Cesarean SectionPhase 4NCT02804126
Comparison of Two Pain-treatment Techniques After Cesarean Section
A Phase 4 study testing TAP (transversus abdominis plane block), QL (quadratus lumborum block) and Bupivacaine in people with Cesarean Section and Pain Management, run by Michał Borys at 1 site in Poland.
Trial summary
Comparison of two types of analgesia after cesarean section. All patients will anaesthetised with spinal technique. Ultrasound-guided transversus abdominis plane or quadratus lumborum block to treat postoperative pain. Postoperative pain will measured with visual-analogue scale (VAS). Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Cesarean Section, Pain Management, Neuropathic Pain
- What is being tested?
- TAP (transversus abdominis plane block), QL (quadratus lumborum block) and Bupivacaine
- 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
- 232 participants
- Where
- 1 sitePoland
- Study dates
- 1 Jun 2017to 31 Jul 2018
- 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 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- obtained consent
- singleton pregnancy
- subarachnoid anaesthesia
Who cannot join
- coagulopathy
- allergy to 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.
About this study
Official title: Effectiveness of Transversus Abdominis Plane Block Versus Quadratus Lumborum Technique in Patients After Cesarean Section
Comparison of two types of analgesia after cesarean section.
All patients will anaesthetised with spinal technique. Ultrasound-guided transversus abdominis plane or quadratus lumborum block to treat postoperative pain. Postoperative pain will measured with visual-analogue 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 anaesthetised 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 (0.25 % bupivacaine) on each side.
Postoperative pain will be measured with VAS (visual-analogue scale) 2, 4, 8, 12 and 24 hours after the end of operation.
Paracetamol, metamizol, 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, Pain Management, Neuropathic Pain
- Being tested
- TAP (transversus abdominis plane block), QL (quadratus lumborum block), Bupivacaine, Needle, Paracetamol
- Keywords
- acute pain, transversus abdominis plane block, quadratus lumborum block, neuropathic pain
- Medical subject headings
- Agnosia, Neuralgia, Acute Pain
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
ultrasound-guided regional block between abdominal wall muscles to treat acute postoperative pain. Stimuplex Ultra 360 needle will be used and 0.25% bupivacaine administered (0.2 mL/kg).
QL (quadratus lumborum block)Procedure or surgery
ultrasound-guided regional block between abdominal wall muscles to treat acute pain, similar to transversus abdominis plane block, but with distribution of local anesthetic towards paravertebral space. Stimuplex Ultra 360 needle will be used and 0.25% bupivacaine administered (0.2 mL/kg).
BupivacaineDrug
In both groups (TAP\&QL) 0.25% bupivacaine 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
MetamizolDrug
Intravenous metamizol 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 (transversus abdominis plane) | Experimental | Ultrasound-guided transversus abdominis plane block at the end of cesarean section Receives: Procedure: TAP (transversus abdominis plane block); Drug: Bupivacaine; Device: Needle; Drug: Paracetamol; Drug: Metamizol; Drug: Ketoprofen; Drug: Morphine |
| QL (quadratus lumborum) | Experimental | Ultrasound-guided quadratus lumborum block at the end of cesarean section Receives: Procedure: QL (quadratus lumborum block); Drug: Bupivacaine; Device: Needle; Drug: Paracetamol; Drug: Metamizol; Drug: Ketoprofen; Drug: Morphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain measured with VAS
Acute pain measured with VAS (visual-analogue scale).
Measured: up to 24 hours after surgery
Secondary outcomes (1)
Neuropathic pain assessed with NPSI
Neuropathic pain occurrence with Neuropathic Pain Symptom Inventory (NPSI)
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 posted17 Jun 2016 (estimated)
- Study start1 Jun 2017
- Primary completion31 Jul 2018
- Study completion31 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 232 participants (actual)
Sponsor and investigators
- Lead sponsor
- Michał Borys
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Michał Borys, Medical University of Lublin
- Investigators
- Miroslaw Czuczwar, MD, PhD, Study chair, II Department of Anesthesiology and Intensive Care Medial University of Lublin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02804126
- Sponsor's protocol ID
- KE-0254/85/2016
- Status last verified
- Nov 2023
- First submitted
- 8 Jun 2016
- Last updated
- 28 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kadam VR. Ultrasound-guided quadratus lumborum block as a postoperative analgesic technique for laparotomy. J Anaesthesiol Clin Pharmacol. 2013 Oct;29(4):550-2. doi: 10.4103/0970-9185.119148.
PubMed 24249997Kadam VR. Ultrasound guided quadratus lumborum block or posterior transversus abdominis plane block catheter infusion as a postoperative analgesic technique for abdominal surgery. J Anaesthesiol Clin Pharmacol. 2015 Jan-Mar;31(1):130-1. doi: 10.4103/0970-9185.150575. No abstract available.
PubMed 25788791Kanazi GE, Aouad MT, Abdallah FW, Khatib MI, Adham AM, Harfoush DW, Siddik-Sayyid SM. The analgesic efficacy of subarachnoid morphine in comparison with ultrasound-guided transversus abdominis plane block after cesarean delivery: a randomized controlled trial. Anesth Analg. 2010 Aug;111(2):475-81. doi: 10.1213/ANE.0b013e3181e30b9f. Epub 2010 May 20.
PubMed 20488929
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Transversus Abdominis Plane Block Versus Quadratus Lumborum Technique in Patients After Cesarean Section
- ClinicalTrials.gov ID
- NCT02804126
- Acronym / sponsor ID
- KE-0254/85/2016
- Conditions
- Cesarean Section, Pain Management, Neuropathic Pain
- Keywords
- acute pain, transversus abdominis plane block, quadratus lumborum block, neuropathic pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 232 participants (actual)
- Lead sponsor
- Michał BorysUniversity, hospital or other
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 31 Jul 2018 (actual)
- Study completion
- 31 Jul 2018 (actual)
- First posted
- 17 Jun 2016 (estimated)
- 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 anaesthetised with spinal technique. Ultrasound-guided transversus abdominis plane or quadratus lumborum block to treat postoperative pain. Postoperative pain will measured with visual-analogue 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 anaesthetised 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 (0.25 % bupivacaine) on each side.
Postoperative pain will be measured with VAS (visual-analogue scale) 2, 4, 8, 12 and 24 hours after the end of operation.
Paracetamol, metamizol, 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
| Arm | Type | Receives |
|---|---|---|
| TAP (transversus abdominis plane) | Experimental | Procedure: TAP (transversus abdominis plane block), Drug: Bupivacaine, Device: Needle, Drug: Paracetamol, Drug: Metamizol, Drug: Ketoprofen, Drug: MorphineUltrasound-guided transversus abdominis plane block at the end of cesarean section |
| QL (quadratus lumborum) | Experimental | Procedure: QL (quadratus lumborum block), Drug: Bupivacaine, Device: Needle, Drug: Paracetamol, Drug: Metamizol, Drug: Ketoprofen, Drug: MorphineUltrasound-guided quadratus lumborum block at the end of cesarean section |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- obtained consent
- singleton pregnancy
- subarachnoid anaesthesia
Key exclusion criteria (6 listed)
- coagulopathy
- allergy to 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)ultrasound-guided regional block between abdominal wall muscles to treat acute postoperative pain. Stimuplex Ultra 360 needle will be used and 0.25% bupivacaine administered (0.2 mL/kg). | Procedure or surgery | TAP (transversus abdominis plane) |
| QL (quadratus lumborum block)ultrasound-guided regional block between abdominal wall muscles to treat acute pain, similar to transversus abdominis plane block, but with 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 | QL (quadratus lumborum) |
| BupivacaineIn both groups (TAP\&QL) 0.25% bupivacaine will be given (0.2 mL/kg) | Drug | QL (quadratus lumborum), TAP (transversus abdominis plane) |
| NeedleUltrasound-guided, Stimuplex ultra 360 needle will be used in the study | Device | QL (quadratus lumborum), TAP (transversus abdominis plane) |
| ParacetamolIntravenous paracetamol will be used (1.0 gram), up to 4 grams per day | Drug | QL (quadratus lumborum), TAP (transversus abdominis plane) |
| MetamizolIntravenous metamizol will be used (1.0 gram), up to 4 grams per day | Drug | QL (quadratus lumborum), TAP (transversus abdominis plane) |
| KetoprofenIntravenous ketoprofen will be used (0.1 gram), up to 200 milligrams per day | Drug | QL (quadratus lumborum), TAP (transversus abdominis plane) |
| MorphineIntravenous morphine (5 mg) will be given when pain exceeds 40 mm in VAS (maximum 2 doses per day) | Drug | QL (quadratus lumborum), TAP (transversus abdominis plane) |
Primary outcome
Postoperative pain measured with VAS
Time frame: up to 24 hours after surgery
Acute pain measured with VAS (visual-analogue scale).
1 secondary outcome
Neuropathic pain assessed with NPSI
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 28 Nov 2023.
- Background: PubMed 24249997Kadam VR. Ultrasound-guided quadratus lumborum block as a postoperative analgesic technique for laparotomy. J Anaesthesiol Clin Pharmacol. 2013 Oct;29(4):550-2. doi: 10.4103/0970-9185.119148.
- Background: PubMed 25788791Kadam VR. Ultrasound guided quadratus lumborum block or posterior transversus abdominis plane block catheter infusion as a postoperative analgesic technique for abdominal surgery. J Anaesthesiol Clin Pharmacol. 2015 Jan-Mar;31(1):130-1. doi: 10.4103/0970-9185.150575. No abstract available.
- Background: PubMed 20488929Kanazi GE, Aouad MT, Abdallah FW, Khatib MI, Adham AM, Harfoush DW, Siddik-Sayyid SM. The analgesic efficacy of subarachnoid morphine in comparison with ultrasound-guided transversus abdominis plane block after cesarean delivery: a randomized controlled trial. Anesth Analg. 2010 Aug;111(2):475-81. doi: 10.1213/ANE.0b013e3181e30b9f. Epub 2010 May 20.
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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.
Miroslaw Czuczwar, MD, PhD study chair
II Department of Anesthesiology and Intensive Care Medial 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 Bupivacaine in people with Cesarean Section and Pain Management, run by Michał Borys 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 28 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 measured with VAS (time frame: up to 24 hours after surgery). 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 NCT02804126, which also lists 3 linked publications.
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 Nov 2023.