Surgery With General AnesthesiaESP QLB TAPNCT07021105
COMPARISON OF PLAIN BLOCKS FOR POSTOPERATIVE PAIN MANAGEMENT IN GYNECOLOGICAL ABDOMINAL SURGERIES
A study testing ESP Plane block, QLB plane block and TAP Block in people with Surgery With General Anesthesia and Gynecologic Surgical Procedures, run by Cukurova University at 1 site in Turkey (Türkiye).
Trial summary
This study compares the effects of transversus abdominis plane (TAP) block, quadratus lumborum block (QLB), and erector spinae plane block (ESP) on postoperative morphine consumption, pain scores, patient satisfaction, and side effects in patients undergoing gynecological abdominal laparotomy surgeries. Read more about this study
- Who is it for?
- Ages 18 to 69 years, women only
- Conditions the study is for
- Surgery With General Anesthesia, Gynecologic Surgical Procedures, Plane Block
- What is being tested?
- ESP Plane block, QLB plane block and TAP Block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 6 Dec 2024to 10 Sep 2025
- Phase
- Interventional
- 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 69 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- aged between 18 and 69 years, with ASA 1-2 score scheduled to undergo major gynecological abdominal surgery
Who cannot join
- ASA score 3 or above, patients younger than 18 or older than 69 years, patients with bleeding disorders or using anticoagulants, patients with a body mass index over 40, patients with known allergies to any drugs used in the study, and patients who could not or did not wish to use Patient-Controlled Analgesia (PCA) device
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: COMPARISON OF ERECTOR SPINAE PLANE BLOCK, QUADRATUS LUMBORUM BLOCK, AND TRANSVERSUS ABDOMINIS PLANE BLOCK IN POSTOPERATIVE PAIN MANAGEMENT IN GYNECOLOGICAL ABDOMINAL SURGERIES
This study compares the effects of transversus abdominis plane (TAP) block, quadratus lumborum block (QLB), and erector spinae plane block (ESP) on postoperative morphine consumption, pain scores, patient satisfaction, and side effects in patients undergoing gynecological abdominal laparotomy surgeries.
Read the detailed description
Patients will be randomly assigned into four groups using a computer-generated randomization method. According to group allocation, patients will receive the following interventions before extubation under ultrasound (US) guidance except control group:
Group E (n=20): Bilateral erector spinae plane (ESP) block will be performed with 40 ml of 0.25% bupivacaine (20 ml on each side) at the T12 level, approximately 3-4 cm laterally from the midline, in the neurofascial plane between the transverse processes and the erector spinae muscle.
Group Q (n=20): Bilateral quadratus lumborum block (QLB) will be performed with 40 ml of 0.25% bupivacaine (20 ml on each side), placed between the psoas major and quadratus lumborum muscles under US guidance, between the iliac crest and the 12th rib.
Group T (n=20): Bilateral transversus abdominis plane (TAP) block will be performed with 40 ml of 0.25% bupivacaine (20 ml on each side) in the neurofascial plane between the internal oblique and transversus abdominis muscles.
Group C (Control group, n=20): No block will be applied, only the standard intravenous patient-controlled analgesia (PCA) protocol will be used.
The primary aim of this study is to assess the morphine consumption in the postoperative period, while secondary aims include pain score, patient satisfaction, the need for rescue analgesia and side effects
- Conditions
- Surgery With General Anesthesia, Gynecologic Surgical Procedures, Plane Block, Postoperative Pain Management
- Being tested
- ESP Plane block, QLB plane block, TAP Block, No intervention
- Keywords
- Gynecologic surgery, Transversus abdominis plane block, Erector spinae plaen block, Quadratus lumborum block, morphine consumption
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ESP Plane blockProcedure or surgery
Group E (n=20): Bilateral erector spinae plane (ESP) block will be performed with 40 ml of 0.25% bupivacaine (20 ml on each side) at the T12 level, approximately 3-4 cm laterally from the midline, in the neurofascial plane between the transverse processes and the erector spinae muscle.
QLB plane blockProcedure or surgery
Group Q (n=20): Bilateral quadratus lumborum block (QLB) will be performed with 40 ml of 0.25% bupivacaine (20 ml on each side), placed between the psoas major and quadratus lumborum muscles under US guidance, between the iliac crest and the 12th rib.
TAP BlockProcedure or surgery
Group T (n=20): Bilateral transversus abdominis plane (TAP) block will be performed with 40 ml of 0.25% bupivacaine (20 ml on each side) in the neurofascial plane between the internal oblique and transversus abdominis muscles.
No interventionOther
Group C (Control group, n=20): No block will be applied, only the standard intravenous patient-controlled analgesia (PCA) protocol will be used.
| Study group | Role | What they receive |
|---|---|---|
| Group E | Active comparator | Group ESP \& QLB, TAP, Control Receives: Procedure: QLB plane block; Procedure: TAP Block; Other: No intervention |
| Group Q | Active comparator | Group QLB \& ESP, TAP, Control Receives: Procedure: ESP Plane block; Procedure: TAP Block; Other: No intervention |
| Group T | Active comparator | Group T \& ESP, QLB, Control Receives: Procedure: ESP Plane block; Procedure: QLB plane block; Other: No intervention |
| Group C | No intervention | Group C \& ESP, QLB, TAP |
What is being measured
The primary outcome is the main question the study is designed to answer.
morphine consumption in the postoperative period
Thus the primary aim of this study was to assess the morphine consumption in the postoperative period
Measured: For postoperative 24 hours
Secondary outcomes (1)
pain score (VAS=0-10), patient satisfaction (0-10), the need for rescue analgesia (mg) and side effects
Secondary outcomes included pain score (VAS=0-10), patient satisfaction (0-10), the need for rescue analgesia (mg) and side effects
Measured: For postoperative 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2025
- Study start6 Dec 2024
- Primary completion11 Aug 2025 (estimated)
- Study completion10 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgery With General AnesthesiaStudies of the same condition, open and under way.
- More trials run by Cukurova UniversityThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Sequential
- Model description
- Patients will be randomly assigned into four groups using a computer-generated randomization method. According to group allocation, patients will receive the following interventions before extubation under ultrasound (US) guidance except control group. Group E (n=20): Bilateral erector spinae plane (ESP) block Group Q (n=20): Bilateral quadratus lumborum block (QLB) Group T (n=20): Bilateral transversus abdominis plane (TAP) block Group C (Control group, n=20): No block will be applied
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cukurova University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hakki Unlugenc, Cukurova University
- Investigators
- Hakkı Ünlügenç, Professör, Study director, Cukurova University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07021105
- Sponsor's protocol ID
- Decision No. 145
- Acronym
- ESP QLB TAP
- Status last verified
- Jun 2025
- First submitted
- 21 May 2025
- Last updated
- 13 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Considering but not decided
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COMPARISON OF ERECTOR SPINAE PLANE BLOCK, QUADRATUS LUMBORUM BLOCK, AND TRANSVERSUS ABDOMINIS PLANE BLOCK IN POSTOPERATIVE PAIN MANAGEMENT IN GYNECOLOGICAL ABDOMINAL SURGERIES
- ClinicalTrials.gov ID
- NCT07021105
- Acronym / sponsor ID
- ESP QLB TAP / Decision No. 145
- Conditions
- Surgery With General Anesthesia, Gynecologic Surgical Procedures, Plane Block, Postoperative Pain Management
- Keywords
- Gynecologic surgery, Transversus abdominis plane block, Erector spinae plaen block, Quadratus lumborum block, morphine consumption
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Cukurova UniversityUniversity, hospital or other
- Study start
- 6 Dec 2024 (actual)
- Primary completion
- 11 Aug 2025 (estimated)
- Study completion
- 10 Sep 2025 (estimated)
- First posted
- 13 Jun 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 compares the effects of transversus abdominis plane (TAP) block, quadratus lumborum block (QLB), and erector spinae plane block (ESP) on postoperative morphine consumption, pain scores, patient satisfaction, and side effects in patients undergoing gynecological abdominal laparotomy surgeries.
Detailed description
Patients will be randomly assigned into four groups using a computer-generated randomization method. According to group allocation, patients will receive the following interventions before extubation under ultrasound (US) guidance except control group:
Group E (n=20): Bilateral erector spinae plane (ESP) block will be performed with 40 ml of 0.25% bupivacaine (20 ml on each side) at the T12 level, approximately 3-4 cm laterally from the midline, in the neurofascial plane between the transverse processes and the erector spinae muscle.
Group Q (n=20): Bilateral quadratus lumborum block (QLB) will be performed with 40 ml of 0.25% bupivacaine (20 ml on each side), placed between the psoas major and quadratus lumborum muscles under US guidance, between the iliac crest and the 12th rib.
Group T (n=20): Bilateral transversus abdominis plane (TAP) block will be performed with 40 ml of 0.25% bupivacaine (20 ml on each side) in the neurofascial plane between the internal oblique and transversus abdominis muscles.
Group C (Control group, n=20): No block will be applied, only the standard intravenous patient-controlled analgesia (PCA) protocol will be used.
The primary aim of this study is to assess the morphine consumption in the postoperative period, while secondary aims include pain score, patient satisfaction, the need for rescue analgesia and side effects
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Single blind (investigator)
- Number of arms
- 4
- Model description
- Patients will be randomly assigned into four groups using a computer-generated randomization method. According to group allocation, patients will receive the following interventions before extubation under ultrasound (US) guidance except control group. Group E (n=20): Bilateral erector spinae plane (ESP) block Group Q (n=20): Bilateral quadratus lumborum block (QLB) Group T (n=20): Bilateral transversus abdominis plane (TAP) block Group C (Control group, n=20): No block will be applied
| Arm | Type | Receives |
|---|---|---|
| Group E | Active comparator | Procedure: QLB plane block, Procedure: TAP Block, Other: No interventionGroup ESP \& QLB, TAP, Control |
| Group Q | Active comparator | Procedure: ESP Plane block, Procedure: TAP Block, Other: No interventionGroup QLB \& ESP, TAP, Control |
| Group T | Active comparator | Procedure: ESP Plane block, Procedure: QLB plane block, Other: No interventionGroup T \& ESP, QLB, Control |
| Group C | No intervention | –Group C \& ESP, QLB, TAP |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- aged between 18 and 69 years, with ASA 1-2 score scheduled to undergo major gynecological abdominal surgery
Key exclusion criteria (1 listed)
- ASA score 3 or above, patients younger than 18 or older than 69 years, patients with bleeding disorders or using anticoagulants, patients with a body mass index over 40, patients with known allergies to any drugs used in the study, and patients who could not or did not wish to use Patient-Controlled Analgesia (PCA) device
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 |
|---|---|---|
| ESP Plane blockGroup E (n=20): Bilateral erector spinae plane (ESP) block will be performed with 40 ml of 0.25% bupivacaine (20 ml on each side) at the T12 level, approximately 3-4 cm laterally from the midline, in the neurofascial plane between the transverse processes and the erector spinae muscle. | Procedure or surgery | Group Q, Group T |
| QLB plane blockGroup Q (n=20): Bilateral quadratus lumborum block (QLB) will be performed with 40 ml of 0.25% bupivacaine (20 ml on each side), placed between the psoas major and quadratus lumborum muscles under US guidance, between the iliac crest and the 12th rib. | Procedure or surgery | Group E, Group T |
| TAP BlockGroup T (n=20): Bilateral transversus abdominis plane (TAP) block will be performed with 40 ml of 0.25% bupivacaine (20 ml on each side) in the neurofascial plane between the internal oblique and transversus abdominis muscles. | Procedure or surgery | Group E, Group Q |
| No interventionGroup C (Control group, n=20): No block will be applied, only the standard intravenous patient-controlled analgesia (PCA) protocol will be used. | Other | Group E, Group Q, Group T |
Primary outcome
morphine consumption in the postoperative period
Time frame: For postoperative 24 hours
Thus the primary aim of this study was to assess the morphine consumption in the postoperative period
1 secondary outcome
pain score (VAS=0-10), patient satisfaction (0-10), the need for rescue analgesia (mg) and side effects
Time frame: For postoperative 24 hours
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 13 Jun 2025.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. Considering but not decided
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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.
Hakkı Ünlügenç, Professör study director
Cukurova University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ESP Plane block, QLB plane block and TAP Block in people with Surgery With General Anesthesia and Gynecologic Surgical Procedures, run by Cukurova University 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 1 inclusion and 1 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: enrolling by invitation, as of the sponsor's last update on 13 Jun 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?
morphine consumption in the postoperative period (time frame: For postoperative 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 13 Jun 2025.