SatisfactionNCT06771466
Post-c-section Pain Control Satisfaction with Erector Spinae Simple Block Vs Lateral Quadratus Lumborum Block
A study testing Bilateral Ultrasound-Guided Erector Spinae Plane Block (group E) and Bilateral Ultrasound-guided Quadratus Lumborum, Lateral approach (group Q) in people with Satisfaction and Pain Management After Surgery, run by Wael Sayed El Gharabawy at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 40 years, women only
- Conditions the study is for
- Satisfaction, Pain Management After Surgery
- What is being tested?
- Bilateral Ultrasound-Guided Erector Spinae Plane Block (group E) and Bilateral Ultrasound-guided Quadratus Lumborum, Lateral approach (group Q)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 126 participants
- Where
- 1 siteEgypt
- Study dates
- Mar 2025to Oct 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 40 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Parturient female
- Scheduled for elective cesarean section
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Ain Shams University Hospitals
Cairo, Egypt, 11728
Alaa eldin M zorkany, professor, 00201115811666, alaa.zorkany@med.asu.edu.eg
wael S Algharabawy, MD
About this study
Official title: Patients' Satisfaction for Pain Control Modalities After Caesarean Section Using Erector Spinae Plain Block Vs Lateral Quadratus Lumborum Block. a Randomized Clinical Trial
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
Read the 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].
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.
- Sample Size: Sample size was calculated using PASS II software. setting the type-1 error (α) at 0.05 , power (1-β) at 0.8 and confidence width level at 0.1 , Calculation according to the values of previous studies' Comparative efficacy of quadratus lumborum type II and erector spinae plane block in patients undergoing caesarean section under spinal anesthesia: a randomized controlled trial produced a sample size of at least 63 cases for each group.
- Ethical Considerations: The study will be conducted after approval by the Research Ethics Committee of the Faculty of Medicine, Ain Shams University, and conducted in accordance with the principles of the Declaration of Helsinki. A written informed consent before enrolment will be taken.
- Study Procedures:
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.
- Statistical analysis All statistical procedures will be conducted using SPSS version 20 for Windows (SPSS Inc, Chicago, IL, USA).
- Conditions
- Satisfaction, Pain Management After Surgery
- Being tested
- Bilateral Ultrasound-Guided Erector Spinae Plane Block (group E), Bilateral Ultrasound-guided Quadratus Lumborum, Lateral approach (group Q)
- Keywords
- nerve block, pain, opioids, patient satisfaction, cesarean section
- Medical subject headings
- Personal Satisfaction, Pain, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bilateral Ultrasound-Guided Erector Spinae Plane Block (group E)Procedure or surgery
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.
Bilateral Ultrasound-guided Quadratus Lumborum, Lateral approach (group Q)Procedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| Bilateral Ultrasound-Guided Erector Spinae Plane Block (group E) | Active comparator | 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 Receives: Procedure: Bilateral Ultrasound-Guided Erector Spinae Plane Block (group E) |
| Bilateral Ultrasound-guided Quadratus Lumborum, Lateral approach (group Q) | Sham comparator | 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. Receives: Procedure: Bilateral Ultrasound-guided Quadratus Lumborum, Lateral approach (group Q) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To test whether the type of the plane block have an implication on the patients' satisfaction.
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.
Measured: first 24 hours after the surgery
Secondary outcomes (1)
to test the difference between the two approaches on the hospital discharge
report the time for discharge from the hospital after the surgery and if there is any delay or complications after the procedure
Measured: 24-48 hours after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2025
- Study startMar 2025 (estimated)
- Primary completionSep 2025 (estimated)
- Study completionOct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for SatisfactionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- To investigate the difference in patient satisfaction following Erector spinae plane block (ESP) and Quadratus Lumborum block lateral approach after caesarean surgery, either alone or as part of multimodal analgesia.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 126 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wael Sayed El Gharabawy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Wael Sayed El Gharabawy, Ain Shams University
- Investigators
- Wael S El Gharabawy, MD, Principal investigator, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06771466
- Sponsor's protocol ID
- FMASU R254/2024
- Status last verified
- Jan 2025
- First submitted
- 27 Dec 2024
- Last updated
- 13 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ong CK, Seymour RA, Lirk P, Merry AF. Combining paracetamol (acetaminophen) with nonsteroidal antiinflammatory drugs: a qualitative systematic review of analgesic efficacy for acute postoperative pain. Anesth Analg. 2010 Apr 1;110(4):1170-9. doi: 10.1213/ANE.0b013e3181cf9281. Epub 2010 Feb 8.
PubMed 20142348Sutton CD, Carvalho B. Optimal Pain Management After Cesarean Delivery. Anesthesiol Clin. 2017 Mar;35(1):107-124. doi: 10.1016/j.anclin.2016.09.010. Epub 2016 Dec 12.
PubMed 28131114Wikner M. Unexpected motor weakness following quadratus lumborum block for gynaecological laparoscopy. Anaesthesia. 2017 Feb;72(2):230-232. doi: 10.1111/anae.13754. Epub 2016 Nov 28.
PubMed 27891579Ribeiro Junior IDV, Carvalho VH, Brito LGO. Erector spinae plane block for analgesia after cesarean delivery: a systematic review with meta-analysis. Braz J Anesthesiol. 2022 Jul-Aug;72(4):506-515. doi: 10.1016/j.bjane.2021.09.015. Epub 2021 Oct 18.
PubMed 34673125Priya TK, Singla D, Talawar P, Sharma RS, Goyal S, Purohit G. Comparative efficacy of quadratus lumborum type-II and erector spinae plane block in patients undergoing caesarean section under spinal anaesthesia: a randomised controlled trial. Int J Obstet Anesth. 2023 Feb;53:103614. doi: 10.1016/j.ijoa.2022.103614. Epub 2022 Dec 6.
PubMed 36535864Yu L, Shen X, Liu H. The effect and safety of dexmedetomidine as an adjuvant to local anesthetics in erector spinae plane block: a systematic review and meta-analysis of randomized controlled trials. BMC Anesthesiol. 2023 Feb 27;23(1):61. doi: 10.1186/s12871-023-02019-x.
PubMed 36849910
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patients' Satisfaction for Pain Control Modalities After Caesarean Section Using Erector Spinae Plain Block Vs Lateral Quadratus Lumborum Block. a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06771466
- Acronym / sponsor ID
- FMASU R254/2024
- Conditions
- Satisfaction, Pain Management After Surgery
- Keywords
- nerve block, pain, opioids, patient satisfaction, cesarean section
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- Wael Sayed El GharabawyUniversity, hospital or other
- Study start
- Mar 2025 (estimated)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 13 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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].
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.
- Sample Size: Sample size was calculated using PASS II software. setting the type-1 error (α) at 0.05 , power (1-β) at 0.8 and confidence width level at 0.1 , Calculation according to the values of previous studies' Comparative efficacy of quadratus lumborum type II and erector spinae plane block in patients undergoing caesarean section under spinal anesthesia: a randomized controlled trial produced a sample size of at least 63 cases for each group.
- Ethical Considerations: The study will be conducted after approval by the Research Ethics Committee of the Faculty of Medicine, Ain Shams University, and conducted in accordance with the principles of the Declaration of Helsinki. A written informed consent before enrolment will be taken.
- Study Procedures:
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.
- Statistical analysis All statistical procedures will be conducted using SPSS version 20 for Windows (SPSS Inc, Chicago, IL, USA).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- To investigate the difference in patient satisfaction following Erector spinae plane block (ESP) and Quadratus Lumborum block lateral approach after caesarean surgery, either alone or as part of multimodal analgesia.
| Arm | Type | Receives |
|---|---|---|
| Bilateral Ultrasound-Guided Erector Spinae Plane Block (group E) | Active comparator | Procedure: 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 |
| Bilateral Ultrasound-guided Quadratus Lumborum, Lateral approach (group Q) | Sham comparator | 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. |
Who may qualify
- Ages
- Up to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Parturient female
- Scheduled for elective cesarean section
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bilateral Ultrasound-Guided Erector Spinae Plane Block (group E)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. | Procedure or surgery | Bilateral Ultrasound-Guided Erector Spinae Plane Block (group E) |
| Bilateral Ultrasound-guided Quadratus Lumborum, Lateral approach (group Q)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 | Procedure or surgery | Bilateral Ultrasound-guided Quadratus Lumborum, Lateral approach (group Q) |
Primary outcome
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.
1 secondary outcome
to test the difference between the two approaches on the hospital discharge
Time frame: 24-48 hours after the surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2025.
- Background: PubMed 20142348Ong CK, Seymour RA, Lirk P, Merry AF. Combining paracetamol (acetaminophen) with nonsteroidal antiinflammatory drugs: a qualitative systematic review of analgesic efficacy for acute postoperative pain. Anesth Analg. 2010 Apr 1;110(4):1170-9. doi: 10.1213/ANE.0b013e3181cf9281. Epub 2010 Feb 8.
- Background: PubMed 28131114Sutton CD, Carvalho B. Optimal Pain Management After Cesarean Delivery. Anesthesiol Clin. 2017 Mar;35(1):107-124. doi: 10.1016/j.anclin.2016.09.010. Epub 2016 Dec 12.
- Background: PubMed 27891579Wikner M. Unexpected motor weakness following quadratus lumborum block for gynaecological laparoscopy. Anaesthesia. 2017 Feb;72(2):230-232. doi: 10.1111/anae.13754. Epub 2016 Nov 28.
- Background: PubMed 34673125Ribeiro Junior IDV, Carvalho VH, Brito LGO. Erector spinae plane block for analgesia after cesarean delivery: a systematic review with meta-analysis. Braz J Anesthesiol. 2022 Jul-Aug;72(4):506-515. doi: 10.1016/j.bjane.2021.09.015. Epub 2021 Oct 18.
- Background: PubMed 36535864Priya TK, Singla D, Talawar P, Sharma RS, Goyal S, Purohit G. Comparative efficacy of quadratus lumborum type-II and erector spinae plane block in patients undergoing caesarean section under spinal anaesthesia: a randomised controlled trial. Int J Obstet Anesth. 2023 Feb;53:103614. doi: 10.1016/j.ijoa.2022.103614. Epub 2022 Dec 6.
- Background: PubMed 36849910Yu L, Shen X, Liu H. The effect and safety of dexmedetomidine as an adjuvant to local anesthetics in erector spinae plane block: a systematic review and meta-analysis of randomized controlled trials. BMC Anesthesiol. 2023 Feb 27;23(1):61. doi: 10.1186/s12871-023-02019-x.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Wael S El Gharabawy, MD principal investigator
Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bilateral Ultrasound-Guided Erector Spinae Plane Block (group E) and Bilateral Ultrasound-guided Quadratus Lumborum, Lateral approach (group Q) in people with Satisfaction and Pain Management After Surgery, run by Wael Sayed El Gharabawy at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact wael S algharabawy, MD (00201096973949, gharabawy76@med.asu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To test whether the type of the plane block have an implication on the patients' satisfaction. (time frame: first 24 hours after the surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06771466, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2025.