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IRCT2015092824252N1 IRCT 2016-05-20 Vice Chancellor for research of Birjand University of Medical Sciences Effects of the timing of tourniquet release in orthopedic surgery The impact of timing of tourniquet release on knee range of motion of patients with plating of tibia fractures: a randomized controlled trial 2016-01-21 anticipated 40 Complete https://irct.ir/trial/20517 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Other design features: Through block randomization, blocks of individuals are selected, and treatment protocol is randomly allocated to them. 2 Condition 1: Fracture. Condition 2: Fracture. Condition 3: Fracture. Intervention 1: Intervention group 1: Cuff of tourniquet will be applied on the most muscular part of the femur before surgery prep. The tourniquet used involves the MICROBACE pneumatic tourniquet system with the length of 75 cm and width of 15 cm, which will be applied between the skin and cuff over three layers of cast padding. After raising limb for 3 minutes and draining the blood, a pressure of 150 mm Hg higher than systolic blood pressure will be applied. Upon fracture reduction and fixation with plat and screws, tourniquet will be opened during surgery and before closing the wound. Intervention 2: Cuff of tourniquet will be applied on the most muscular part of the femur before surgery prep. The tourniquet used involves the MICROBACE pneumatic tourniquet system with the length of 75 cm and width of 15 cm, which will be applied between the skin and cuff over three layers of cast padding. After raising limb for 3 minutes and draining the blood, a pressure of 150 mm Hg higher than systolic blood pressure will be applied. Upon fracture reduction and fixation with plat and screws, the skin and other anatomical layers will be stitched and tourniquet will be opened after closing the wound and applying compression bandage.
public Maryam Khodabakhshi
Imam Reza Hospital, Ayatollah Taleghani Street
Birjand Iran (Islamic Republic of) +98 56 3222 2300 khodabakhshim2013@gmail.com; mkhodabakhshi@bums.ac.ir Birjand University of Medical Sciences scientific Reza Bahador
Birjand University of Medical Sciences, Ayatollah Ghaffari Street
Birjand Iran (Islamic Republic of) 9717853577 +98 56 3239 5000 rezamdbahador@gmail.com Birjand University of Medical Sciences Iran (Islamic Republic of) Inclusion criteria: Age over 18 years and less than 55 years; doing surgery within the first week after fracture; closed and extraarticular tibia fracture; absence of another fracture in any of the limbs; absence of chest, head or abdomen trauma; absence of vascular and nerve damage, the compartment syndrome and a history of previous surgery on the lower limbs; absence of clotting problems, peripheral vascular disease, peripheral neuropathy and pre-operative DVT limb; non-use of steroidal and non-steroidal anti-inflammatory drugs, anticoagulation, chemotherapy, smoking and narcotics; systolic blood pressure less than 20 mm Hg; body mass index less than 30; knee range of motion of more than 135 degrees Exclusion criteria: Tourniquet time greater than 90 minutes; need for re-operation; patient’s reluctance to cooperate in any stage of the study; patient’s death 18 years 55 years Both S82.1 S82.2 S82.3 Fracture of upper end of tibia Fracture of shaft of tibia Fracture of lower end of tibia Treatment - Surgery Treatment - Surgery Intervention group 1: Cuff of tourniquet will be applied on the most muscular part of the femur before surgery prep. The tourniquet used involves the MICROBACE pneumatic tourniquet system with the length of 75 cm and width of 15 cm, which will be applied between the skin and cuff over three layers of cast padding. After raising limb for 3 minutes and draining the blood, a pressure of 150 mm Hg higher than systolic blood pressure will be applied. Upon fracture reduction and fixation with plat and screws, tourniquet will be opened during surgery and before closing the wound. Cuff of tourniquet will be applied on the most muscular part of the femur before surgery prep. The tourniquet used involves the MICROBACE pneumatic tourniquet system with the length of 75 cm and width of 15 cm, which will be applied between the skin and cuff over three layers of cast padding. After raising limb for 3 minutes and draining the blood, a pressure of 150 mm Hg higher than systolic blood pressure will be applied. Upon fracture reduction and fixation with plat and screws, the skin and other anatomical layers will be stitched and tourniquet will be opened after closing the wound and applying compression bandage. Knee Range of Motion. Timepoint: Before surgery, 24 hours and 14 days after surgery. Method of measurement: Goniometer. Wound healing. Timepoint: preoperatively, 24 hours and 14 days after operation. Method of measurement: REEDA scale. Pain. Timepoint: Before surgery, 24 hours and 14 days after surgery. Method of measurement: Visual Analogue Scale. Vice Chancellor for research of Birjand University of Medical Sciences Approved 2016-01-11 Ethics Committee of Birjand University of Medical Sciences Ayatollah Ghaffari Street Birjand Iran (Islamic Republic of)