Ondokuz Mayıs University
Samsun, Turkey (Türkiye)
NCT Number: NCT06481462
In this study, it was aimed to evaluate the effects of intrathecal morphine and posterior quadratus lumborum block (QLB2) on postoperative acute pain scores and opioid consumption in the first 24 hours after cesarean section.
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Notify Me18 year–45 year
Female
Observational
Samsun, Turkey (Türkiye)
Postoperative acute pain following a cesarean section is sharp, well-localized, and highly intense. An ideal pain management approach after a cesarean section should provide high-quality analgesia with minimal side effects and facilitate the mother's rapid return to daily activities. Different options for pain control include central blocks, peripheral blocks, and systemic medications.
Intrathecal morphine (ITM) administration is a widely used approach for post-cesarean pain management both globally and in our clinic. However, it can reduce patient satisfaction due to side effects such as nausea, vomiting, and itching. On the other hand, the Quadratus Lumborum Block (QLB), a type of peripheral block, has proven analgesic efficacy in controlling acute postoperative pain following a cesarean section. The aim of this study is to examine and compare the analgesic efficacy of intrathecal morphine (ITM) and Posterior Quadratus Lumborum in the management of acute postoperative pain after a cesarean section.
This study is a single-center, double-blind, prospective observational study.
Patients will be divided into 2 groups.
Group 1: The group receiving intrathecal morphine (ITM)
Group 2: The group receiving Posterior Quadratus Lumborum Block
In elective cesarean section cases under spinal anesthesia, the patient group receiving ITM and posterior QLB will be evaluated for obstetric general well-being during the first 24 hours and at discharge. Total morphine consumption in the first 24 hours, Pain scores (NRS) at rest and during movement, presence of nausea-vomiting and itching, patient satisfaction and any potential side effects will be recorded through follow-up.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
morphine 100 mcg + 12.5 mg bupivacaine + 20 mcg fentanyl
12.5 mg bupivacaine + 20 mcg fentanyl bilateral QLB block (posterior tip 2) 25 cc 0.25% bupivacaine
Time frame: Postoperative day 1
Morphine consumption in the first 24 hours will be measured by IV PCA. Patients will be able to request opioids via a PCA device when their NRS score is above 4
Time frame: Postoperative day 1
Pain status at rest and while coughing will be assessed by NRS scores at 0, 3, 6, 12, and 24 hours after operation.The NRS is an 11-point numeric scale which ranges from 0 to 10.
Time frame: Postoperative Day 1
The severity of postoperative nausea and vomiting (PONV) will be assessed using a descriptive verbal rating scale at 0, 3, 6, 12, 18, and 24 hours after extubation. If a score of 3 or more, ondansetron 4 mg IV will be administered and will repeat after 8 hours if required. The PONV scale is 0 = no nausea; 1 = slight nausea; 2 = moderate nausea; 3 = vomiting once; and 4 = vomiting more than once.
Time frame: Postoperative Day 1
The number of patient requires rescue analgesic will be recorded at 0, 3, 6, 18, and 24 hours after operation
Time frame: Postoperative Day 1
Pruritus score: 0 = no pruritus; 1 = sensation of itching, but not scratching, just a rubbing sensation (mild); 2 = sensation of itching and scratching (moderate); 3 = sensation of pruritus, scratching, and requiring treatment (severe).
Time frame: Postoperative Day 1
Patients' pain management satisfaction and quality will be evaluated using the QoR-11 score. ObsQoR-11 is an 11-item questionnaire that is used to evaluate the recovery of parturient women after elective CS. ObsQoR-11 is evaluated in terms of the degree of post-operative pain, nausea, vomiting, activity, baby care, hygiene,and emotional control. Each item was scored using an 11-point system, with minimum and maximum scores of 0 and 110, respectively. A high score reflects good recovery.
QoR-11 Turkish Version will be used for assessment.
Ondokuz Mayıs University
Other
Comparison of the Effects of Intrathecal Morphine and Ultrasound-Guided Bilateral Posterior Quadratus Lumborum Block on Postoperative Acute Pain in Cesarean Section: A Prospective, Observational Study
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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