]>
IRCT20180922041088N1 IRCT 2018-12-28 Iran University of Medical Sciences Effects of nitroglycerine (TNG) in intravenous pain control pump Effects of adding trinitroglycerin (TNG) to the patient controlled intravenous analgesia pump in patients with lower limb orthopedic surgery 2017-09-01 anticipated 75 Complete https://irct.ir/trial/34112 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: First, individuals who have the characteristics necessary to enter the study are usually taken from a non-random sample using a simple sampling method. Then, randomization is done between study groups. In this study, a block randomization method (including 4 blocks) is used. One of the study partners who has not been blindfolded, named pain pump with and without TNG with the letters A and B. Then, the researcher will distribute A and B packages among patients in a randomized block method (ABAB, BABA, AABB, BBAA, ABBA, BAAB; A, first person; B, Second person; A, third person; B,fourth person B etc.). Then, selecting the blocks are continued until reaching the sample size. Random sequence generation was done using simple randomization. To construct a random sequence to the possible blocks (6 blocks), we give numbers to them from one to six numbers. According to the sample size, each number of 4 blocks required will be used. the number of blocks was chosen from the random numbers table and based on these numbers we identified the sequence of blocks in each group, Blinding description: In this study blinding will be as follows: Researcher and data collector are the same and are blinded and unaware of the contents of the pain pumps. Patients: Are blinded because they are unaware of the contents of the pain pump. Blinding: Based on the sequence of random numbers, group A or B will be placed inside sealed envelopes. A researcher who does not know the contents and sequence of envelopes will open the envelopes accordingly, and based on the fact that A or B has arrived, they will use a pre-filled pump A or B, respectively. One of the members of the research team has put the A label or label B on the pumps (only the same person is aware of the contents inside the pump). 3 pain control after surgery. Intervention 1: First intervention group: Patients will use 500 microgram (mcg) Trinitroglycerin (TNG)-containing pain pump to reduce pain after lower limb orthopedic surgery. (Nitral, Caspian Tamin Pharmaceutical Co.). Intervention 2: Control group: Patients will use without Trinitroglycerin (TNG)-containing pain pump to reduce pain after lower limb orthopedic surgery. Intervention 3: Second intervention group: Patients will use 1000 microgram (mcg) Trinitroglycerin (TNG)-containing pain pump to reduce pain after lower limb orthopedic surgery. (Nitral, Caspian Tamin Pharmaceutical Co.). 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 We have not yet set a conclusion
public Poupak Rahimzadeh
Fifth floor, Central staff, Iran University of Medical Sciences, Hemmat Highway
Tehran Iran (Islamic Republic of) 1916737183 +98 21 8670 2503 p-rahimzadeh@tums.ac.ir Iran University of Medical Sciences scientific Poupak Rahimzadeh
Fifth floor, Central staff, Iran University of Medical Sciences, Hemmat Highway
Tehran Iran (Islamic Republic of) 1916737183 +98 21 8670 2503 p-rahimzadeh@tums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) Lower extremities orthopedic patients Spinal anesthesia with 15 milligram (mg) bupivacain 0.5% Patients with American Society of Anesthesiologists (ASA) I,II 18 years 50 years Both Addiction to alcohol, benzodiazepines and opium. Heart failure Patients dissatisfaction Allergies to any of used drugs Seizure Valvular heart disease Arrhythmia M79.6 Pain in limb, hand, foot, fingers and toes Treatment - Drugs Treatment - Drugs Treatment - Drugs First intervention group: Patients will use 500 microgram (mcg) Trinitroglycerin (TNG)-containing pain pump to reduce pain after lower limb orthopedic surgery. (Nitral, Caspian Tamin Pharmaceutical Co.) Control group: Patients will use without Trinitroglycerin (TNG)-containing pain pump to reduce pain after lower limb orthopedic surgery Second intervention group: Patients will use 1000 microgram (mcg) Trinitroglycerin (TNG)-containing pain pump to reduce pain after lower limb orthopedic surgery. (Nitral, Caspian Tamin Pharmaceutical Co.) Pain after lower limb orthopedic surgery. Timepoint: 4, 8, 12 and 24 hours after surgery. Method of measurement: Using Visual Analogue Scale. Complications. Timepoint: During 24 hours after surgery. Method of measurement: With physical examination. Need for adjuvant analgesic. Timepoint: During 24 hours using pain pump. Method of measurement: Using questionnaire information. Iran University of Medical Sciences Approved 2017-11-01 Ethics Committee of Iran University of Medical Sciences Iran University of Medical Sciences., next to Milad Tower., Hemmat Highway Tehran Tehran Iran (Islamic Republic of)