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IRCT20210106049952N2 IRCT 2021-11-14 Research Institute of Ophthalmology Comparative study between the analgesic effect of ketorolac when administrated intra-venous preoperatively versus when added to local anesthesia in squint surgery Comparative study between the analgesic effect of ketorolac when administrated intra-venous preoperatively versus when added to local anesthesia in squint surgery 2021-11-15 anticipated 90 Complete https://irct.ir/trial/59813 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: We used the sealed, opaque sequentially numbered envelopes method for randomization and allocation concealment of patients included in this trial. We used 90 identical, opaque, letter-sized envelopes. We used rolls of household aluminum cooking foil that we cut into 90 sheets (of the same width as and twice the height of the envelope). We prepared 90 envelope-sized sheets of white paper and 90 envelope-sized sheets of single sided carbon paper. We wrote “Treatment A” on 30 paper sheets, “Treatment B” on another 30 sheets, and “Treatment C” on the last 30 sheet. To prepare 30 “Treatment A” envelops, we selected one envelope-sized sheet of of Treatment A and placed one sheet of carbon paper on top of the Treatment A allocation paper with the carbon side facing the paper, then we put both papers inside a foil wrapper. Then, the completed insert was placed into a blank envelope with the carbon paper closest to the front of the envelope. Finally, the envelop was sealed and we signed across the seal. We completed all the 30 “Treatment A” envelops the same way. We prepared 30 “Treatment B” envelops and 30 “Treatment C” envelops the same way as “Treatment A” envelops. The three sets of envelops were combined and we shuffled them thoroughly. Then, using a pen we marked a number on the front of each envelope sequentially from 1 to 90. The carbon paper inside the envelope will transfer this number to the allocation paper inside. Finally, we placed these envelopes into a plastic container, in numerical order, ready for use, Blinding description: Participants and outcome assessors will be blinded to the type of intervention. 2 Peribulbar block in adult patients undergoing squint surgery. Intervention 1: Control group: Includes 30 patients. Each will receive lidocaine 2% (10 ml) with hyaluronidase (5 IU per ml). Intervention 2: Intervention group 1: Includes 30 patients. Each will receive 30 mg of ketorolac half an hour before the surgery and the local anesthesia [lidocaine 2% (10 ml) with hyaluronidase (5 IU per ml)]. Intervention 3: Intervention group 2: Includes 30 patients. Each will receive lidocaine 2% (10 ml) with hyaluronidase (5 IU per ml) plus ketorolac (4 mg per ml). Yes - There is a plan to make this available What will be shared: Ketorolac in peribulbar block for squint surgery IPD set (all collected deidentified IPD). When: Beginning 6 months and ending 36 months following article publication. To whom: Researchers from academic institutions whose proposal for the use of data has been approved by an independent review committee identified for this purpose. Conditions: For IPD meta-analysis. Where to obtain: From the PI. How to obtain: A proposal for the use of data to be submitted to the PI to be evaluated by an independent review committee identified for this purpose. Comments:
public Dr. Iman Sobhy
2 El Ahram Street
Giza Egypt 12557 +20 2 35718304 iman.sobhy333@gmail.com Research Institute of Ophthalmology scientific Iman Sobhy
2 El Ahram Street
Giza Egypt 12557 +20 2 35735688 iman.sobhy333@gmail.com Research Institute of Ophthalmology Egypt Squint surgery American Society of Anesthesiologists Physical Status I, II, or III 30 to 70 years-old 30 years 70 years Both American Society of Anesthesiologists Physical Status IV Coagulopathy or use of anticoagulant therapy Infection at the site of the block Posterior staphyloma Allergy to the local anesthetic agent used Bronchial asthma or bradyarrhythmia Uncooperative patient or refusal to participate in the study Other Other Other Control group: Includes 30 patients. Each will receive lidocaine 2% (10 ml) with hyaluronidase (5 IU per ml). Intervention group 1: Includes 30 patients. Each will receive 30 mg of ketorolac half an hour before the surgery and the local anesthesia [lidocaine 2% (10 ml) with hyaluronidase (5 IU per ml)]. Intervention group 2: Includes 30 patients. Each will receive lidocaine 2% (10 ml) with hyaluronidase (5 IU per ml) plus ketorolac (4 mg per ml). Onset of sensory block. Timepoint: Every 5 seconds after the block till complete loss of sensation. Method of measurement: Clinical assessment using gentle touching of the cornea with cotton swab. Onset of motor block. Timepoint: Every 5 seconds after the block till complete loss of eye movement. Method of measurement: Clinical assessment using the 3-point score in four directions; where 0=no movement, 1=partial movement, and 2=complete movement (with total of 10). Duration of the block. Timepoint: Every 10 minutes following the block till full recovery of the movement. Method of measurement: Clinical assessment. Postoperative pain. Timepoint: Immediately after the surgery, and 1 h, 2 h, 4 h, and 6 h later. Method of measurement: Visual analog scale (from 0 to 10; where 0=no pain and 10=severe pain). Time to the first analgesic dose. Timepoint: Immediately after the surgery and every 30 minutes. Method of measurement: Clinical assessment. Hemodynamics (heart rate, blood pressure, and oxygen saturation). Timepoint: Baseline, immediately after the block, and every 10 min after the block. Method of measurement: Electronic vital signs monitor. Patient satisfaction. Timepoint: At the end of the surgery. Method of measurement: Questioning and scoring (1=no pain felt, 2=no comment, 3=moderate discomfort, 4=severe pain). Surgeon satisfaction. Timepoint: At the end of the surgery. Method of measurement: Questioning and scoring (0=unsuccessful, 1=poor, 2=acceptable, 3=perfect). Adverse effects, such as pain on injection, allergy to the drugs used, or bronchospasm. Timepoint: Following the block. Method of measurement: Clinical assessment. Self-funded Approved 2021-01-03 Ethical Committee of the Research Institute of Ophthalmology 2 El Ahram Street Giza Cairo Egypt