Postoperative PainNCT07901829
Comparison of the Ultrasound Guided Effects of the Erector Spina Plane Block and Quadratus Lumborum Block Methods on Postoperative Analgesia and Plasma Cytokine Levels in Elective Cesarean Operations
A study testing QL (quadratus lumborum) block and Erector Spinae Plane Block in people with Postoperative Pain and IL-1 Beta, run by Sanliurfa Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Comparison of Two Different Analgesic Techniques for Reducing Postoperative Pain After Cesarean Section Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postoperative Pain, IL-1 Beta
- What is being tested?
- QL (quadratus lumborum) block and Erector Spinae Plane Block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 29 Mar 2021to 29 Mar 2022
- 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Pregnant women aged 18-45
- Elective cases
- ASA II patients
- Cases in which a cesarean section is planned under spinal anesthesia
- Patients with no contraindications for QLB and ESPB
- Patients who have provided written and verbal consent to participate in the study
Who cannot join
- Pregnant women under 18 or over 45 years of age
- Emergency cases
- Patients who do not wish to participate in the study
- Patients with any contraindications for the QLB and ESPB procedures
- Cases scheduled for cesarean section under general anesthesia
- Patients who are not oriented or cooperative
Show all 9Show fewer
- Patients with renal failure
- Patients with hepatic failure
- Patients in ASA classes III, IV, or V
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Sanliurfa Education and Research Hospital
Sanliurfa, Şanliurfa, 63200
About this study
Comparison of Two Different Analgesic Techniques for Reducing Postoperative Pain After Cesarean Section
Read the detailed description
The control of postoperative pain following cesarean section is of great importance in terms of patient comfort. Effective analgesia plays a crucial role in promoting mother-infant bonding, facilitating early breastfeeding, and enabling early mobilization of the patient. A multidisciplinary approach involving the anesthesiology and obstetrics departments, together with the implementation of a standardized protocol, may improve the effectiveness of pain management. Although opioids administered systemically or neuraxially are effective in providing analgesia, their use may be limited by significant adverse effects, including nausea, vomiting, constipation, and respiratory depression.
Following cesarean section, both somatic pain originating from the abdominal wall incision and visceral pain associated with the uterus may occur. Most of the distressing postoperative pain is of somatic origin, arising from the abdominal wall. The transversus abdominis plane (TAP) is a fascial plane located between the internal oblique and transversus abdominis muscles, containing the thoracolumbar nerves from T10 to L1 . Therefore, the administration of local anesthetics into this fascial plane results in the blockade of the nerves supplying the abdominal wall. The TAP block has gained increasing popularity in recent years and has become an integral component of multimodal pain management in abdominal surgical procedures, including cesarean section, hysterectomy, cholecystectomy, and appendectomy .
The erector spinae plane (ESP) block is an interfascial plane block performed in the paraspinal region. It allows the injected local anesthetic to spread cranially and caudally across three to four vertebral levels, providing effective somatic and visceral analgesia .
The aim of this study was to compare the efficacy of bilateral erector spinae plane (ESP) block and bilateral transversus abdominis plane (TAP) block for postoperative analgesia in patients scheduled for cesarean section under spinal anesthesia.
- Conditions
- Postoperative Pain, IL-1 Beta
- Being tested
- QL (quadratus lumborum) block, Erector Spinae Plane Block, Control
- Keywords
- ceserenan section, postoperative pain, patient-controlled analgesia, quadratus lumborum block, erector spinae plane block
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QL (quadratus lumborum) blockProcedure or surgery
In the QLB group, a bilateral block was performed under ultrasound (US) guidance using a mixture of 0.25% bupivacaine and 0.5% lidocaine (20 mL) postoperatively.
Erector Spinae Plane BlockProcedure or surgery
In the ESPB group, a bilateral block was performed under ultrasound (US) guidance using a mixture of 0.25% bupivacaine and 0.5% lidocaine (20 mL) postoperatively.
ControlProcedure or surgery
NO BLOCK WAS CREATED.
| Study group | Role | What they receive |
|---|---|---|
| QUADRATUS LUMBORUM BLOCK | Experimental | patient receive block that QUADRATUS LUMBORUM BLOCK Receives: Procedure: QL (quadratus lumborum) block |
| ERECTOR SPİNA PLAN BLOCK | Experimental | patient receive block ERECTOR SPİNA PLAN BLOCK Receives: Procedure: Erector Spinae Plane Block |
| CONTROL | Experimental | No block was performed. Receives: Procedure: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Acute Pain Scores
Postoperative acute pain scores assingment with Visual Analog Scores
Measured: postoperative T1: 0. hours, T2:4.hours,T3: 24.hours
Secondary outcomes (3)
Total Opioid Consumption
We plan to investigate the effects of the quadrates lumborum plan block and the erector spina plane block on opioid consumption in patients undergoing cesarean section surgery.
Measured: postoperative T1: 0. hours, T2:4.hours,T3: 24.hours
PATIENT SATISFACTION (Likert Scale) Not satisfied at all 1 Slightly satisfied 2 Moderately satisfied3 Satisfied4 Excellent5 SURGEON SATISFACTION (Likert Scale) Not satisfied at all 1 Slightly satisfied 2 Moderately satisfied3 Satisfied4 Excellent5
Secondary outcomes will include patient- and surgeon-based Likert scale assessments.
Measured: postoperative T1: 0. hours, T2:4.hours,T3: 24.hours
Amino acid changes associated with pain were examined
Venous blood samples were collected from patients at 0, 4, and 24 hours postoperatively, and plasma cytokine and amino acid (AA) levels were measured.
Measured: postoperative T1: 0. hours, T2:4.hours,T3: 24.hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2026
- Study start29 Mar 2021
- Primary completion29 Mar 2022
- Study completion29 Mar 2022
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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanliurfa Education and Research Hospital
- Sponsor type
- Other government
- Collaborators
- Harran University
- Responsible party
- Principal investigator, MELİKE BOSTANCI ERKMEN, Sanliurfa Education and Research Hospital
- Investigators
- MELİKE BOSTANCI ERKMEN, MD, Principal investigator, HARRAN UNIVERSİTYMAHMUT ALP KARAHAN, PROFESSOR, PH.D., Study director, HARRAN UNİVERSİTYMELİKE BOSTANCI ERKMEN, MD, Principal investigator, HARRAN UNİVERSİTY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07901829
- Sponsor's protocol ID
- MERKMENTEZ
- Status last verified
- Mar 2021
- First submitted
- 21 Oct 2026
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No Ethics committee approval covers only aggregate data analysis; there is no permission to share individual participant data.
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Ultrasound Guided Effects of the Erector Spina Plane Block and Quadratus Lumborum Block Methods on Postoperative Analgesia and Plasma Cytokine Levels in Elective Cesarean Operations
- ClinicalTrials.gov ID
- NCT07901829
- Acronym / sponsor ID
- MERKMENTEZ
- Conditions
- Postoperative Pain, IL-1 Beta
- Keywords
- ceserenan section, postoperative pain, patient-controlled analgesia, quadratus lumborum block, erector spinae plane block
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Sanliurfa Education and Research HospitalOther government
- Collaborators
- Harran University
- Study start
- 29 Mar 2021 (actual)
- Primary completion
- 29 Mar 2022 (actual)
- Study completion
- 29 Mar 2022 (actual)
- First posted
- 28 Oct 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.
Comparison of Two Different Analgesic Techniques for Reducing Postoperative Pain After Cesarean Section
Detailed description
The control of postoperative pain following cesarean section is of great importance in terms of patient comfort. Effective analgesia plays a crucial role in promoting mother-infant bonding, facilitating early breastfeeding, and enabling early mobilization of the patient. A multidisciplinary approach involving the anesthesiology and obstetrics departments, together with the implementation of a standardized protocol, may improve the effectiveness of pain management. Although opioids administered systemically or neuraxially are effective in providing analgesia, their use may be limited by significant adverse effects, including nausea, vomiting, constipation, and respiratory depression.
Following cesarean section, both somatic pain originating from the abdominal wall incision and visceral pain associated with the uterus may occur. Most of the distressing postoperative pain is of somatic origin, arising from the abdominal wall. The transversus abdominis plane (TAP) is a fascial plane located between the internal oblique and transversus abdominis muscles, containing the thoracolumbar nerves from T10 to L1 . Therefore, the administration of local anesthetics into this fascial plane results in the blockade of the nerves supplying the abdominal wall. The TAP block has gained increasing popularity in recent years and has become an integral component of multimodal pain management in abdominal surgical procedures, including cesarean section, hysterectomy, cholecystectomy, and appendectomy .
The erector spinae plane (ESP) block is an interfascial plane block performed in the paraspinal region. It allows the injected local anesthetic to spread cranially and caudally across three to four vertebral levels, providing effective somatic and visceral analgesia .
The aim of this study was to compare the efficacy of bilateral erector spinae plane (ESP) block and bilateral transversus abdominis plane (TAP) block for postoperative analgesia in patients scheduled for cesarean section under spinal anesthesia.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| QUADRATUS LUMBORUM BLOCK | Experimental | Procedure: QL (quadratus lumborum) blockpatient receive block that QUADRATUS LUMBORUM BLOCK |
| ERECTOR SPİNA PLAN BLOCK | Experimental | Procedure: Erector Spinae Plane Blockpatient receive block ERECTOR SPİNA PLAN BLOCK |
| CONTROL | Experimental | Procedure: ControlNo block was performed. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Pregnant women aged 18-45
- Elective cases
- ASA II patients
- Cases in which a cesarean section is planned under spinal anesthesia
- Patients with no contraindications for QLB and ESPB
Key exclusion criteria (9 listed)
- Pregnant women under 18 or over 45 years of age
- Emergency cases
- Patients who do not wish to participate in the study
- Patients with any contraindications for the QLB and ESPB procedures
- Cases scheduled for cesarean section under general anesthesia
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 |
|---|---|---|
| QL (quadratus lumborum) blockIn the QLB group, a bilateral block was performed under ultrasound (US) guidance using a mixture of 0.25% bupivacaine and 0.5% lidocaine (20 mL) postoperatively. | Procedure or surgery | QUADRATUS LUMBORUM BLOCK |
| Erector Spinae Plane BlockIn the ESPB group, a bilateral block was performed under ultrasound (US) guidance using a mixture of 0.25% bupivacaine and 0.5% lidocaine (20 mL) postoperatively. | Procedure or surgery | ERECTOR SPİNA PLAN BLOCK |
| ControlNO BLOCK WAS CREATED. | Procedure or surgery | CONTROL |
Primary outcome
Postoperative Acute Pain Scores
Time frame: postoperative T1: 0. hours, T2:4.hours,T3: 24.hours
Postoperative acute pain scores assingment with Visual Analog Scores
3 secondary outcomes
Total Opioid Consumption
Time frame: postoperative T1: 0. hours, T2:4.hours,T3: 24.hours
PATIENT SATISFACTION (Likert Scale) Not satisfied at all 1 Slightly satisfied 2 Moderately satisfied3 Satisfied4 Excellent5 SURGEON SATISFACTION (Likert Scale) Not satisfied at all 1 Slightly satisfied 2 Moderately satisfied3 Satisfied4 Excellent5
Time frame: postoperative T1: 0. hours, T2:4.hours,T3: 24.hours
Amino acid changes associated with pain were examined
Time frame: postoperative T1: 0. hours, T2:4.hours,T3: 24.hours
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 28 Oct 2026.
- Individual participant dataSharing planned: No. No Ethics committee approval covers only aggregate data analysis; there is no permission to share individual participant data.
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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.
MELİKE BOSTANCI ERKMEN, MD principal investigator
HARRAN UNIVERSİTY
MAHMUT ALP KARAHAN, PROFESSOR, PH.D. study director
HARRAN UNİVERSİTY
MELİKE BOSTANCI ERKMEN, MD principal investigator
HARRAN UNİVERSİTY
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing QL (quadratus lumborum) block and Erector Spinae Plane Block in people with Postoperative Pain and IL-1 Beta, run by Sanliurfa Education 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 6 inclusion and 9 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 28 Oct 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 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?
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 Acute Pain Scores (time frame: postoperative T1: 0. hours, T2:4.hours,T3: 24.hours). 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 28 Oct 2026.