society of Anesthesiologists (ASA) physical status classification 18 years 75 years Both History of substance abuse Presence of pain in the operation site before surgery History of psychological disorders History of high blood pressure or history of anti-hypertensive medication History of heart disease (Ischemic Heart disease, Heart valve disease, heart blocks) History of kidney failure History of hypersensitivity to the medications intended to be used in the study Being illiterate or lacking the capacity to understand Visual Analogue Pain Scale K40 Inguinal hernia Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group: The injectable solution is 19ml of Bupivacaine combined with 0.5 mcg/kg dexmedetomidine solution in 1 ml normal Saline. Intervention group: The injectable solution is 19ml of Bupivacaine combined with 1 mcg/kg dexmedetomidine solution in 1 ml normal Saline. Intervention group: The injectable solution is 19ml of Bupivacaine combined with 1.5 mcg/kg dexmedetomidine solution in 1 ml normal Saline. The patient's pain level, assessed by the use of Visual Analogue Pain Scale. Timepoint: At 2, 4, 8, 12, and 24 hours after the end of surgery. Method of measurement: Visual Analogue Pain Scale. The first time patient needs analgesic. Timepoint: The first time patient asks for analgesic after the end of surgery. Method of measurement: Number of hours between end of surgery and the first time patient asks for analgesic. Sanandaj University of Medical Sciences Approved 2019-03-16 Ethics committee of Kurdistan University of Medical Sciences Deputy of Research and Technology of Kurdistan University of Medical Sciences, Pasdaran Boulevard Sanandaj Kurdistan Iran (Islamic Republic of)