- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06451354
Postoperative Analgesia After Cesarean Section; Comparison Among Ultrasound Guided Erector Spinae, Quadratus Lumborum or Transversus Abdominis Plane Blocks
Postoperative Analgesia After Cesarean Section; Comparison Among Ultrasound Guided Erector Spinae, Quadratus Lumborum or Transversus Abdominis Plane Blocks: A Prospective Randomized Study
Study Overview
Status
Conditions
Detailed Description
Acute postpartum pain is a key determinant of maternal satisfaction; may lead to persistent postoperative pain.
Opioids are used to control severe pain. However, they have many common side effects as sedation, dizziness, nausea, vomiting, constipation, physical dependence, tolerance, and respiratory depression.
Transversus abdominis plane (TAP) block is a regional injection of local anesthetic between the transversus abdominis and internal oblique muscle planes. TAP block affects the sensory nerves of the anterolateral abdominal wall (T6-L1) that innervate the abdomen. TAP block is an easy technique, and decreases postoperative pain and opioid consumption.
Erector Spinae Plane block (ESPB), first described for analgesia in thoracic neuropathic pain has also been reported for the management of other causes of acute postoperative pain.
Quadratus Lumborum block (QLB) differ from the transversus abdominis plane block (TAP) it is a block of the posterior abdominal wall. It is also referred to as an inter fascial plane block because it requires the injection of a local anesthetic into the thoracolumbar fascia (TLF).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Kafrelsheikh
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Kafr Ash Shaykh, Kafrelsheikh, Egypt, 33516
- Kafrelsheikh University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age ≥ 18 years.
- American Society of Anesthesiologists (ASA) classification II.
- Female patients scheduled for elective cesarean section under spinal anesthesia.
Exclusion Criteria:
- Patient refusal.
- Patients who are taking analgesics for chronic illness or have history of substance abuse.
- Patients who are unable to describe their postoperative pain (e.g., language barrier or neuropsychiatric disorder).
- Patients with a history of coagulopathy.
- Patients weight less than 60 kilograms.
- Patient height less than 150 cm.
- Patients with known local anesthetics and opioid allergy.
- Patients with infection at the site of the needle puncture.
- Patients with major respiratory, cardiac, renal, or hepatic disorders.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control group
Patients will receive the standard spinal anesthesia with 0.5% hyperbaric bupivacaine (2.2ml)
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|
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Experimental: Erector spinae plane block group
Patients will receive bilateral ultrasound-guided erector spinae plane block after spinal anesthesia and at the end of surgery.
The erector spinae plane block will be performed by using bupivacaine 0.25% (20 ml in each side).
Erector spinae plane block will be performed at the level of T9.
|
Patients will receive bilateral ultrasound-guided erector spinae plane block after spinal anesthesia and at the end of surgery.
The erector spinae plane block will be performed by using bupivacaine 0.25% (20 ml in each side).
Erector spinae plane block will be performed at the level of T9.
|
|
Experimental: Posterior Quadratus lumborum plane block group
Patients will receive bilateral ultrasound-guided quadratus lumborum plane block after spinal anesthesia at the end of surgery.
The quadratus lumborum plane block will be performed by using bupivacaine 0.25% (20 ml in each side).
|
Patients will receive bilateral ultrasound-guided quadratus lumborum plane block after spinal anesthesia at the end of surgery.
The quadratus lumborum plane block will be performed by using bupivacaine 0.25% (20 ml in each side).
|
|
Experimental: Lateral Transversus abdominis plane block group
Patients will receive bilateral ultrasound-guided transversus abdominis plane block after spinal anesthesia at the end of surgery.
The transversus abdominis plane block will be performed by using bupivacaine 0.25% (20 ml in each side) to the lateral abdominal wall in the mid-axillary line, between the lower costal margin and iliac crest.
|
Patients will receive bilateral ultrasound-guided transversus abdominis plane block after spinal anesthesia at the end of surgery.
The transversus abdominis plane block will be performed by using bupivacaine 0.25% (20 ml in each side) to the lateral abdominal wall in the mid-axillary line, between the lower costal margin and iliac crest.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postoperative morphine consumption
Time Frame: 24 hours postoperatively
|
The rescue analgesia will be morphine IV bolus 3 mg with 5-minute lock out interval when Numeric Rating Scale (NRS)>3, can be repeated till NRS˂3 guided with the occurrence of complication.
|
24 hours postoperatively
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Degree of pain
Time Frame: 24 hours postoperatively
|
Each patient will be instructed about postoperative pain assessment with the numeric rating scale (NRS) score.
NRS (0 represents "no pain" while 10 represents "the worst pain imaginable").
NRS will be assessed at T1, 2, 4, 6, 12, 18, and 24 h postoperative.
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24 hours postoperatively
|
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Time for first request of the rescue analgesia
Time Frame: 24 hours postoperatively
|
Time for first request of the rescue analgesia will be assessed from the end of surgery to first dose of morphine administrated.
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24 hours postoperatively
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Complications
Time Frame: 24 hours postoperatively
|
Complications such as local anesthetic systemic toxicity (LAST), bradycardia, hypotension, nausea, vomiting, respiratory depression or any other complication will be recorded.
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24 hours postoperatively
|
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Degree of patient satisfaction
Time Frame: 24 hours postoperatively
|
Degree of patient satisfaction will be assessed using 4-point scale (1, excellent; 2, good; 3, fair; 4, poor).
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24 hours postoperatively
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 35439/4/22
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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