Post Operative PainNCT06653803
Rhomboid Intercostal Block Versus Retrolaminar Block for Postoperative Analgesia After Thoracoscopic Sympathectomy
A study testing Rhomboid Intercostal Block (RIB) and Retrolaminar Block (RLB) in people with Post Operative Pain, run by Damanhour Teaching Hospital at 1 site in Egypt.
Trial summary
Background: Although thoracoscopic sympathectomy is made via small incisions, it is associated with severe postoperative pain. Both Rhomboid intercostal block (RIB) and Retrolaminar block (RLB) are recent techniques used for pain control after such procedures Objectives: To compare the effectiveness of RIB and RLB in… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Post Operative Pain
- What is being tested?
- Rhomboid Intercostal Block (RIB) and Retrolaminar Block (RLB)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2026to 30 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- American Society of Anesthesiologists (ASA) physical status ≤ II
- Age from 18 to 60 years
- Body Mass Index (BMI) < 35 kg/m²
Who cannot join
- American Society of Anesthesiologists (ASA) physical status > II
- Age < 18 years or > 60 years
- Body Mass Index (BMI) ≥ 35
- Local infection at the puncture site
- Altered mental status
- Pregnant women
Show all 10Show fewer
- Allergy to study drugs
- Chronic pain
- Coagulation abnormalities or on anticoagulants
- Severe hepatic or kidney 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
Damanhour Teaching Hospital
Damanhūr, El-Beheira
Ahmed M Shaat, MD, 00201223482709, ahmedshaat99@gmail.com
About this study
Official title: Ultrasound-guided Rhomboid Intercostal Block Versus Retrolaminar Block for Postoperative Analgesia After Thoracoscopic Sympathectomy: A Randomized Clinical Trial
Background: Although thoracoscopic sympathectomy is made via small incisions, it is associated with severe postoperative pain. Both Rhomboid intercostal block (RIB) and Retrolaminar block (RLB) are recent techniques used for pain control after such procedures
Objectives: To compare the effectiveness of RIB and RLB in providing postoperative analgesia after thoracoscopic sympathectomy in adult patients and their impact on the patient's outcomes.
Patients and Methods: This prospective, randomized (1:1), double-blind clinical trial; will be carried out on 60 patients scheduled for elective thoracoscopic sympathectomy under general anesthesia at our hospital. Patients will be randomly allocated into two equal groups (30 patients each) and will receive: in group A; general anesthesia with intraoperative ipsilateral ultrasound-guided RIB, whereas in group B; general anesthesia with intraoperative ipsilateral ultrasound-guided RLB.
- Conditions
- Post Operative Pain
- Being tested
- Rhomboid Intercostal Block (RIB), Retrolaminar Block (RLB)
- Keywords
- Rhomboid Intercostal Block, Retrolaminar Block, Regional Analgesia
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rhomboid Intercostal Block (RIB)Procedure or surgery
Intraoperative Ipsilateral Ultrasound-guided RIB
Retrolaminar Block (RLB)Procedure or surgery
Intraoperative Ipsilateral Ultrasound-guided RLB
| Study group | Role | What they receive |
|---|---|---|
| Group A (n=30) | Active comparator | Rhomboid Intercostal Block Receives: Procedure: Rhomboid Intercostal Block (RIB) |
| Group B (n=30) | Active comparator | Retrolaminar Block Receives: Procedure: Retrolaminar Block (RLB) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean and Standard deviation of time to the first request of postoperative rescue analgesic (minutes) (mean±SD)
The time interval between the block performance and the first request of postoperative analgesia
Measured: 24 hours after the end of surgery
Secondary outcomes (2)
Mean and Standard deviation of Numeric Pain Rating Scale (NPRS) score (mean±SD)
NPRS measures the severity of postoperative pain, it is a 11 point scale from 0-10; where 0=No pain and 10=Worst possible pain (At PACU, 1h, 3h, 6h, 12h, 18h, 24h) after the end of surgery
Measured: 24 hours after the end of surgery
Mean and Standard deviation of the total dose of the rescue analgesic consumed (milligrams) (mean±SD)
The total dose of the rescue analgesic consumed in the first 24 hours after the end of surgery
Measured: 24 hours after the end of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2024
- Study start1 Aug 2026
- Primary completion1 Jan 2027 (estimated)
- Study completion30 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Operative PainStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Damanhour Teaching Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Ahmed M Shaat, MD, Principal investigator, Damanhour Teaching Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06653803
- Sponsor's protocol ID
- DTH: 24001
- Status last verified
- Jul 2026
- First submitted
- 21 Oct 2024
- Last updated
- 21 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-guided Rhomboid Intercostal Block Versus Retrolaminar Block for Postoperative Analgesia After Thoracoscopic Sympathectomy: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06653803
- Acronym / sponsor ID
- DTH: 24001
- Conditions
- Post Operative Pain
- Keywords
- Rhomboid Intercostal Block, Retrolaminar Block, Regional Analgesia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Damanhour Teaching HospitalOther government
- Study start
- 1 Aug 2026 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 30 Jan 2027 (estimated)
- First posted
- 22 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.
Background: Although thoracoscopic sympathectomy is made via small incisions, it is associated with severe postoperative pain. Both Rhomboid intercostal block (RIB) and Retrolaminar block (RLB) are recent techniques used for pain control after such procedures
Objectives: To compare the effectiveness of RIB and RLB in providing postoperative analgesia after thoracoscopic sympathectomy in adult patients and their impact on the patient's outcomes.
Patients and Methods: This prospective, randomized (1:1), double-blind clinical trial; will be carried out on 60 patients scheduled for elective thoracoscopic sympathectomy under general anesthesia at our hospital. Patients will be randomly allocated into two equal groups (30 patients each) and will receive: in group A; general anesthesia with intraoperative ipsilateral ultrasound-guided RIB, whereas in group B; general anesthesia with intraoperative ipsilateral ultrasound-guided RLB.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A (n=30) | Active comparator | Procedure: Rhomboid Intercostal Block (RIB)Rhomboid Intercostal Block |
| Group B (n=30) | Active comparator | Procedure: Retrolaminar Block (RLB)Retrolaminar Block |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- American Society of Anesthesiologists (ASA) physical status ≤ II
- Age from 18 to 60 years
- Body Mass Index (BMI) < 35 kg/m²
Key exclusion criteria (10 listed)
- American Society of Anesthesiologists (ASA) physical status > II
- Age < 18 years or > 60 years
- Body Mass Index (BMI) ≥ 35
- Local infection at the puncture site
- Altered mental status
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 |
|---|---|---|
| Rhomboid Intercostal Block (RIB)Intraoperative Ipsilateral Ultrasound-guided RIB | Procedure or surgery | Group A (n=30) |
| Retrolaminar Block (RLB)Intraoperative Ipsilateral Ultrasound-guided RLB | Procedure or surgery | Group B (n=30) |
Primary outcome
Mean and Standard deviation of time to the first request of postoperative rescue analgesic (minutes) (mean±SD)
Time frame: 24 hours after the end of surgery
The time interval between the block performance and the first request of postoperative analgesia
2 secondary outcomes
Mean and Standard deviation of Numeric Pain Rating Scale (NPRS) score (mean±SD)
Time frame: 24 hours after the end of surgery
Mean and Standard deviation of the total dose of the rescue analgesic consumed (milligrams) (mean±SD)
Time frame: 24 hours after the end of 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 21 Sep 2026.
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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.
Ahmed M Shaat, MD principal investigator
Damanhour Teaching Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rhomboid Intercostal Block (RIB) and Retrolaminar Block (RLB) in people with Post Operative Pain, run by Damanhour Teaching Hospital 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 3 inclusion and 10 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 21 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 Ahmed M Shaat, MD (00201223482709, ahmedshaat99@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean and Standard deviation of time to the first request of postoperative rescue analgesic (minutes) (mean±SD) (time frame: 24 hours after the end of surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Sep 2026.