Comparison of pain intensity and intrathecal complications of 50 and 100 μg morphine with very low dose of naloxone in patients undergoing cesarean section

Comparison of pain intensity and intrathecal complications of 50 (group 50) and 100 (group 100) micrograms of morphine with very low dose of naloxone in patients undergoing cesarean section

Clinical trial without control group with parallel parallel randomized bilateral groups of phase 2 on 94 patients with Sequentially numbered, sealed, opaque envelopes method

Location of Imam Khomeini Hospital, Sari, 13. Patients in group 1 will receive 50 micrograms of intrathecal morphine with bupivacaine and in group 2, 100 micrograms of intrathecal morphine with bupivacaine. And assessors and assistants who visit the patient and complete the questionnaire every 6 hours 24 hours after surgery are kept blind.

Introduction: Informed consent to participate in the study • Age over 18 years • Pregnant women with prior planning for cesarean section without major comorbid disease ) • First or second pregnancy • Willingness to give birth by cesarean section under spinal anesthesia Exclusion criteria: Dissatisfaction to participate in the study • Any contraindications to anesthesia with spinal technique • History of any allergy or idiocyncratic reaction to opioid drugs • Pain syndrome Chronic or regular use of opioids • Predictable evidence of fetal abnormality • Allergy or intolerance to ketorolac, ibuprofen or oxycodone • Body mass index above 40 • Failure of spinal anesthesia • Prolonged operation time

Patients in group 1 will receive 50 micrograms of intrathecal morphine with bupivacaine and in group 2, 100 micrograms of intrathecal morphine with bupivacaine.

Reduce pain intensity

Block randomization In this method, a random sequence is first created using Snose software, Random Allocation version 2 software will be used for random arrangement of samples in blocks. In this software, we set the number of groups to 2, the number of samples to 47, the size of the blocks to be equal, and the coding to be a combination of letters, numbers, and random. Then, based on the sample size, read a number of envelopes with wrappers Aluminum (in order to obscure the contents of the envelopes), is prepared and each of the random sequences created is recorded on a card and the cards are placed inside the envelopes in order. In order to maintain a random sequence, the envelopes are numbered in the same way on the outer surface. (Example: TF8G written on the envelope and the card inside the intervention envelope). Finally, the lids of the envelopes are glued and placed inside a box, respectively. At the beginning of the registration of participants, according to the order of entry of eligible participants to the study, one of the envelopes of the letter is opened and the assigned group of the participant is revealed.

The SNOSE method is used to hide (blind) random allocation. This method is one of the common methods in concealing random allocation. The researcher, assistant and anesthesiologist who is given a sample to inject, evaluate and analyze the data are kept blind in the study.