Postoperative PainGYNQLBFPBNCT07114965
Effects Of Quadratus Lumborum Type 1 Block And Transversalis Facial Plane Block On Acute Pain In Gynecological Surgery
An observational study of Postoperative Pain and Gynecologic Surgery, run by Ankara Diskapi Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
This study was conducted to evaluate the effectiveness of Quadratus Lumborum Type 1 and Transversalis Fascial Plane blocks on postoperative acute pain in gynecology operations. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Postoperative Pain, Gynecologic Surgery
- How many people
- 68 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2025to 1 Aug 2025
- How long will I take part?
- 1 Day
- Phase
- Observational
- 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 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women who have undergone open gynecological surgery
Who may be able to join
- ASA I-III
- 18-80 years old women's medicines
- Open myomectomy and total abdominal hysterectomy cases
Who cannot join
- Those who do not want a block
- Patients who are allergic to local anesthetics
- Patients with coagulopathy ·
- Pregnancy
- Previous surgery in the area where the block will be applied
Trial locations and contacts
1 site in 1 country.
About this study
This study was conducted to evaluate the effectiveness of Quadratus Lumborum Type 1 and Transversalis Fascial Plane blocks on postoperative acute pain in gynecology operations.
Read the detailed description
In gynecological operations, especially total abdominal hysterectomy, moderate to severe postoperative pain is usually accompanied. Inadequately treated postoperative abdominal hysterectomy pain causes delayed postoperative recovery, prolonged hospital stay, chronic pain, increased chance of venous thrombosis and patient dissatisfaction. Multimodal analgesia techniques are widely used, but new evidence has shown that combinations with regional anesthesia techniques are the most effective method in postoperative pain treatment. Opioids continue to be the main step in postoperative pain treatment, despite strong evidence of their disadvantages. Opioid administration in acute postoperative pain is associated with many side effects such as sedation, pruritus, nausea and vomiting. Regional analgesia techniques used to reduce the amount of opioid used and provide effective analgesia are becoming an integral part of postoperative opioid-sparing analgesia. Open surgeries increase tissue trauma and increase inflammatory response due to high surgical stress. The reduction of pain by regional analgesia application facilitates postoperative mobilization and reduces complications. Abdominal wall blocks are performed on the principle of high-volume local anesthetic deposition within a fascial plane. Ultrasound-guided performance with continuous visualization of the needle improves placement accuracy and reduces inadvertent visceral or neurovascular injury. Abdominal wall blocks primarily provide somatic analgesia, but newer blocks can also block visceral nerves. Abdominal wall blocks provide a relatively safe alternative to epidural analgesia without the risk of motor block, hypotension, or central neuraxis. The quadratus lumborum fascial block (QLB), recently described by Blanco and modified by Sauter et al, is considered an extension of the TAP block. A local anesthetic is injected adjacent to the QL muscle, which aims to anesthetize the thoracolumbar nerves. The QL muscle is a quadrangular-shaped posterior abdominal wall muscle that inserts inferiorly on the iliac crest, cranially on the 12th rib, medially on the transverse processes of L1 to L4, and has a free lateral margin. The QL muscle is related to the PM muscle on its anterior surface and to the spinal erector muscle group on its posterior surface. The muscle is surrounded by the thoracolumbar fascia. Three techniques for QLB have been described and named according to the position of the needle tip in relation to the QL muscle: QLB type 1 or lateral; type 2 or posterior; and transmuscular, or anterior. Many case reports and randomized trials have included analgesia for gynecologic and lower abdominal surgery, Pfannenstiel incision for cesarean section, proctosigmoidectomy, hip surgery, abdominal hernioplasty, nephrectomy, and laparotomy as indications. There are several case reports with different indications for QLB for sensory block between T7 and L2. The transversalis fascial plane block is a truncal block that targets the L1 nerve branches, namely the ilioinguinal and iliohypogastric nerves. The ilioinguinal and iliohypogastric nerves originate from the lateral border of the psoas major muscle, below the 12th rib, and run along the anterior surface of the quadratus lumborum muscle. Lateral to the quadratus lumborum muscle, it initially descends deep to the transversus abdominis muscle for a variable distance and penetrates the transversus abdominis muscle to enter the transversus abdominis plane between the internal oblique and transversus abdominis muscles. This block is also an analgesic option for inguinal hernia repair, open appendectomy, and any surgical procedure involving the L1 dermatome. In this study, the investigators will evaluate the effectiveness of quadratus lumborum and transversalis fascial plane blocks, which are abdominal wall blocks, on postoperative acute pain in open gynecological operations.
- Conditions
- Postoperative Pain, Gynecologic Surgery
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| open gynecological operations | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain between groups
The steps of expanding the transversalis fascial plane in acute pain are being investigated against the quadratus lumborum 1 spread applied in gynecological surgery.
Measured: day 1
Secondary outcomes (2)
Time to first rescue analgesic consumption
To investigate the effects of transversalis fascial plane block versus quadratus lumborum 1 block on the recovery time and the time to first postoperative analgesic consumption in patients undergoing gynecological surgery.
Measured: day 1
total opioid consumption
Monitoring of total opioid consumption for 24 hours postoperatively
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2025
- Study start1 Jun 2025
- Primary completion1 Jul 2025
- Study completion1 Aug 2025 (estimated)
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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 68 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Ankara Diskapi Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ilkay baran akkuş, Ankara Diskapi Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07114965
- Sponsor's protocol ID
- AEŞH-EK-2025-151
- Acronym
- GYNQLBFPB
- Status last verified
- Aug 2025
- First submitted
- 6 Jul 2025
- Last updated
- 11 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects Of Quadratus Lumborum Type 1 Block And Transversalis Facial Plane Block On Acute Pain In Gynecological Surgery
- ClinicalTrials.gov ID
- NCT07114965
- Acronym / sponsor ID
- GYNQLBFPB / AEŞH-EK-2025-151
- Conditions
- Postoperative Pain, Gynecologic Surgery
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Ankara Diskapi Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 1 Jul 2025 (actual)
- Study completion
- 1 Aug 2025 (estimated)
- First posted
- 11 Aug 2025 (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.
This study was conducted to evaluate the effectiveness of Quadratus Lumborum Type 1 and Transversalis Fascial Plane blocks on postoperative acute pain in gynecology operations.
Detailed description
In gynecological operations, especially total abdominal hysterectomy, moderate to severe postoperative pain is usually accompanied. Inadequately treated postoperative abdominal hysterectomy pain causes delayed postoperative recovery, prolonged hospital stay, chronic pain, increased chance of venous thrombosis and patient dissatisfaction. Multimodal analgesia techniques are widely used, but new evidence has shown that combinations with regional anesthesia techniques are the most effective method in postoperative pain treatment. Opioids continue to be the main step in postoperative pain treatment, despite strong evidence of their disadvantages. Opioid administration in acute postoperative pain is associated with many side effects such as sedation, pruritus, nausea and vomiting. Regional analgesia techniques used to reduce the amount of opioid used and provide effective analgesia are becoming an integral part of postoperative opioid-sparing analgesia. Open surgeries increase tissue trauma and increase inflammatory response due to high surgical stress. The reduction of pain by regional analgesia application facilitates postoperative mobilization and reduces complications. Abdominal wall blocks are performed on the principle of high-volume local anesthetic deposition within a fascial plane. Ultrasound-guided performance with continuous visualization of the needle improves placement accuracy and reduces inadvertent visceral or neurovascular injury. Abdominal wall blocks primarily provide somatic analgesia, but newer blocks can also block visceral nerves. Abdominal wall blocks provide a relatively safe alternative to epidural analgesia without the risk of motor block, hypotension, or central neuraxis. The quadratus lumborum fascial block (QLB), recently described by Blanco and modified by Sauter et al, is considered an extension of the TAP block. A local anesthetic is injected adjacent to the QL muscle, which aims to anesthetize the thoracolumbar nerves. The QL muscle is a quadrangular-shaped posterior abdominal wall muscle that inserts inferiorly on the iliac crest, cranially on the 12th rib, medially on the transverse processes of L1 to L4, and has a free lateral margin. The QL muscle is related to the PM muscle on its anterior surface and to the spinal erector muscle group on its posterior surface. The muscle is surrounded by the thoracolumbar fascia. Three techniques for QLB have been described and named according to the position of the needle tip in relation to the QL muscle: QLB type 1 or lateral; type 2 or posterior; and transmuscular, or anterior. Many case reports and randomized trials have included analgesia for gynecologic and lower abdominal surgery, Pfannenstiel incision for cesarean section, proctosigmoidectomy, hip surgery, abdominal hernioplasty, nephrectomy, and laparotomy as indications. There are several case reports with different indications for QLB for sensory block between T7 and L2. The transversalis fascial plane block is a truncal block that targets the L1 nerve branches, namely the ilioinguinal and iliohypogastric nerves. The ilioinguinal and iliohypogastric nerves originate from the lateral border of the psoas major muscle, below the 12th rib, and run along the anterior surface of the quadratus lumborum muscle. Lateral to the quadratus lumborum muscle, it initially descends deep to the transversus abdominis muscle for a variable distance and penetrates the transversus abdominis muscle to enter the transversus abdominis plane between the internal oblique and transversus abdominis muscles. This block is also an analgesic option for inguinal hernia repair, open appendectomy, and any surgical procedure involving the L1 dermatome. In this study, the investigators will evaluate the effectiveness of quadratus lumborum and transversalis fascial plane blocks, which are abdominal wall blocks, on postoperative acute pain in open gynecological operations.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| open gynecological operations | – | – |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women who have undergone open gynecological surgery
Key inclusion criteria (3 listed)
- ASA I-III
- 18-80 years old women's medicines
- Open myomectomy and total abdominal hysterectomy cases
Key exclusion criteria (5 listed)
- Those who do not want a block
- Patients who are allergic to local anesthetics
- Patients with coagulopathy ·
- Pregnancy
- Previous surgery in the area where the block will be applied
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Postoperative pain between groups
Time frame: day 1
The steps of expanding the transversalis fascial plane in acute pain are being investigated against the quadratus lumborum 1 spread applied in gynecological surgery.
2 secondary outcomes
Time to first rescue analgesic consumption
Time frame: day 1
total opioid consumption
Time frame: day 1
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 11 Aug 2025.
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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?
An observational study of Postoperative Pain and Gynecologic Surgery, run by Ankara Diskapi Training and Research Hospital at 1 site in Turkey (Türkiye).
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 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: under way, not looking for participants, as of the sponsor's last update on 11 Aug 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 Turkey (Türkiye). 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?
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 between groups (time frame: day 1). 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 11 Aug 2025.