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IRCT20190107042264N2 IRCT 2020-11-27 Ahvaz University of Medical Sciences Comparison of Ropivacaine against Ropivacaine and Dexmedetomidine on postoperative pain Comparison of ultrasound guided intercostal nerve block with ropivacaine against Ropivacaine and Dexmedetomidine on reduction of postoperative pain in patients undergoing thoracotomy: a randomized clinical trial 2020-10-22 anticipated 74 Complete https://irct.ir/trial/50925 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Using Research Randomizer(freely available at www.randomizer.org) 74 random numbers are generated. this unsorted series of numbers are then used to assign coded drugs to patients, Blinding description: After obtaining a series of unsorted random numbers from the website, the numbers are used to divide consecutive patients into two groups. This data is then given to the anesthesiologist in charge of the study. This specialist, who is aware of patient assignments, Prepares study medications for injection in a transparent syringe, labeled with the code of each patient and provides them to a second anesthesiologist. this second anesthesiologist, who is unaware of the contents of the syringe then puts patients, who are unaware of the used medications, under intercostal nerve block. Patients are then transferred to the intensive care unit and monitored. Here, the patient data is collected in coded forms by the data collection team, who are unaware of patient assignment to groups. This information is provided to the statistical analyzer in numbered forms along with the information related to the assignment to the groups for statistical analysis. 3 Post Thoracotomy Pain. Intervention 1: Intervention group: At the end of the thoracotomy operation, after extubation in recovery and after hemodynamic stability, Intercostal nerve block under ultrasound guidance (model: M7 made by MindRay company, China) is performed by Pain Fellowship. The intercostal block is performed in supine position and along the posterior axillary line. The ultrasound probe is placed sagitally and after identifying the External, Internal and innermost intercostal muscles, using the Quinke Spinal Needle No. 22 (made by Dr. Japan, Japan), Injection for the intercostal nerve block is done in one space above and two spaces below the surgical incision site. In the Intervention Group Ropivacaine (5 cc of 0.25% solution; made by Molteni Farmaceutici, Italy) plus dexmedetomidine 0.5 mcg per kilogram body weight (Medonex, Exir Pharmaceutical Co., Iran) is used, Divided between the three spaces. Intervention 2: Control group: At the end of thoracotomy and after extubation and hemodynamic stability, in the recovery room, intercostal nerve block under ultrasound guidance (model: M-7 made by Mindray, China) is performed by pain fellowship. The intercostal block is performed in the supine position and along the posterior axillary line. The ultrasound probe is placed sagittally and after identifying the External, Internal and innermost intercostal muscles, using the Quinke Spinal Needle No. 22 (made by Dr. Japan, Japan) Injection for the intercostal nerve block is done in one space above and two spaces below the surgical incision site. In the control group, Ropivacaine (5 cc of 0.25% solution; made by Molteni Farmaceutici, Italy), is used, Divided between the three spaces. 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 No Specific Plan of action exists regarding the matter
public Kamran Mahmoudi
Imam Khomeini Hospital - Shahid Ahvazian Street - Azadegan Street
Ahvaz Iran (Islamic Republic of) 6193673111 +98 61 3222 2114 mahmoudi-k@ajums.ac.ir Ahvaz University of Medical Sciences scientific Kamran Mahmoudi
Imam Khomeini Hospital - Shahid Ahvazian Street - Azadegan Street
Ahvaz Iran (Islamic Republic of) 6193673111 +98 61 3222 2114 mahmoudi-k@ajums.ac.ir Ahvaz University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) American Society of Anesthesiologists physical status Class I, II or III Body Mass Index less than 40 No History of Alcohol or Drug abuse Not pregnant/Breastfeeding No history of coagulation problems or use of anticoagulants Ejection Fraction more than 30% No history of cardiac conduction block (except for first-degree cardiac block and controlled atrial fibrillation) No acute or chronic hepatitis No history of psychiatric illness No Need for renal supplementation or a history of kidney failure No Known Neuropathy 18 years 60 years Both Hypersensitivity to study drugs G89.12 Acute post-thoracotomy pain Treatment - Drugs Treatment - Drugs Intervention group: At the end of the thoracotomy operation, after extubation in recovery and after hemodynamic stability, Intercostal nerve block under ultrasound guidance (model: M7 made by MindRay company, China) is performed by Pain Fellowship. The intercostal block is performed in supine position and along the posterior axillary line. The ultrasound probe is placed sagitally and after identifying the External, Internal and innermost intercostal muscles, using the Quinke Spinal Needle No. 22 (made by Dr. Japan, Japan), Injection for the intercostal nerve block is done in one space above and two spaces below the surgical incision site. In the Intervention Group Ropivacaine (5 cc of 0.25% solution; made by Molteni Farmaceutici, Italy) plus dexmedetomidine 0.5 mcg per kilogram body weight (Medonex, Exir Pharmaceutical Co., Iran) is used, Divided between the three spaces. Control group: At the end of thoracotomy and after extubation and hemodynamic stability, in the recovery room, intercostal nerve block under ultrasound guidance (model: M-7 made by Mindray, China) is performed by pain fellowship. The intercostal block is performed in the supine position and along the posterior axillary line. The ultrasound probe is placed sagittally and after identifying the External, Internal and innermost intercostal muscles, using the Quinke Spinal Needle No. 22 (made by Dr. Japan, Japan) Injection for the intercostal nerve block is done in one space above and two spaces below the surgical incision site. In the control group, Ropivacaine (5 cc of 0.25% solution; made by Molteni Farmaceutici, Italy), is used, Divided between the three spaces. Pain. Timepoint: Immediately after return to Surgical Intensive Care Unit (ICU) from post surgical recovery, then again after 6, 12, 24 and 48 hours from return to surgical ICU. Method of measurement: Visual Analog Scale. Systolic Blood Pressure. Timepoint: Immediately after return to Surgical Intensive Care Unit (ICU) from post surgical recovery, then again after 6, 12, 24 and 48 hours from return to surgical ICU. Method of measurement: Aneroid Sphygmomanometer. Pulse Rate. Timepoint: Immediately after return to Surgical Intensive Care Unit (ICU) from post surgical recovery, then again after 6, 12, 24 and 48 hours from return to surgical ICU. Method of measurement: Pulse Oxymeter. Oxygen Saturation. Timepoint: Immediately after return to Surgical Intensive Care Unit (ICU) from post surgical recovery, then again after 6, 12, 24 and 48 hours from return to surgical ICU. Method of measurement: Pulse Oxymeter. Diastolic Blood Pressure. Timepoint: Immediately after return to Surgical Intensive Care Unit (ICU) from post surgical recovery, then again after 6, 12, 24 and 48 hours from return to surgical ICU. Method of measurement: Aneroid Sphygmomanometer. Ahvaz University of Medical Sciences Approved 2020-02-10 Ethics committee of Ahvaz Jundishapur University of Medical Sciences Faculty of Medicine, Ahvaz Jundishapur University of Medical Sciences, Esfand Street, Golestan, Ahvaz, Iran Ahvaz Khouzestan Iran (Islamic Republic of)