Clinical trial NCT06076018: The Contribution of Intrathecal Morphine Administration to Postoperative Patient Satisfaction During Cesarean Delivery
Official title: The Contribution of Intrathecal Morphine Administration to Postoperative Patient Satisfaction During Cesarean Delivery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cesarean Section
Intrathecal Morphine
Quality of Recovery 40
Keywords: Quality of Recovery 40
intrathecal morphine
cesarean section
Lead sponsor: Ondokuz Mayıs University
Sponsor class: OTHER
First posted: 2023-10-10
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: All patients, whose consent was obtained, were monitored for standard noninvasive blood pressure, heart rate (HR), electrocardiogram (ECG) findings, and peripheral oxygen saturation (SpO2) in the operating room.

Patients were evaluated for side effects such as pain, nausea-vomiting, itching, sedation score, and respiratory depression (defined as respiratory rate \<10/min or SpO2\<93%) for 24 hours postoperatively. Evaluations were made at the 2nd, 4th, 6th, 8th, 12th and 24th hours postoperatively. Pain assessment was made with the 'Numeric Rating Scale' (NRS) (0-10, 0 = no pain and 10 = worst pain imaginable), sedation assessment was made with the 'Ramsey Sedation Scale'. Nausea was evaluated as present or absent (0:absent, 1:present) and itching 'Verbal Descriptive Scale' (0: no itching, 1: was evaluated using mild, 2: moderate, 3: severe, 4: very severe).

At the 24th postoperative hour, all patients were visited in the ward and the QoR-40 (Quality of Recovery-40) patient satisfaction compilation quality scale, scored between 40-200, was filled out. The QoR-40 questionnaire is a self-rating questionnaire used to evaluate the quality of postoperative recovery and health status of patients in the early postoperative stages. For the first time, Myles et al. () in 2000 and was proven to be a valid test in Turkey by Karaman S. et al. in 2014. QoR-40 was used to evaluate the pain levels, physical and emotional status of patients; emotional state (n = 9), comfort ( It consists of five sections and 40 questions: n = 12), patient support (n = 7), physical independence (n = 5), and pain (n = 7). Each question is scored on a five-point Likert scale ranging from 1 to 5. The total score ranges from 40 (worst build quality) to 200 (best build quality).

This widely used survey has been successfully applied to populations with cultural and physical differences in many different countries. QoR-40 studies conducted after a wide variety of anesthesia and surgical techniques reveal how wide the field of use of the test is. As a result of all this, the researchers reported that the test was safe and applicable.

Maternal characteristics such as age, weight, height, gestational age, gravidity, parity, number of previous cesarean births and procedure time, and tubal ligation were recorded. Newborn characteristics were collected, including weight and Apgar scores

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

Primary outcomes:
measure: Difference in QoR-40 score at 24th postoperative hour
timeFrame: Postoperative Day 1
Secondary outcomes:
measure: Post-operative acute pain
timeFrame: Postoperative Day 1
Other outcomes:
Locations:
city: Samsun
country: Turkey
facility: Ondokuz Mayıs University Faculty of Medicine
Study officials:
References:
citation: Dahl JB, Jeppesen IS, Jorgensen H, Wetterslev J, Moiniche S. Intraoperative and postoperative analgesic efficacy and adverse effects of intrathecal opioids in patients undergoing cesarean section with spinal anesthesia: a qualitative and quantitative systematic review of randomized controlled trials. Anesthesiology. 1999 Dec;91(6):1919-27. doi: 10.1097/00000542-199912000-00045. No abstract available.
citation: Palmer CM, Emerson S, Volgoropolous D, Alves D. Dose-response relationship of intrathecal morphine for postcesarean analgesia. Anesthesiology. 1999 Feb;90(2):437-44. doi: 10.1097/00000542-199902000-00018.
citation: Myles PS, Weitkamp B, Jones K, Melick J, Hensen S. Validity and reliability of a postoperative quality of recovery score: the QoR-40. Br J Anaesth. 2000 Jan;84(1):11-5. doi: 10.1093/oxfordjournals.bja.a013366.
citation: Karaman S, Arici S, Dogru S, Karaman T, Tapar H, Kaya Z, Suren M, Gurler Balta M. Validation of the Turkish version of the Quality of Recovery-40 questionnaire. Health Qual Life Outcomes. 2014 Jan 15;12:8. doi: 10.1186/1477-7525-12-8.