Postoperative PainNCT07705516
Interfascial Abdominal Wall Block for Gynecological Laparoskopy: A Randomized Clinical Trial
A study testing Bilateral QLB and RSB and Bilateral QLB alone in people with Postoperative Pain and Pelvic Pain, run by Medical and Diagnostic Center "MEDION" LLC at 1 site in Ukraine.
Trial summary
The purpose of this study is to evaluate the clinical efficacy of combining ultrasound-guided bilateral rectus sheath blocks (RSB) and quadratus lumborum blocks (QLB) compared to using a quadratus lumborum block alone for postoperative analgesia in patients undergoing laparoscopic gynecological surgeries. Read more about this study
- Who is it for?
- Ages 25 to 65 years, women only
- Conditions the study is for
- Postoperative Pain, Pelvic Pain
- What is being tested?
- Bilateral QLB and RSB and Bilateral QLB alone
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUkraine
- Study dates
- 7 Jan 2025to 28 Dec 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 25 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Scheduled for elective gynecological video-laparoscopic surgery.
- ASA physical status І-ІІ.
- Age between 18 and 65 years.
- Patient's informed consent to participate in the study
Who cannot join
- Known allergy or contraindications to local anesthetics.
- Infection at the potential needle insertion sites.
- Coagulopathy or ongoing anticoagulant therapy.
- Conversion to open laparotomy during surgery.
- Severe cognitive impairment or psychiatric disorders.
Trial locations and contacts
1 site in 1 country.
Ukraine1 site
Medical and Diagnostic Center "MEDION" LLC
Poltava, Poltava Oblast, 36039
About this study
Official title: Combined Rectus Sheath and Quadratus Lumborum Blocks Versus Quadratus Lumborum Block Alone for Movement-evoked Pain After Laparoscopic Gynecologic Surgery: a Prospective Randomized Open-label Trial
The purpose of this study is to evaluate the clinical efficacy of combining ultrasound-guided bilateral rectus sheath blocks (RSB) and quadratus lumborum blocks (QLB) compared to using a quadratus lumborum block alone for postoperative analgesia in patients undergoing laparoscopic gynecological surgeries.
The primary objective is to assess movement-evoked pain scores in the early postoperative period. Secondary objectives include the evaluation of postoperative opioid consumption, intraoperative hemodynamic stability, and the overall incidence of side effects. Investigators hypothesize that the combined interfacial abdominal wall block technique will provide superior pain relief and reduce opioid requirements during recovery.
- Conditions
- Postoperative Pain, Pelvic Pain
- Being tested
- Bilateral QLB and RSB, Bilateral QLB alone
- Keywords
- Quadratus Lumborum Block, Rectus Sheath Block, Laparoscopy, Gynecologic Surgical Procedures
- Medical subject headings
- Pain, Postoperative, Pelvic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bilateral QLB and RSBProcedure or surgery
Preoperative regional anesthesia. Bilateral QL block combined with bilateral RS block. Ultrasound-guided technique. Using local anesthetics.
Bilateral QLB aloneProcedure or surgery
Preoperative regional anesthesia. Isolated bilateral QL block. No rectus sheath block. Ultrasound-guided technique. Using local anesthetics.
| Study group | Role | What they receive |
|---|---|---|
| QLB + RSB Group | Experimental | Combined regional anesthesia. Bilateral QL block technique. Bilateral RSB technique. Ultrasound-guided injections. Standard local anesthetics. Postoperative pain management. Receives: Procedure: Bilateral QLB and RSB |
| QLB Group | Active comparator | Isolated regional anesthesia. Bilateral QLB technique. No rectus sheath block. Ultrasound-guided injections. Standard local anesthetics. Postoperative pain management. Receives: Procedure: Bilateral QLB alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain intensity
Visual Analog Scale (VAS) score. Scale from 0 to 10. 0 means no pain. 10 means worst pain. Lower scores sindicate less pain.
Measured: At 2, 4, 6, 12, and 24 hours postoperative assessment
Secondary outcomes (1)
Total opioid consumption. Postoperative period. Measured in milligrams.
Total dose of opioid analgesics. Administered within 24 hours. Measured in milligrams (mg). Lower doses indicate better opioid-sparing effect.
Measured: Within 24 hours after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2026
- Study start7 Jan 2025
- Primary completion27 Dec 2025
- Study completion28 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical and Diagnostic Center "MEDION" LLC
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Slipukha Denys, Medical and Diagnostic Center "MEDION" LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07705516
- Sponsor's protocol ID
- Protocol №17-01/06/2024
- Status last verified
- Jul 2026
- First submitted
- 10 Jul 2026
- Last updated
- 15 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared to protect patient privacy. All collected clinical data will remain confidential within the medical center. The study protocol and statistical methods may be available upon direct request.
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Rectus Sheath and Quadratus Lumborum Blocks Versus Quadratus Lumborum Block Alone for Movement-evoked Pain After Laparoscopic Gynecologic Surgery: a Prospective Randomized Open-label Trial
- ClinicalTrials.gov ID
- NCT07705516
- Acronym / sponsor ID
- Protocol №17-01/06/2024
- Conditions
- Postoperative Pain, Pelvic Pain
- Keywords
- Quadratus Lumborum Block, Rectus Sheath Block, Laparoscopy, Gynecologic Surgical Procedures
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Medical and Diagnostic Center "MEDION" LLCUniversity, hospital or other
- Study start
- 7 Jan 2025 (actual)
- Primary completion
- 27 Dec 2025 (actual)
- Study completion
- 28 Dec 2025 (actual)
- First posted
- 15 Jul 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.
The purpose of this study is to evaluate the clinical efficacy of combining ultrasound-guided bilateral rectus sheath blocks (RSB) and quadratus lumborum blocks (QLB) compared to using a quadratus lumborum block alone for postoperative analgesia in patients undergoing laparoscopic gynecological surgeries.
The primary objective is to assess movement-evoked pain scores in the early postoperative period. Secondary objectives include the evaluation of postoperative opioid consumption, intraoperative hemodynamic stability, and the overall incidence of side effects. Investigators hypothesize that the combined interfacial abdominal wall block technique will provide superior pain relief and reduce opioid requirements during recovery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| QLB + RSB Group | Experimental | Procedure: Bilateral QLB and RSBCombined regional anesthesia. Bilateral QL block technique. Bilateral RSB technique. Ultrasound-guided injections. Standard local anesthetics. Postoperative pain management. |
| QLB Group | Active comparator | Procedure: Bilateral QLB aloneIsolated regional anesthesia. Bilateral QLB technique. No rectus sheath block. Ultrasound-guided injections. Standard local anesthetics. Postoperative pain management. |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Scheduled for elective gynecological video-laparoscopic surgery.
- ASA physical status І-ІІ.
- Age between 18 and 65 years.
- Patient's informed consent to participate in the study
Key exclusion criteria (5 listed)
- Known allergy or contraindications to local anesthetics.
- Infection at the potential needle insertion sites.
- Coagulopathy or ongoing anticoagulant therapy.
- Conversion to open laparotomy during surgery.
- Severe cognitive impairment or psychiatric disorders.
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 QLB and RSBPreoperative regional anesthesia. Bilateral QL block combined with bilateral RS block. Ultrasound-guided technique. Using local anesthetics. | Procedure or surgery | QLB + RSB Group |
| Bilateral QLB alonePreoperative regional anesthesia. Isolated bilateral QL block. No rectus sheath block. Ultrasound-guided technique. Using local anesthetics. | Procedure or surgery | QLB Group |
Primary outcome
Postoperative pain intensity
Time frame: At 2, 4, 6, 12, and 24 hours postoperative assessment
Visual Analog Scale (VAS) score. Scale from 0 to 10. 0 means no pain. 10 means worst pain. Lower scores sindicate less pain.
1 secondary outcome
Total opioid consumption. Postoperative period. Measured in milligrams.
Time frame: Within 24 hours after surgery.
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 15 Jul 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared to protect patient privacy. All collected clinical data will remain confidential within the medical center. The study protocol and statistical methods may be available upon direct request.
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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 testing Bilateral QLB and RSB and Bilateral QLB alone in people with Postoperative Pain and Pelvic Pain, run by Medical and Diagnostic Center "MEDION" LLC at 1 site in Ukraine.
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 4 inclusion and 5 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 15 Jul 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 Ukraine. 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 intensity (time frame: At 2, 4, 6, 12, and 24 hours postoperative assessment). 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 15 Jul 2026.