Cesarean SectionPhase 4NCT03404908
TAP vs QLB in Patients After Cesarean Delivery
A Phase 4 study testing TAP (transversus abdominis plane block), QL (quadratus lumborum block) and Ropivacaine in people with Cesarean Section and Postoperative Pain, run by Medical University of Lublin at 1 site in Poland.
Trial summary
Comparison of two types of analgesia after cesarean section All patients will be anesthetized with spinal technique. Ultrasound-guided transversus abdominis plane or quadratus lumborum block to treat postoperative pain. Postoperative pain will be measured with visual-analog scale (VAS). Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Cesarean Section, Postoperative Pain
- What is being tested?
- TAP (transversus abdominis plane block), QL (quadratus lumborum block) and Ropivacaine
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 sitePoland
- Study dates
- 7 Feb 2018to 17 Apr 2019
- Phase
- Phase 4
- 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 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- obtained consent
- singleton pregnancy
- subarachnoid anesthesia
Who cannot join
- coagulopathy
- allergy to local anesthetics
- depression, antidepressant drugs treatment
- epilepsy
- usage of painkiller before surgery
- addiction to alcohol or recreational drugs
Trial locations and contacts
1 site in 1 country.
Poland1 site
II Department of Anesthesia and Intensive Care, Medical University of Lublin
Lublin, 20-081
About this study
Official title: Postoperative Analgesia With Transversus Abdominis Plane Block or Quadratus Lumborum Block in Patients After Cesarian Delivery
Comparison of two types of analgesia after cesarean section All patients will be anesthetized with spinal technique. Ultrasound-guided transversus abdominis plane or quadratus lumborum block to treat postoperative pain. Postoperative pain will be measured with visual-analog scale (VAS). 1, 2, 6 months after surgery each patient will be called to assess neuropathic pain with Neuropathic Pain Symptom Inventory (NPSI).
Read the detailed description
Written consent will be obtained before the cesarean section. Only subarachnoidally anesthetized patients may participate in the study. Pencil-point spinal needle and bupivacaine (Marcaine Heavy Spinal 0.5 %) will be used.
At the end of surgery ultrasound-guided regional block will be performed. Each patient will be randomly allocated to one of the treated group: transversus abdominis plane block (TAP) or quadratus lumborum (QL). Patients receive 0.2 mL of local anesthetic solution (0.375 % ropivacaine) on each side.
Postoperative pain will be measured with VAS (visual-analog scale) 2, 4, 8, 12 and 24 hours after the end of the operation.
Paracetamol, metamizole, ketoprofen may be given as required. Whenever pain exceeds 40 (VAS) 5 mg of morphine will be given intravenously (maximum two dosages per day).
1, 3, 6 months patients will be called to assess neuropathic pain. Neuropathic Pain Symptom Inventory (NPSI) will be used.
- Conditions
- Cesarean Section, Postoperative Pain
- Being tested
- TAP (transversus abdominis plane block), QL (quadratus lumborum block), Ropivacaine, Needle, paracetamol
- Keywords
- transversus abdominis plane block, quadratus lumborum block, neuropathic pain
- Medical subject headings
- Pain, Postoperative, Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAP (transversus abdominis plane block)Procedure or surgery
the ultrasound-guided regional block of abdominal wall muscles to treat acute postoperative pain. Stimuplex Ultra 360 needle will be used and 0.375% ropivacaine administered (0.2 mL/kg).
QL (quadratus lumborum block)Procedure or surgery
the ultrasound-guided regional block of abdominal wall muscles to treat acute pain, similar to transversus abdominis plane block, but with a distribution of local anesthetic towards paravertebral space. Stimuplex Ultra 360 needle will be used and 0.25% bupivacaine administered (0.2 mL/kg).
RopivacaineDrug
In both groups (TAP\&QLB) 0.375% ropivacaine will be given (0.2 mL/kg)
NeedleDevice
Ultrasound-guided, Stimuplex ultra 360 needle will be used in the study
paracetamolDrug
Intravenous paracetamol will be used (1.0 gram), up to 4 grams per day
metamizoleDrug
Intravenous metamizole will be used (1.0 gram), up to 4 grams per day
KetoprofenDrug
Intravenous ketoprofen will be used (0.1 gram), up to 200 milligrams per day
MorphineDrug
Intravenous morphine (5 mg) will be given when pain exceeds 40 mm in VAS (maximum 2 doses per day)
| Study group | Role | What they receive |
|---|---|---|
| TAP | Experimental | Ultrasound-guided transversus abdominis plane block at the end of cesarean section Receives: Procedure: TAP (transversus abdominis plane block); Drug: Ropivacaine; Device: Needle; Drug: paracetamol; Drug: metamizole; Drug: Ketoprofen; Drug: Morphine |
| QLB | Experimental | Ultrasound-guided quadratus lumborum block at the end of cesarean section Receives: Procedure: QL (quadratus lumborum block); Drug: Ropivacaine; Device: Needle; Drug: paracetamol; Drug: metamizole; Drug: Ketoprofen; Drug: Morphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain
Acute pain measured with VAS (visual-analogue scale). VAS in milimmeters. Minimum value 0, maximum 100. Less better - less severe pain. 0 no pain at all.
Measured: up to 24 hours after the surgery
Secondary outcomes (1)
Neuropathic pain
Neuropathic pain occurrence assessed with Neuropathic Pain Symptom Inventory (NPSI) 10 descriptive variables, each one from 0 to 10. 0 means no pain. 10 very high chance of occurrence of neuropathic pain.
Measured: 6 months from the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2018
- Study start7 Feb 2018
- Primary completion14 Jan 2019
- Study completion17 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cesarean SectionStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Lublin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michał Borys, Medical University of Lublin
- Investigators
- Mirosław Czuczwar, M.D., PhD, Study chair, Medical University of Lublin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03404908
- Sponsor's protocol ID
- KE-0254/238/2017
- Status last verified
- Nov 2023
- First submitted
- 12 Jan 2018
- Last updated
- 24 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Analgesia With Transversus Abdominis Plane Block or Quadratus Lumborum Block in Patients After Cesarian Delivery
- ClinicalTrials.gov ID
- NCT03404908
- Acronym / sponsor ID
- KE-0254/238/2017
- Conditions
- Cesarean Section, Postoperative Pain
- Keywords
- transversus abdominis plane block, quadratus lumborum block, neuropathic pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Medical University of LublinUniversity, hospital or other
- Study start
- 7 Feb 2018 (actual)
- Primary completion
- 14 Jan 2019 (actual)
- Study completion
- 17 Apr 2019 (actual)
- First posted
- 19 Jan 2018 (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 types of analgesia after cesarean section All patients will be anesthetized with spinal technique. Ultrasound-guided transversus abdominis plane or quadratus lumborum block to treat postoperative pain. Postoperative pain will be measured with visual-analog scale (VAS). 1, 2, 6 months after surgery each patient will be called to assess neuropathic pain with Neuropathic Pain Symptom Inventory (NPSI).
Detailed description
Written consent will be obtained before the cesarean section. Only subarachnoidally anesthetized patients may participate in the study. Pencil-point spinal needle and bupivacaine (Marcaine Heavy Spinal 0.5 %) will be used.
At the end of surgery ultrasound-guided regional block will be performed. Each patient will be randomly allocated to one of the treated group: transversus abdominis plane block (TAP) or quadratus lumborum (QL). Patients receive 0.2 mL of local anesthetic solution (0.375 % ropivacaine) on each side.
Postoperative pain will be measured with VAS (visual-analog scale) 2, 4, 8, 12 and 24 hours after the end of the operation.
Paracetamol, metamizole, ketoprofen may be given as required. Whenever pain exceeds 40 (VAS) 5 mg of morphine will be given intravenously (maximum two dosages per day).
1, 3, 6 months patients will be called to assess neuropathic pain. Neuropathic Pain Symptom Inventory (NPSI) will be used.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| TAP | Experimental | Procedure: TAP (transversus abdominis plane block), Drug: Ropivacaine, Device: Needle, Drug: paracetamol, Drug: metamizole, Drug: Ketoprofen, Drug: MorphineUltrasound-guided transversus abdominis plane block at the end of cesarean section |
| QLB | Experimental | Procedure: QL (quadratus lumborum block), Drug: Ropivacaine, Device: Needle, Drug: paracetamol, Drug: metamizole, Drug: Ketoprofen, Drug: MorphineUltrasound-guided quadratus lumborum block at the end of cesarean section |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- obtained consent
- singleton pregnancy
- subarachnoid anesthesia
Key exclusion criteria (6 listed)
- coagulopathy
- allergy to local anesthetics
- depression, antidepressant drugs treatment
- epilepsy
- usage of painkiller before surgery
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 |
|---|---|---|
| TAP (transversus abdominis plane block)the ultrasound-guided regional block of abdominal wall muscles to treat acute postoperative pain. Stimuplex Ultra 360 needle will be used and 0.375% ropivacaine administered (0.2 mL/kg). | Procedure or surgery | TAP |
| QL (quadratus lumborum block)the ultrasound-guided regional block of abdominal wall muscles to treat acute pain, similar to transversus abdominis plane block, but with a distribution of local anesthetic towards paravertebral space. Stimuplex Ultra 360 needle will be used and 0.25% bupivacaine administered (0.2 mL/kg). | Procedure or surgery | QLB |
| RopivacaineIn both groups (TAP\&QLB) 0.375% ropivacaine will be given (0.2 mL/kg) | Drug | QLB, TAP |
| NeedleUltrasound-guided, Stimuplex ultra 360 needle will be used in the study | Device | QLB, TAP |
| paracetamolIntravenous paracetamol will be used (1.0 gram), up to 4 grams per day | Drug | QLB, TAP |
| metamizoleIntravenous metamizole will be used (1.0 gram), up to 4 grams per day | Drug | QLB, TAP |
| KetoprofenIntravenous ketoprofen will be used (0.1 gram), up to 200 milligrams per day | Drug | QLB, TAP |
| MorphineIntravenous morphine (5 mg) will be given when pain exceeds 40 mm in VAS (maximum 2 doses per day) | Drug | QLB, TAP |
Primary outcome
Postoperative pain
Time frame: up to 24 hours after the surgery
Acute pain measured with VAS (visual-analogue scale). VAS in milimmeters. Minimum value 0, maximum 100. Less better - less severe pain. 0 no pain at all.
1 secondary outcome
Neuropathic pain
Time frame: 6 months from the 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 24 Nov 2023.
- 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.
Mirosław Czuczwar, M.D., PhD study chair
Medical University of Lublin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing TAP (transversus abdominis plane block), QL (quadratus lumborum block) and Ropivacaine in people with Cesarean Section and Postoperative Pain, run by Medical University of Lublin 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 3 inclusion and 6 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 24 Nov 2023. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 (time frame: up to 24 hours after the surgery). 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 24 Nov 2023.