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IRCT20231211060337N1 IRCT 2024-01-08 Combined military hospital Comparison of ultrasound guided femoropopliteal block versus spinal anesthesia for ankle surgery Comparison of ultrasound guided femoropopliteal block versus spinal anesthesia for ankle surgery 2023-08-16 anticipated 190 Complete https://irct.ir/trial/74290 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The trail randomized all patients as per the inclusion criteria furnished. The patients were divided into the spinal group and the femoropopliteal block group. Once the patients were divided into the two groups, an informed written consent was taken, and patients in both groups were explained in detail about the procedure and possible complications. Standards monitoring including non-invasive blood pressure, heart rate, capnography and ECG were attached to participants in both groups. N/A Ankle surgery. Intervention 1: Control group: Spinal anesthesia was administered in Group S using a standard 27 G Braun spinal needle in the L3-L4 spinal space under strict aseptic measures by a consultant anesthetist and 0.5% hyperbaric bupivacaine using a volume of 2.5 ml was administered. Onset and quality of sensory and motor block was checked and re-assessed every 2 minutes using the modified Bromage scale for motor and cold spray method for check for sensory block integrity until an effective sensory level was achieved for spinal dermatomal level T12 and below and motor block effectiveness with a Bromage score of 1. Intervention 2: Control group: Patient in the femoropopliteal block group were administered the block in prone position for the popliteal block blocking the tibial and common peroneal nerves in the popliteal space using 15ml of 0.5%bupivacaine with 2mg dexamethasone. Patients were then turned supine and 5ml of 0.5%bupivacaine with 0.5mg dexamethasone was administered in the femoral sheath for the femoral block. Both the blocks were performed under strict aseptic measures by a consultant pain specialist following standard guidelines furnished by NYSORA. Onset of the block was checked and re-assessed every two minutes until sensory and motor blocks were achieved as in the spinal group. 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 This will be decided at the end of the study. There is no further information.
public Afzal shabbir
Itefaq town nai abadi kirpa road islamabad
Rawalpindi Pakistan 46000 +92 313 5158969 afzalshabbir68@gamil.com Armed Forces Post Graduate Medical Institute scientific Afzal shabbir
Itefaq town nai abadi kirpa road islamabad
Rawalpindi Pakistan 46000 +92 313 5158969 afzalshabbir68@gamil.com Armed Forces Post Graduate Medical Institute Pakistan Included all ASA-I and II male and female patients between ages 25-55 years presenting for surgical fixation of malleolar fracture of the ankle. 25 years 55 years Both Included patients with major cardiac or respiratory disease, patients with failed spinal or femoropopliteal block after three unsuccessful attempts. Patients allergic to local anesthetics including bupivacaine , lignocaine and steroids including dexamethasone. Patients with malignancy or metastatic disease, pregnant females and patients unwilling to be included in the study Treatment - Other Treatment - Other Control group: Spinal anesthesia was administered in Group S using a standard 27 G Braun spinal needle in the L3-L4 spinal space under strict aseptic measures by a consultant anesthetist and 0.5% hyperbaric bupivacaine using a volume of 2.5 ml was administered. Onset and quality of sensory and motor block was checked and re-assessed every 2 minutes using the modified Bromage scale for motor and cold spray method for check for sensory block integrity until an effective sensory level was achieved for spinal dermatomal level T12 and below and motor block effectiveness with a Bromage score of 1. Control group: Patient in the femoropopliteal block group were administered the block in prone position for the popliteal block blocking the tibial and common peroneal nerves in the popliteal space using 15ml of 0.5%bupivacaine with 2mg dexamethasone. Patients were then turned supine and 5ml of 0.5%bupivacaine with 0.5mg dexamethasone was administered in the femoral sheath for the femoral block. Both the blocks were performed under strict aseptic measures by a consultant pain specialist following standard guidelines furnished by NYSORA. Onset of the block was checked and re-assessed every two minutes until sensory and motor blocks were achieved as in the spinal group. We conclude that spinal anesthesia provides early sensory and motor onset but femoropopliteal block is superior when comparing block duration and total dose of analgesia needed in 24 hours post-operatively. Timepoint: 24 hours post operative. Method of measurement: By measuring the logevity of the block. Combined military hospital Approved 2023-08-01 Ethical comiittee of combined military hospital Tamizudin road , lalkurti rawalpindi Rawalpindi punjab Pakistan