Bilateral Rectus Sheath BlockNCT07634731
Bilateral RSB vs TEA Epidural Analgesia for Postoperative Pain Control After Open Gastrectomy: A Randomized Controlled Trial
A study of Bilateral Rectus Sheath Block and Thoracic Epidural Analgesia, run by Igors Ivanovs at 1 site in Latvia.
Trial summary
Patients indicated for elective open gastrectomy were screened, enrolled, and randomised between October 2021 and September 2023. The patients were randomised to either Group A (intervention-continuous bupivacaine) or Group B (control-NaCl saline). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bilateral Rectus Sheath Block, Thoracic Epidural Analgesia
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteLatvia
- Study dates
- 1 Oct 2021to 1 Dec 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- (ASA) Grades I to III.
- all adult patients (≥18 years) scheduled for elective open gastrectomy
Who cannot join
- those requiring acute gastric surgery,
- individuals with known bupivacaine allergies
- and patients who declined analgesia via RSB catheters and continuous bupivacaine infusions.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Bilateral Rectus Sheath Block and Thoracic Epidural Analgesia for Postoperative Pain Control After Open Gastrectomy
Patients indicated for elective open gastrectomy were screened, enrolled, and randomised between October 2021 and September 2023. The patients were randomised to either Group A (intervention-continuous bupivacaine) or Group B (control-NaCl saline). The primary outcome measures were the quantity of an opioid analgesic administered during the initial 72 h post-surgery and the level of postoperative pain as indicated by the visual analogue scale (VAS
- Being tested
- Bilateral Rectus Sheath Block and Thoracic Epidural Analgesia for Postoperative Pain Control After Open Gastrectomy.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bilateral Rectus Sheath Block and Thoracic Epidural Analgesia for Postoperative Pain Control After Open Gastrectomy.Procedure or surgery
The surgical procedure involved an upper middle laparotomy. Prior to the surgery, standard preoperative monitoring was conducted, including venous access placement, pulse oximetry, electrocardiography, and automated non-invasive arterial blood pressure measurement. General anesthesia was administered through both intravenous and endotracheal methods following standard protocols.
| Study group | Role | What they receive |
|---|---|---|
| VAS | Experimental | Visual analog scale Receives: Procedure: Bilateral Rectus Sheath Block and Thoracic Epidural Analgesia for Postoperative Pain Control After Open Gastrectomy. |
| Postoperative recovery | Active comparator | Days Receives: Procedure: Bilateral Rectus Sheath Block and Thoracic Epidural Analgesia for Postoperative Pain Control After Open Gastrectomy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain Assessment
VAS
Measured: 12 weeks
Secondary outcomes (4)
Postoperative Recovery
Postoperative bowel movement
Measured: 12 weeks
Rescue Pain Management and Analgesia
Use of additional NSAIDs
Measured: 12 weeks
Postoperative recovery
Postoperative days
Measured: 12 weeks
Opioids
Use of opioids postoperatively
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2026
- Study start1 Oct 2021
- Primary completion1 Oct 2024
- Study completion1 Dec 2024
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 Bilateral Rectus Sheath BlockStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Igors Ivanovs
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Igors Ivanovs, Riga East Clinical University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07634731
- Sponsor's protocol ID
- 002
- Status last verified
- Jun 2026
- First submitted
- 13 May 2026
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Publish study in Journal "Medicina" MDPI
Publications
Opincans J, Ivanovs I, Miscuks A, Pavulans J, Zemite E, Rudzats A, Kecbaja Z, Kaminskis A. Comparison of Bilateral Rectus Sheath Block and Thoracic Epidural Analgesia for Postoperative Pain Control After Open Gastrectomy: A Randomized Controlled Trial. Medicina (Kaunas). 2025 Sep 18;61(9):1695. doi: 10.3390/medicina61091695.
PubMed 41011085
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Bilateral Rectus Sheath Block and Thoracic Epidural Analgesia for Postoperative Pain Control After Open Gastrectomy
- ClinicalTrials.gov ID
- NCT07634731
- Acronym / sponsor ID
- 002
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Igors IvanovsOther government
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 1 Oct 2024 (actual)
- Study completion
- 1 Dec 2024 (actual)
- First posted
- 9 Jun 2026 (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.
Patients indicated for elective open gastrectomy were screened, enrolled, and randomised between October 2021 and September 2023. The patients were randomised to either Group A (intervention-continuous bupivacaine) or Group B (control-NaCl saline). The primary outcome measures were the quantity of an opioid analgesic administered during the initial 72 h post-surgery and the level of postoperative pain as indicated by the visual analogue scale (VAS
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VAS | Experimental | Procedure: Bilateral Rectus Sheath Block and Thoracic Epidural Analgesia for Postoperative Pain Control After Open Gastrectomy.Visual analog scale |
| Postoperative recovery | Active comparator | Procedure: Bilateral Rectus Sheath Block and Thoracic Epidural Analgesia for Postoperative Pain Control After Open Gastrectomy.Days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- (ASA) Grades I to III.
- all adult patients (≥18 years) scheduled for elective open gastrectomy
Key exclusion criteria (3 listed)
- those requiring acute gastric surgery,
- individuals with known bupivacaine allergies
- and patients who declined analgesia via RSB catheters and continuous bupivacaine infusions.
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 |
|---|---|---|
| Bilateral Rectus Sheath Block and Thoracic Epidural Analgesia for Postoperative Pain Control After Open Gastrectomy.The surgical procedure involved an upper middle laparotomy. Prior to the surgery, standard preoperative monitoring was conducted, including venous access placement, pulse oximetry, electrocardiography, and automated non-invasive arterial blood pressure measurement. General anesthesia was administered through both intravenous and endotracheal methods following standard protocols. | Procedure or surgery | Postoperative recovery, VAS |
Primary outcome
Postoperative Pain Assessment
Time frame: 12 weeks
VAS
4 secondary outcomes
Postoperative Recovery
Time frame: 12 weeks
Rescue Pain Management and Analgesia
Time frame: 12 weeks
Postoperative recovery
Time frame: 12 weeks
Opioids
Time frame: 12 weeks
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 9 Sep 2026.
- Results publication: PubMed 41011085Opincans J, Ivanovs I, Miscuks A, Pavulans J, Zemite E, Rudzats A, Kecbaja Z, Kaminskis A. Comparison of Bilateral Rectus Sheath Block and Thoracic Epidural Analgesia for Postoperative Pain Control After Open Gastrectomy: A Randomized Controlled Trial. Medicina (Kaunas). 2025 Sep 18;61(9):1695. doi: 10.3390/medicina61091695.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. Publish study in Journal "Medicina" MDPI
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Bilateral Rectus Sheath Block and Thoracic Epidural Analgesia, run by Igors Ivanovs at 1 site in Latvia.
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 2 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: finished, as of the sponsor's last update on 9 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 Latvia. 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?
Postoperative Pain Assessment (time frame: 12 weeks). 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 NCT07634731, 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 9 Sep 2026.