Patients' Satisfaction for Pain Control Modalities After Caesarean Section Using Erector Spinae Plain Block Vs Lateral Quadratus Lumborum Block. a Randomized Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 126
- Locations
- 1
- Primary Endpoint
- To test whether the type of the plane block have an implication on the patients' satisfaction.
Study Overview
Brief Summary
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
Detailed Description
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.
-
AIM/OBJECTIVES To study 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 assess whether the type of the plane block has an implication on the patients' satisfaction. The secondry outcome is to assess the difference between the two approaches on the hospital discharge.
-
METHODOLOGY: Patients and Methods, Subjects and Methods, Material and Methods • Type of Study: Randomized clinical trial Study Setting: Obstetric and gynecological hospital, Faculty of medicine, Ain Shams university. • Study Period: 6 months • Study Population: Inclusion Criteria: • Parturient female • Scheduled for elective caesarean section Exclusion Criteria: • Known allergy to any of the medication used • Patients refused to participate in the study • Patients with emergency section • Patients with Bleeding disease • Patients with postpartum hemorrhage
• Sampling Method: The patients will be randomly divided into two equal groups; randomization will be done by computer-generated number lists. ALL the patients will receive spinal anesthesia after proper sterilization of the back with betadine, 2.5 ml of heavy Bupivacaine 0.5%, together with twenty-five micrograms of fentanyl at the level of L 4-5. The block was maintained at level T4. The patients will be divided into two groups: Group E includes sixty-three women; those will receive an ultrasound-guided low thoracic Erector spinae plane block at level of T9 with a total volume of 60 ml of bupivacaine 0.3% and Dexmedetomidine at a total dose of 0.5 micrograms/kg [8].
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Triple (Participant, Care Provider, Outcomes Assessor)
Masking Description
The patient will be blind to the technique he will receive, and the care giver will be unaware of the block the patient being cared for received. Furthermore, the outcomes assessor, who is in charge of collecting the data, has no idea who received which block.
Eligibility Criteria
- Ages
- — to 40 Years (Child, Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Parturient female
- •Scheduled for elective cesarean section
Exclusion Criteria
- •Known allergy to any of the medications used
- •Patients refused to participate in the study
- •Patients with emergency section,
- •Patients with Bleeding disease
- •Patients with postpartum haemorrhage
Arms & Interventions
Bilateral Ultrasound-Guided Erector Spinae Plane Block (group E)
those will receive Bilateral ultrasound-guided low thoracic Erector spinae plane block at a level of T9 with a total volume of 60 ml of bupivacaine 0.3% and Dexmedetomidine at a total dose of 0.5 mcg/kg
Intervention: Bilateral Ultrasound-Guided Erector Spinae Plane Block (group E) (Procedure)
Bilateral Ultrasound-guided Quadratus Lumborum, Lateral approach (group Q)
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 mcg/kg.
Intervention: Bilateral Ultrasound-guided Quadratus Lumborum, Lateral approach (group Q) (Procedure)
Outcomes
Primary Outcomes
To test whether the type of the plane block have an implication on the patients' satisfaction.
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.
Secondary Outcomes
- to test the difference between the two approaches on the hospital discharge(24-48 hours after the surgery)
Investigators
Wael Sayed El Gharabawy
assisstant professor of Anesthesia, Intensive care, and Pain management
Ain Shams University
