Comparative study between the analgesic effect of ketorolac when administrated intra-venous preoperatively versus when added to local anesthesia in squint surgery

To evaluate safety and efficacy of ketorolac regarding its analgesic effect as an adjuvant for peribulbar block in squint surgery, and whether it is better if administrated intravenously preoperatively or when combined with the local anesthetics.

Parallel group, randomized, controlled clinical trial with 1:1:1 allocation ratio.

Research Institute of Ophthalmology, Giza, Egypt.

We will include adult (30-70 years-old) male or female patients, indicated for squint surgery who are ASA I, II, or III. We will exclude patients with any of the following conditions: coagulopathy or on anticoagulant drugs, infection at the site of the surgery, posterior staphyloma, allergy to any of the used drugs, and bronchial asthma or bradyarrhythmia.

The trial has three groups. The control group will include 30 patients, each will receive lidocaine 2% (10 ml) + hyaluronidase (5 IU per ml). The intervention group 1 will include 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)]. The intervention group 2 will include 30 patients, each will receive lidocaine 2% (10 ml) with hyaluronidase (5 IU per ml) plus ketorolac (4 mg per ml).

The primary outcome variables include the onset of sensory and motor blocks, the duration of the block, postoperative pain using VAS, and the time to first dose of analgesic. The secondary outcomes include hemodynamics (heart rate, blood pressure, oxygen saturation), patient's and surgeon's satisfaction, and adverse effects.

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.

Participants and outcome assessors will be blinded to the type of intervention.

Ketorolac in peribulbar block for squint surgery IPD set (all collected deidentified IPD).

Beginning 6 months and ending 36 months following article publication.

Researchers from academic institutions whose proposal for the use of data has been approved by an independent review committee identified for this purpose.

For IPD meta-analysis.

From the PI.

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.