Ain Shams University Hospitals
Cairo, Egypt, 11728
Location contact
Alaa eldin M zorkany, professor
CONTACT
wael S Algharabawy, MD
CONTACT
NCT Number: NCT06771466
The study will compare the difference between the patient's satisfaction after Erector spinae plane block (ESP) and Quadratus Lumborum block lateral approach after caesarean section alone or as part of multimodal analgesia.
The primary outcome is to test whether the type of plane block has an implication on the patients' satisfaction.
The secondary outcome is to test the difference between the two approaches on the hospital discharge
Trial opening soon.
Get NotifiedUp to 40 year
Female
Interventional
Not applicable
Cairo, Egypt, 11728
Alaa eldin M zorkany, professor
CONTACT
wael S Algharabawy, MD
CONTACT
The study will compare the difference between the patient's satisfaction after Erector spinae plane block (ESP) and Quadratus Lumborum block lateral approach after caesarean section alone or as part of multimodal analgesia. The primary outcome is to evaluate whether the type of plane block has an implication on the patients' satisfaction. The secondary outcome is to evaluate the difference between the two approaches on the hospital discharge.
Detailed Description IT is well Known that both Erector spinae plane block (ESP) and quadratus lumborum block are good modality for postoperative pain control after abdominal surgeries, this study will assess which one of both modalities is superior in achieving the patient's satisfaction after caesarean section. 1. INTRODUCTION: The goals for effective post-caesarean analgesia are interrelated and include allowing maternal bonding with her neonate, facilitating postoperative mobilization to reduce the risk of thromboembolism, preserving the ability for the mother to care for her infant, minimizing opioid use, and allowing safe breastfeeding with minimal transfer of analgesics to the neonate [1]. The options for post-caesarean delivery pain control include acetaminophen, non-steroidal anti-inflammatory drugs, intravenous opioids, fascial plane blocks, and neuro-axial opioids [1, 2]. Efforts to reduce the doses of opioids prescribed after CD, both in the hospital and after discharge, are increasing. The lowest effective dose of any opioid should be used to minimize breast milk transfer and associated neonatal sedation. Neuraxial opioids are preferred to other routes of administration, when possible, to minimize maternal blood and breast milk levels [3]. If opioids are required, breastfeeding should ideally start just prior to opioid administration, as the drug concentration in breast milk rises and falls in parallel with maternal plasma levels [3]. Highly protein-bound medications such as nonsteroidal anti-inflammatory drugs (NSAIDs) and local anesthetics transfer less readily into breast milk than opioids and other lipophilic drugs [4]. A reported advantage of QL blocks is the possibility of providing better visceral analgesia compared with TAP blocks. However, the literature on the relative benefits of QL versus TAP blocks and other blocks for post-CD analgesia is conflicting. However, QL blocks can result in lower extremity weakness, particularly for the variants that involve more central injection of LA as in anterior QL [5]. Available literature regarding the use of other nerve blocks (e.g., ESP, ilio-inguinal ilio-hypogastric [IIH], transversalis fascia plane, QL blocks) has been described but is limited regarding the analgesic effect, duration of action, quality of recovery and the relation to each other. [6,7]. It is well known that dermatomal coverage from ESP blocks depends on the volume and dose of local anesthetic administered. Blocks placed at low thoracic levels (e.g., T9 to 10) should provide appropriate coverage for low transverse incision for CD.
Group Q: Includes 63 women. Those patients will receive bilateral ultrasound-guided quadratus lumborum, lateral approach with a total volume of 60 ml of bupivacaine 0.3% and dexmedetomidine at a total dose of 0.5 mg/kg.
All patients will be monitored at 2 hrs. postpartum and every 6 hrs. for 24 hours, and the following will be recorded: The need for adjuvant analgesics, the first time to ask for adjuvants, the beginning of the mother-baby bond, the ambulation of the patients, the pain score using a numerical analogue scale, the type of pain, if there is a change in SBP > 20 mmHg or HR > 20/min, an increase in RR > 10 above baseline or a 5% decrease in SaO2, and the time for discharge. The patient's satisfaction to the block will be measured using 4 points Likert assessment to the question, "Are you satisfied with the pain management done after the caesarean section?" totally disagree, disagree, Agree, totally agree. In case the patient feels pain after the block, it will be managed in a stepwise manner, and each step will be recorded by ketorolac (30 mg prn every 8 hr) and recorded. Paracetamol 1gm prn every 6hr and will be recorded. Morphine 4 mg incremental dose up to achieving the target level with a maximum dose 0.1 mg/kg/dose prn every 6 hrs. and will be recorded. The patient with failed block will be recorded and managed by the aforementioned steps, and the investigators will consider repeating the block. Failure of the block means that the patient is feeling severe agonizing pain that interferes with her physical and social activities, such as taking a normal breath, starting breastfeeding, starting movement, and so on.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The curvilinear ultrasound transducer should be placed in a cephalocaudal orientation over the midline of the back at the desired level. The probe should then slowly be moved laterally until the transverse process is visible. The transverse process requires differentiation from the rib at that level. The transverse process will be more superficial and wider, while the rib will be deeper and thinner. Upon verification of the transverse process, the trapezius muscle, rhomboid major muscle (if performing at T5 level or higher), and erector spinae muscle should be identified superficial to the transverse process. The Tuohy needle should be inserted superior to the ultrasound probe using an in-plane approach in the cephalad to caudal direction.
With the patient positioned in the lateral position, scanning is usually started at the mid-axillary line between the iliac crest and subcostal margin, moving the probe posteriorly until tapering of the three abdominal muscle layers and appearance of fascia transversalis and QL muscle are observed. The fascia transversalis usually appears as a hyperechoic layer, which forms a safe landmark to separate the muscle layers from the peri-nephric fat and the abdominal contents
Time frame: first 24 hours after the surgery
The patient's satisfaction with the block will be measured using a 4-point Likert assessment to the question, "Are you satisfied with the pain management done after the cesarean section?" totally disagree, disagree, agree, totally agree.
Time frame: 24-48 hours after the surgery
report the time for discharge from the hospital after the surgery and if there is any delay or complications after the procedure
Contact information is provided by the study sponsor or research team.
wael S algharabawy, MD
CONTACT
waleed Y youssef, MD
CONTACT
Wael Sayed El Gharabawy
Other
Patients' Satisfaction for Pain Control Modalities After Caesarean Section Using Erector Spinae Plain Block Vs Lateral Quadratus Lumborum Block. a Randomized Clinical Trial
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