Comparing the effect of epidural catheter with ketamine drip in analgesia after elective thoracotomies

In this study, the level of analgesia of epidural catheter and ketamine drip after thoracotomy was compared, and the effect of these two methods of analgesia on blood pressure, heart rate, and respiratory rate was also examined.

A phase 2 randomized, single-blind, parallel-group, controlled clinical trial is being conducted on 72 patients.

In this single-blind clinical trial, all patients who are candidates for elective thoracotomy surgery at Sina Hospital in Tehran will be included in the study.

Inclusion criteria; Age between 18 and 70 years, Indications for Thoracotomy Exclusion criteria; Death before thoracotomy, Patients with known coagulation disorders, Uncontrolled diabetes, History of addiction, Allergy to ketamine, History of psychiatry diseases, History of seizures.

In Intervention group, after induction of anesthesia before the first incision, 0.3 mg/kg intravenous ketamine is administered as a bolus, followed by intravenous infusion at a rate of 0.3 mg/kg/hour for patients. In case of postoperative pain (VAS score > 4), 2.5 mg of intravenous morphine is injected and its frequency is recorded. In Control group, at the end of the operation, epidural infusion of 0.2% ropivacaine is started in all patients at an infusion rate of 10 cc/hour. In case of postoperative pain (VAS score > 4), 2.5 mg of intravenous morphine is injected and its frequency is recorded.

The postthoracotomy pain

Randomization will be performed using the random permutation block method. In this method, the block sizes are 4 and 2 (in random order) and the allocation ratio is 1:1. In this way, an equal number of each treatment will be provided in each block. The random sequence will be generated by the methodologist using the sealedenvelope.com software. The random allocation list of the clusters will be available only to the design methodologist. In order to conceal the randomization process, 72 paper labels will be written with random 10-digit codes without a specific order and frame, which will be the identification number of the relevant treatment, and only the design methodologist will be aware of the relevant code. The labels will be attached to the drug packages in the order of the randomization list. The drug packages will be arranged in a box in the order of the randomization list. When the physician declares a patient eligible, the design methodologist will provide the patient with the treatment package. The design methodologist will be excluded from the rest of the study processes.

The study is single-blind. The drugs used in the two groups are prepared in identical containers without name labels, in the same color and smell, and are coded. They are provided to both groups based on random allocation by the project partner, so none of the patients are aware of the treatment assigned and will not be informed until the end of the study.

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