Cancer LiverNCT06621472
Retrolaminar Block Versus Subcostal Transversus Abdominis Plane Block in Liver Resection Surgery
A study testing Retrolaminar block group, subcostal TAP technique and thoracic Epidural in people with Cancer Liver, run by Cairo University at 1 site in Egypt.
Trial summary
Adequate pain control improves postoperative outcomes and is imperative for enhanced recovery after surgery (ERAS) . Open liver resection surgery is associated with intraoperative blood loss, hypotension, coagulopathy, pulmonary complications, liver impairment, and renal impairment, making perioperative pain… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cancer Liver
- What is being tested?
- Retrolaminar block group, subcostal TAP technique and thoracic Epidural
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2024to 1 Jan 2027
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Physical status American Society of Anesthesiologists (ASA)II, III. Body mass index (BMI): 20-35 kg/m2.
Who cannot join
- 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.
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, 1 recruiting
- Recruiting
Cairo University
Cairo, 11835
sayed M abed, MD degree, 01226806532 ext. +20, sydabed2020@outlook.com
About this study
Official title: Retrolaminar Block Versus Subcostal Transversus Abdominis Plane Block in Patients Undergoing Open Liver Resection Surgery
Adequate pain control improves postoperative outcomes and is imperative for enhanced recovery after surgery (ERAS) . Open liver resection surgery is associated with intraoperative blood loss, hypotension, coagulopathy, pulmonary complications, liver impairment, and renal impairment, making perioperative pain management challenging . Multimodal analgesic strategies employing regional techniques decrease postoperative pain and opioid consumption following liver resections. Thoracic epidural analgesia (TEA) is considered the 'gold standard' for open thoracic and abdominal surgical procedures .
Read the 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.
- Conditions
- Cancer Liver
- Being tested
- Retrolaminar block group, subcostal TAP technique, thoracic Epidural
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Retrolaminar block groupProcedure or surgery
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.
subcostal TAP techniqueOther
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
thoracic EpiduralOther
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.
| Study group | Role | What they receive |
|---|---|---|
| • Group R: Retrolaminar block (RLB) | Experimental | Patients will receive bilateral ultrasound guided retrolaminar block with injection of 20 ml bupivacaine 0.25% in each side. Receives: Procedure: Retrolaminar block group |
| Group T. Subcostal transversus abdominis plane block (STAP) | Experimental | Patients will receive bilateral Ultrasound guided subcostal TAP with injection of 20 ml bupivacaine 0.25% in each side. Receives: Other: subcostal TAP technique |
| Epidural | Experimental | By loss of resistant technique and catheter insertion at the level of thoracic vertebrae (7-10) Receives: Other: thoracic Epidural |
What is being measured
The primary outcome is the main question the study is designed to answer.
post-operative analgesic consumption for 24 hours among study groups.
measuring total dose of narcotics required for the patient in study groups
Measured: for 24 hours postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2024
- Study start1 Oct 2024
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cancer LiverStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- double blind
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sayed Mahmoud Abed, Cairo University
- Investigators
- sayed M Abed, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06621472
- Sponsor's protocol ID
- analgesia in hepatectomy
- Status last verified
- Aug 2026
- First submitted
- 27 Sep 2024
- Last updated
- 1 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: shared through web
Publications
Joshi GP, Kehlet H. Postoperative pain management in the era of ERAS: An overview. Best Pract Res Clin Anaesthesiol. 2019 Sep;33(3):259-267. doi: 10.1016/j.bpa.2019.07.016. Epub 2019 Jul 25.
PubMed 31785712
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrolaminar Block Versus Subcostal Transversus Abdominis Plane Block in Patients Undergoing Open Liver Resection Surgery
- ClinicalTrials.gov ID
- NCT06621472
- Acronym / sponsor ID
- analgesia in hepatectomy
- Conditions
- Cancer Liver
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 1 Oct 2024 (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.
Adequate pain control improves postoperative outcomes and is imperative for enhanced recovery after surgery (ERAS) . Open liver resection surgery is associated with intraoperative blood loss, hypotension, coagulopathy, pulmonary complications, liver impairment, and renal impairment, making perioperative pain management challenging . Multimodal analgesic strategies employing regional techniques decrease postoperative pain and opioid consumption following liver resections. Thoracic epidural analgesia (TEA) is considered the 'gold standard' for open thoracic and abdominal surgical procedures .
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- double blind
| Arm | Type | Receives |
|---|---|---|
| • Group R: Retrolaminar block (RLB) | Experimental | Procedure: Retrolaminar block groupPatients will receive bilateral ultrasound guided retrolaminar block with injection of 20 ml bupivacaine 0.25% in each side. |
| Group T. Subcostal transversus abdominis plane block (STAP) | Experimental | Other: subcostal TAP techniquePatients will receive bilateral Ultrasound guided subcostal TAP with injection of 20 ml bupivacaine 0.25% in each side. |
| Epidural | Experimental | Other: thoracic EpiduralBy loss of resistant technique and catheter insertion at the level of thoracic vertebrae (7-10) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Physical status American Society of Anesthesiologists (ASA)II, III. Body mass index (BMI): 20-35 kg/m2.
Key exclusion criteria (3 listed)
- 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.
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 |
|---|---|---|
| Retrolaminar block grouppatients 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. | Procedure or surgery | • Group R: Retrolaminar block (RLB) |
| subcostal TAP techniqueThe 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 | Other | Group T. Subcostal transversus abdominis plane block (STAP) |
| thoracic EpiduralBefore 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. | Other | Epidural |
Primary outcome
post-operative analgesic consumption for 24 hours among study groups.
Time frame: for 24 hours postoperative
measuring total dose of narcotics required for the patient in study groups
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 1 Sep 2026.
- Background: PubMed 31785712Joshi GP, Kehlet H. Postoperative pain management in the era of ERAS: An overview. Best Pract Res Clin Anaesthesiol. 2019 Sep;33(3):259-267. doi: 10.1016/j.bpa.2019.07.016. Epub 2019 Jul 25.
- Agarwal V, Divatia JV: Enhanced recovery after surgery in liver resection: current concepts and controversies. Korean J Anesthesiol. 2019, 72:119-29. 10.4097/kja.d.19.00010Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. shared through web
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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.
sayed M Abed principal investigator
Cairo 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 Retrolaminar block group, subcostal TAP technique and thoracic Epidural in people with Cancer Liver, run by Cairo University 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 1 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 1 Sep 2026. 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. 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 sayed M abed, MD degree (1226806532 ext. +20, sydabed2020@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
post-operative analgesic consumption for 24 hours among study groups. (time frame: for 24 hours postoperative). 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 NCT06621472, which also lists 1 linked publication.
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 1 Sep 2026.