Pain, AcuteNCT05446727
Quadratus Lumborum Block vs Erector Spinal Block for Post Abdomen Surgery Analgesia
A study testing Ropivacaine injection in people with Pain, Acute and Postoperative Pain, run by Jagiellonian University at 1 site in Poland.
Trial summary
Prior to surgery, patients will be stratified into groups according to the type of surgical procedure. The anticipated groups are as follows: Patients with colorectal cancer Patients with prostate cancer Patients with renal cancer Patients undergoing surgery for gallbladder cholelithiasis. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Pain, Acute, Postoperative Pain, Anesthetics, Local
- What is being tested?
- Ropivacaine injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 sitePoland
- Study dates
- 1 May 2022to 31 Dec 2023
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients requiring abdomen surgery
- Patients of age 18 and over
- BMI < 40
- Patients who are expected to stay in-hospital overnight after surgery
Who cannot join
- Patient refusal
- Contraindications to paravertebral blocks: Infection at the site of needle insertion, empyema, allergy to local anesthetic drugs, and tumor occupying the thoracic paravertebral space, coagulopathy, bleeding disorder or therapeutic anticoagulation
- Known allergy to local anesthetics
- Inability to provide informed consent
- Inability to use a PCA due to languate or comprehension barriers
- BMI >= 40
- Any patient on opioids for greater than or equal to 3 months duration prior to surgery
- Patients with chronic pain syndromes
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Quadratus Lumborum Block Versus Erector Spinal Block - Comparison of the Effectiveness of the Analgesic Effect in Patients After Abdominal Surgery
Prior to surgery, patients will be stratified into groups according to the type of surgical procedure. The anticipated groups are as follows:
Patients with colorectal cancer
Read more
Patients with prostate cancer
Patients with renal cancer
Patients undergoing surgery for gallbladder cholelithiasis. The Erector Spinal Block (ESP) is based on the deposition of the local anesthetic in the inter-fascial space between the dorsal extensor muscle and the intercostal muscles at the height of the transverse processes. The scope of the blockade covers the dorsal and ventral branches of the thoracic spinal nerves, but also in most cases the investigetors are able to obtain a wide distribution of the drug into the paravertebral space by "permeating" the local anesthetic through the fascial compartments. The clinical effect of the blockade is due to blocking the nerve structures of the paravertebral space (spinal nerve branches and the sympathetic trunk). The scope of the blockade, after its execution at the level of Th5, most often includes the segments from Th1 to L1.
Currently, the Quadratus Lumborum block (QL block) is performed as one of the perioperative pain management procedures for all generations (pediatrics, pregnant, and adult) undergoing abdominal surgery. The local anesthetic injected via the approach of the anterior QL block ( QL1 block ) can more easily extend beyond the TAP to the thoracic paravertebral space or the thoracolumbar plane, the posterior QL block entails a broader sensory-level analgesic and may generate analgesia from T7 to L1.
Read the detailed description
In abdomen surgery, overall pain is a conglomerate of three different and clinically separate components: incisional pain (somatic pain), visceral pain (deep intra abdominal pain), and shoulder pain due to peritoneal stretching and diaphragmatic irritation associated with carbon dioxide insufflation. Moreover, it has been hypothesized that intense acute pain after labdomen surgery may predict development of chronic pain. Without effective treatment, this ongoing pain may delay recovery, mandate inpatient admission, and thereby increase the cost of such care.
- Conditions
- Pain, Acute, Postoperative Pain, Anesthetics, Local
- Being tested
- Ropivacaine injection
- Keywords
- Anesthetics, Local Anesthetics
- Medical subject headings
- Acute Pain, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ropivacaine injectionDrug
30ml of 0.35% ropivacaine bilaterally
| Study group | Role | What they receive |
|---|---|---|
| Quadratus Lumborum block group | Experimental | Experimental: Quadratus Lumborum block group Patients were placed in the lateral decubitus position. After skin disinfection, a linear high-frequency ultrasound probe guarded with a sterile cover was set above the iliac crest and shifted cranially until the three abdominal wall muscles were distinguished. Then, it was moved medially until latissimus dorsi and quadratus lumborum (QLM) muscles were shown within identical short-axis views. A 21-gauge needle was inserted from the edge of the probe using an in-plane technique and advanced into the fascia over the QLM. After ensuring negative aspiration for blood, 30 ml of 0.35% ropivacaine bilateral was injected slowly into the fascial interspace. Receives: Drug: Ropivacaine injection |
| erector spinae planae block | Experimental | The ESP block was performed with the patient in a sitting position. After skin disinfection, a linear high-frequency (L14-6NS) ultrasound probe, covered with a sterile sheath, was positioned sagittally 1-2 cm lateral to the midline at the level of the ninth thoracic vertebra (T9). The T9 level was earlier identified by palpating the spinous process of the seventh cervical vertebra and counting down nine intervertebral spaces. After identifying the erector spinae muscle (ESM) and transverse process, a 21-gauge needle was inserted deep into the ESM in a cranio-caudal direction, using an in-plane technique. The needle was advanced, ensuring that it crossed all muscle layers until it contacted the transverse process. A total of 60 mL of 0.35% ropivacaine was given. This procedure was performed bilaterally on each patient. Receives: Drug: Ropivacaine injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total long acting opioid consumption in oxycodone equivalents
the total dosage of given drug
Measured: 1 days
Secondary outcomes (2)
Pain scores will be recorded at intervals. The Numerical Rating Scale (NRS) is an 11-point scale where 0 is no pain and 10 is the worst pain imaginable.
The patients will be asked about level of pain every 2 hours
Measured: 1 days
Incidence of postoperative nausea-vomiting; itching; local anesthetic toxicity;
The patients will be asked about Incidence of postoperative nausea-vomiting; itching; local anesthetic toxicity.
Measured: 1vdays
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2022
- Study start1 May 2022
- Primary completion6 May 2022
- Study completion31 Dec 2023
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 Pain, AcuteStudies 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jagiellonian University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tomasz Skladzien, Jagiellonian University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05446727
- Sponsor's protocol ID
- 1072.6120.32.2022
- Status last verified
- Jun 2023
- First submitted
- 2 Jun 2022
- Last updated
- 4 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tomasz S, Pawel M, Michal C, Szpunar W, Jan S, Tomasz L, Anna K, Renata B, Olga S, Tomasz D, Michal T. Effects of Erector Spinae Plane Block and Quadratus Lumborum Block on Postoperative Opioid Consumption in Laparoscopic Kidney Surgery: A Randomized Controlled Clinical Trial. Pain Res Manag. 2025 Aug 4;2025:8869716. doi: 10.1155/prm/8869716. eCollection 2025.
PubMed 40791636
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quadratus Lumborum Block Versus Erector Spinal Block - Comparison of the Effectiveness of the Analgesic Effect in Patients After Abdominal Surgery
- ClinicalTrials.gov ID
- NCT05446727
- Acronym / sponsor ID
- 1072.6120.32.2022
- Conditions
- Pain, Acute, Postoperative Pain, Anesthetics, Local
- Keywords
- Anesthetics, Local Anesthetics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Jagiellonian UniversityUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 6 May 2022 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 7 Jul 2022 (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.
Prior to surgery, patients will be stratified into groups according to the type of surgical procedure. The anticipated groups are as follows:
Patients with colorectal cancer
Patients with prostate cancer
Patients with renal cancer
Patients undergoing surgery for gallbladder cholelithiasis. The Erector Spinal Block (ESP) is based on the deposition of the local anesthetic in the inter-fascial space between the dorsal extensor muscle and the intercostal muscles at the height of the transverse processes. The scope of the blockade covers the dorsal and ventral branches of the thoracic spinal nerves, but also in most cases the investigetors are able to obtain a wide distribution of the drug into the paravertebral space by "permeating" the local anesthetic through the fascial compartments. The clinical effect of the blockade is due to blocking the nerve structures of the paravertebral space (spinal nerve branches and the sympathetic trunk). The scope of the blockade, after its execution at the level of Th5, most often includes the segments from Th1 to L1.
Currently, the Quadratus Lumborum block (QL block) is performed as one of the perioperative pain management procedures for all generations (pediatrics, pregnant, and adult) undergoing abdominal surgery. The local anesthetic injected via the approach of the anterior QL block ( QL1 block ) can more easily extend beyond the TAP to the thoracic paravertebral space or the thoracolumbar plane, the posterior QL block entails a broader sensory-level analgesic and may generate analgesia from T7 to L1.
Detailed description
In abdomen surgery, overall pain is a conglomerate of three different and clinically separate components: incisional pain (somatic pain), visceral pain (deep intra abdominal pain), and shoulder pain due to peritoneal stretching and diaphragmatic irritation associated with carbon dioxide insufflation. Moreover, it has been hypothesized that intense acute pain after labdomen surgery may predict development of chronic pain. Without effective treatment, this ongoing pain may delay recovery, mandate inpatient admission, and thereby increase the cost of such care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Quadratus Lumborum block group | Experimental | Drug: Ropivacaine injectionExperimental: Quadratus Lumborum block group Patients were placed in the lateral decubitus position. After skin disinfection, a linear high-frequency ultrasound probe guarded with a sterile cover was set above the iliac crest and shifted cranially until the three abdominal wall muscles were distinguished. Then, it was moved medially until latissimus dorsi and quadratus lumborum (QLM) muscles were shown within identical short-axis views. A 21-gauge needle was inserted from the edge of the probe using an in-plane technique and advanced into the fascia over the QLM. After ensuring negative aspiration for blood, 30 ml of 0.35% ropivacaine bilateral was injected slowly into the fascial interspace. |
| erector spinae planae block | Experimental | Drug: Ropivacaine injectionThe ESP block was performed with the patient in a sitting position. After skin disinfection, a linear high-frequency (L14-6NS) ultrasound probe, covered with a sterile sheath, was positioned sagittally 1-2 cm lateral to the midline at the level of the ninth thoracic vertebra (T9). The T9 level was earlier identified by palpating the spinous process of the seventh cervical vertebra and counting down nine intervertebral spaces. After identifying the erector spinae muscle (ESM) and transverse process, a 21-gauge needle was inserted deep into the ESM in a cranio-caudal direction, using an in-plane technique. The needle was advanced, ensuring that it crossed all muscle layers until it contacted the transverse process. A total of 60 mL of 0.35% ropivacaine was given. This procedure was performed bilaterally on each patient. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients requiring abdomen surgery
- Patients of age 18 and over
- BMI < 40
- Patients who are expected to stay in-hospital overnight after surgery
Key exclusion criteria (8 listed)
- Patient refusal
- Contraindications to paravertebral blocks: Infection at the site of needle insertion, empyema, allergy to local anesthetic drugs, and tumor occupying the thoracic paravertebral space, coagulopathy, bleeding disorder or therapeutic anticoagulation
- Known allergy to local anesthetics
- Inability to provide informed consent
- Inability to use a PCA due to languate or comprehension barriers
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 |
|---|---|---|
| Ropivacaine injection30ml of 0.35% ropivacaine bilaterally | Drug | Quadratus Lumborum block group, erector spinae planae block |
Primary outcome
Total long acting opioid consumption in oxycodone equivalents
Time frame: 1 days
the total dosage of given drug
2 secondary outcomes
Pain scores will be recorded at intervals. The Numerical Rating Scale (NRS) is an 11-point scale where 0 is no pain and 10 is the worst pain imaginable.
Time frame: 1 days
Incidence of postoperative nausea-vomiting; itching; local anesthetic toxicity;
Time frame: 1vdays
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 4 Sep 2025.
- Derived from this study: PubMed 40791636Tomasz S, Pawel M, Michal C, Szpunar W, Jan S, Tomasz L, Anna K, Renata B, Olga S, Tomasz D, Michal T. Effects of Erector Spinae Plane Block and Quadratus Lumborum Block on Postoperative Opioid Consumption in Laparoscopic Kidney Surgery: A Randomized Controlled Clinical Trial. Pain Res Manag. 2025 Aug 4;2025:8869716. doi: 10.1155/prm/8869716. eCollection 2025.
- Individual participant dataSharing planned: No
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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 Ropivacaine injection in people with Pain, Acute and Postoperative Pain, run by Jagiellonian University at 1 site in Poland.
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 8 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 4 Sep 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 Poland. 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?
Total long acting opioid consumption in oxycodone equivalents (time frame: 1 days). 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 NCT05446727, 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 4 Sep 2025.