Clinical trial

The Contribution of Intrathecal Morphine Administration to Postoperative Patient Satisfaction During Cesarean Delivery

Name

drilketamdogan

Description

Evaluating the contribution of intrathecal morphine administration to postoperative patient satisfaction during cesarean delivery with the QoR-40 (Quality of Recovery 40) patient satisfaction compilation quality scale, scored between 40-200, and demonstrating the difference in the global QoR-40 score.

Trial arms

Trial start

2023-11-20

Estimated PCD

2024-03-01

Trial end

2024-04-30

Status

Completed

Treatment

Group morphine

Spinal anesthesia will be applied to patients in a sitting position, with a midline approach, after aseptic conditions have been achieved. A 25 gauge pencil point spinal needle will be placed in the L3-4 or L4-5 space. Upon aspiration of clear cerebrospinal fluid (CSF), 12 mg hyperbaric bupivacaine and 20 mcg fentanyl will be administered intrathecally, and 120 mcg intrathecal morphine (ITM) will be administered to the morphine group. the 24th postoperative hour, all patients will be visited in the ward and the QoR-40 (Quality of Recovery-40) patient satisfaction recovery quality scale, scored between 40-200, will be filled out.

Arms:

intrathecal morphine

Other names:

intrathecal morphine

Group placebo

Spinal anesthesia will be applied to patients in a sitting position, with a midline approach, after aseptic conditions have been achieved. A 25 gauge pencil point spinal needle will be placed in the L3-4 or L4-5 space. Upon aspiration of clear cerebrospinal fluid (CSF), 12 mg hyperbaric bupivacaine and 20 mcg fentanyl will be administered intrathecally. the 24th postoperative hour, all patients will be visited in the ward and the QoR-40 (Quality of Recovery-40) patient satisfaction recovery quality scale, scored between 40-200, will be filled out.

Arms:

intrathecal fentanyl

Other names:

control

Size

Primary endpoint

Difference in QoR-40 score at 24th postoperative hour

Postoperative Day 1

Eligibility criteria

Inclusion Criteria: * Between 18-40 years old, * ASA physical status 2 * Patients who will give birth by elective cesarean section Exclusion Criteria: * Those who do not accept regional anesthesia, * Pregnant women who have problems where spinal anesthesia is contraindicated, such as infection at the injection site, coagulopathy, bleeding diathesis, severe hypovolemia, increase in intracranial pressure, severe aortic stenosis, severe mitral stenosis, * Patients with a history of allergy to any drug included in the study protocol

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'In the study planned as a randomized clinical study, patients who use and do not use intrathecal morphine will be assigned to 2 groups, 30 people in each group, by the sealed envelope method. Patients, surgeons, and physicians who will perform postoperative evaluation and fill out the questionnaire will be blinded to the randomization of the groups.', 'primaryPurpose': 'SUPPORTIVE_CARE', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 60, 'type': 'ACTUAL'}}

Updated at

2024-05-17

1 organization

1 product

3 indications

Organization

Ondokuz Mayıs University

Product

Morphine

Indication

c-section

Indication

Morphine

Indication

Quality of Recovery 40