- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06621472
Retrolaminar Block Versus Subcostal Transversus Abdominis Plane Block in Liver Resection Surgery
Retrolaminar Block Versus Subcostal Transversus Abdominis Plane Block in Patients Undergoing Open Liver Resection Surgery
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The retrolaminar block (RLB) is a modified paravertebral block that administers local anesthetic between the lamina of the thoracic vertebra and the erector spinae muscles, using landmark technique or under ultrasound guidance, rather than entering the needle into the thoracic paravertebral space (TPVS) directly. Moreover, real-time ultrasound guidance can help identify the lamina and monitor the spread of local anesthetic .
Ultrasound-guided Subcostal Transversus Abdominis Plane (TAP) Block is proven to provide adequate analgesia for upper and lower abdominal surgeries. A local anesthetic (LA) is deposited in the plane between the transversus abdominis and posterior sheath of the rectus muscle in the subcostal region to anesthetize the anterior cutaneous branches of the lower intercostal nerves (T7-T11). In this study, we aimed to compare the analgesic effect of RLB and subcostal TAP block in patients undergoing open liver resection surgery.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: sayed M abed, MD degree
- Phone Number: +20 1226806532
- Email: sydabed2020@outlook.com
Study Locations
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-
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Cairo, Egypt, 11835
- Recruiting
- Cairo University
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Contact:
- sayed M abed, MD degree
- Phone Number: +20 01226806532
- Email: sydabed2020@outlook.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Physical status American Society of Anesthesiologists (ASA)II, III. Body mass index (BMI): 20-35 kg/m2.
Exclusion Criteria:
Patient refusal Physical status ASA IV BMI < 20 kg/m2 and >35 kg/m2 known sensitivity or contraindication to drug used in the study (local anesthetics, opioids).
History of psychological disorders and/or chronic pain. Contraindication to regional anesthesia e.g., local sepsis, pre- existing peripheral neuropathies, and coagulopathy.
Severe respiratory, cardiac disorders and renal disease.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: • Group R: Retrolaminar block (RLB)
Patients will receive bilateral ultrasound guided retrolaminar block with injection of 20 ml bupivacaine 0.25% in each side.
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patients will be placed in a sitting position.
The transducer will be positioned vertically 3 cm lateral to the midline at the level of the 7th thoracic transverse process.
The muscles of the back, the transverse process, and the pleura between two transverse processes will be visualized.
The needle will be introduced in a cranial-caudal direction toward the lamina using the in-plane method until the tip lay in the lamina 1 mL of normal saline will be injected to confirm the correct needle tip position by visualizing the spread.
After negative aspiration, 20 mL of 0.25% isobaric bupivacaine.
The procedure will be repeated on the opposite side.
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Experimental: Group T. Subcostal transversus abdominis plane block (STAP)
Patients will receive bilateral Ultrasound guided subcostal TAP with injection of 20 ml bupivacaine 0.25% in each side.
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The transducer will be placed obliquely along the subcostal margin near the xiphisternum in the midline of the abdomen.
The rectus abdominis muscle and underlying transversus abdominis muscle will be identified.
The position of the transversus abdominis muscle will be confirmed by sliding the transducer laterally until the aponeuroses of the external and internal oblique muscle will be visualized.
The transversus abdominis muscle will be then identified, being posterior to the internal oblique muscle and will be followed back medially to confirm its position beneath the rectus muscle.
the needle will be introduced through the rectus muscle in a superomedial-to-inferolateral direction towards the transversus abdominis muscle using the in-plane method, and 20 mL of 0.25% isobaric bupivacaine will be injected
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Experimental: Epidural
By loss of resistant technique and catheter insertion at the level of thoracic vertebrae (7-10)
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Before induction of general anesthesia the epidural catheter was inserted under sterile condition with a loss of resistance technique by an 18G needle at a mid-thoracic level (Th 7-10) to cover the dermatomes innervating the incision in the upper abdomen.
The epidural infusion consisting of bupivacaine 1 mg/mL, and fentanyl 2 μg/mL was activated on the attending anesthesiologist's decision.
Following the hospital protocols, the infusion rate was initiated at 5-10 mL/h, increased to maximum 15 mL/h if necessary, bolus dose of 5 mL was allowed every 30 minutes.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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post-operative analgesic consumption for 24 hours among study groups.
Time Frame: for 24 hours postoperative
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measuring total dose of narcotics required for the patient in study groups
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for 24 hours postoperative
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: sayed M Abed, Cairo University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
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
- Neoplasms by Site
- Neoplasms
- Neoplasms by Histologic Type
- Digestive System Neoplasms
- Digestive System Diseases
- Liver Diseases
- Neoplasms, Glandular and Epithelial
- Adenocarcinoma
- Liver Neoplasms
- Carcinoma
- Carcinoma, Hepatocellular
- Diet, Food, and Nutrition
- Physiological Phenomena
- Food and Beverages
- Beverages
- Plant Preparations
- Biological Products
- Complex Mixtures
- Tea
Other Study ID Numbers
- analgesia in hepatectomy
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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