Postoperative AnalgesiaNCT06710444
Erector Spinae Plane Block Versus Retrolaminar Block for Analgesia in Percutaneous Nephrolithotomy
A study testing ultrasound-guided erector spinae plane block and ultrasound-guided retrolaminar plane block in people with Postoperative Analgesia and Pain Management, run by Alexandria University at 1 site in Egypt.
Trial summary
The study will investigate the effects of ultrasound-guided ESPB and RLB on intraoperative and postoperative analgesia in patients undergoing PCNL to identify a safe and effective regional block method for postoperative analgesia Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Postoperative Analgesia, Pain Management, PCNL
- What is being tested?
- ultrasound-guided erector spinae plane block and ultrasound-guided retrolaminar plane block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2024to 1 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients scheduled for PCNL
Who cannot join
- daily consumption of analgesics
- allergy to local anesthetics
- liver dysfunction
- infection or previous surgery in the vertebral region.
- patient refusal
- pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ultrasound-guided Erector Spinae Plane Block Versus Retrolaminar Block for Postoperative Analgesia in Patients Undergoing Percutaneous Nephrolithotomy
The study will investigate the effects of ultrasound-guided ESPB and RLB on intraoperative and postoperative analgesia in patients undergoing PCNL to identify a safe and effective regional block method for postoperative analgesia
Read the detailed description
All the patients will be blinded to the intervention received in this study. All patients will receive standard general anesthesia technique with endotracheal intubation and muscle paralysis. Postoperatively, all patients will receive analgesia in the form of non-steroidal anti-inflammatory drugs and paracetamol. In case the VAS scores exceeded 4 in any group, the patients will receive rescue analgesia with 25 mg IV meperidine. In both groups, the ESPB and RLB will be performed after induction of general anesthesia using portable ultrasound device.
- Being tested
- ultrasound-guided erector spinae plane block, ultrasound-guided retrolaminar plane block
- Keywords
- Postoperative, Analgesia, Pain, Erector Spinae, Retrolaminar, Block, PCNL
- Medical subject headings
- Agnosia, Pain, Bites and Stings
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasound-guided erector spinae plane blockProcedure or surgery
ESPB
ultrasound-guided retrolaminar plane blockProcedure or surgery
RLB
| Study group | Role | What they receive |
|---|---|---|
| Group I | Active comparator | This group will receive ultrasound-guided erector spinae plane block Receives: Procedure: ultrasound-guided erector spinae plane block |
| Group II | Experimental | This group will receive ultrasound-guided Retrolaminar plane block Receives: Procedure: ultrasound-guided retrolaminar plane block |
What is being measured
The primary outcome is the main question the study is designed to answer.
measurement of visual analogue score
measurement of visual analogue score during rest and movement. The Score range from 0-10. 0 means no pain and 10 indicates the worst pain ever
Measured: after the surgery average 48 hours postoperative
Secondary outcomes (4)
postoperative additional analgesic requirement
Total cumulative analgesic requirement dose
Measured: after the surgery average 48 hours postoperative
assessing the patient satisfaction by a the short assessment of patient satisfaction score (SAPS)
from 0 to 28, where 0 is so dissatisfied and 28 means very satisfied
Measured: after the surgery average 48 hours postoperative
Time to ambulate
Time from discharge from the operating theatre to start to ambulate
Measured: after the surgery average 12 hours postoperative
presence of postoperative nausea and vomiting
Number of postoperative nausea and vomiting
Measured: after the surgery average 48 hours postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2024
- Study start1 Dec 2024
- Primary completion1 Mar 2025
- Study completion1 Apr 2025
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 Postoperative AnalgesiaStudies of the same condition, open and under way.
- More trials run by Alexandria 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
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Shehab, MD, Alexandria University
- Investigators
- Ahmed S. Shehab, MD, Principal investigator, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06710444
- Sponsor's protocol ID
- 0306627
- Status last verified
- May 2025
- First submitted
- 26 Nov 2024
- Last updated
- 14 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: there is a plan to make individual participant data (IPD) collected in this study, including data dictionaries, available to other researchers
Publications
Sotome S, Sawada A, Wada A, Shima H, Kutomi G, Yamakage M. Erector spinae plane block versus retrolaminar block for postoperative analgesia after breast surgery: a randomized controlled trial. J Anesth. 2021 Feb;35(1):27-34. doi: 10.1007/s00540-020-02855-y. Epub 2020 Sep 11.
PubMed 32915300
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-guided Erector Spinae Plane Block Versus Retrolaminar Block for Postoperative Analgesia in Patients Undergoing Percutaneous Nephrolithotomy
- ClinicalTrials.gov ID
- NCT06710444
- Acronym / sponsor ID
- 0306627
- Keywords
- Postoperative, Analgesia, Pain, Erector Spinae, Retrolaminar, Block, PCNL
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 1 Mar 2025 (actual)
- Study completion
- 1 Apr 2025 (actual)
- First posted
- 29 Nov 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.
The study will investigate the effects of ultrasound-guided ESPB and RLB on intraoperative and postoperative analgesia in patients undergoing PCNL to identify a safe and effective regional block method for postoperative analgesia
Detailed description
All the patients will be blinded to the intervention received in this study. All patients will receive standard general anesthesia technique with endotracheal intubation and muscle paralysis. Postoperatively, all patients will receive analgesia in the form of non-steroidal anti-inflammatory drugs and paracetamol. In case the VAS scores exceeded 4 in any group, the patients will receive rescue analgesia with 25 mg IV meperidine. In both groups, the ESPB and RLB will be performed after induction of general anesthesia using portable ultrasound device.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I | Active comparator | Procedure: ultrasound-guided erector spinae plane blockThis group will receive ultrasound-guided erector spinae plane block |
| Group II | Experimental | Procedure: ultrasound-guided retrolaminar plane blockThis group will receive ultrasound-guided Retrolaminar plane block |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients scheduled for PCNL
Key exclusion criteria (6 listed)
- daily consumption of analgesics
- allergy to local anesthetics
- liver dysfunction
- infection or previous surgery in the vertebral region.
- patient refusal
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 |
|---|---|---|
| ultrasound-guided erector spinae plane blockESPB | Procedure or surgery | Group I |
| ultrasound-guided retrolaminar plane blockRLB | Procedure or surgery | Group II |
Primary outcome
measurement of visual analogue score
Time frame: after the surgery average 48 hours postoperative
measurement of visual analogue score during rest and movement. The Score range from 0-10. 0 means no pain and 10 indicates the worst pain ever
4 secondary outcomes
postoperative additional analgesic requirement
Time frame: after the surgery average 48 hours postoperative
assessing the patient satisfaction by a the short assessment of patient satisfaction score (SAPS)
Time frame: after the surgery average 48 hours postoperative
Time to ambulate
Time frame: after the surgery average 12 hours postoperative
presence of postoperative nausea and vomiting
Time frame: after the surgery average 48 hours postoperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2025.
- Background: PubMed 32915300Sotome S, Sawada A, Wada A, Shima H, Kutomi G, Yamakage M. Erector spinae plane block versus retrolaminar block for postoperative analgesia after breast surgery: a randomized controlled trial. J Anesth. 2021 Feb;35(1):27-34. doi: 10.1007/s00540-020-02855-y. Epub 2020 Sep 11.
- Individual participant dataSharing planned: Yes. there is a plan to make individual participant data (IPD) collected in this study, including data dictionaries, available to other researchers
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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. This study is not recruiting at the moment.
Ahmed S. Shehab, MD principal investigator
Alexandria 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 ultrasound-guided erector spinae plane block and ultrasound-guided retrolaminar plane block in people with Postoperative Analgesia and Pain Management, run by Alexandria 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 6 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: finished, as of the sponsor's last update on 14 May 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
measurement of visual analogue score (time frame: after the surgery average 48 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 NCT06710444, 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 14 May 2025.