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Cesarean SectionPhase 4NCT03244540

Regional Analgesia After Cesarean Section

A Phase 4 study testing TAP (transversus abdominis plane block), QLB (quadratus lumborum block) and Stimuplex Ultra 360 needle in people with Cesarean Section and Pain, Postoperative, run by Medical University of Lublin at 2 sites in Poland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

All patients will be anaesthetized with spinal technique. Each patient will be treated with intravenous morphine - patient controlled analgesia (PCA). 2 of 3 groups of patients will receive ultrasound-guided transversus abdominis plane or quadratus lumborum block to treat postoperative pain. Read more about this study

Who is it for?
Ages 18 to 75 years, women only
What is being tested?
TAP (transversus abdominis plane block), QLB (quadratus lumborum block) and Stimuplex Ultra 360 needle
Could I receive a placebo?
No, everyone receives an active treatment
How many people
105 participants
Where
2 sitesPoland
Study dates
4 Sep 2017to 30 Aug 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 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 morphine and local anesthetics
  • depression, antidepressant drugs treatment
  • epilepsy
  • usage of painkiller before surgery
  • addiction to alcohol or recreational drugs

Trial locations and contacts

2 sites in 1 country.

Poland2 sites

  • Szpital Specjalistyczny PRO-FAMILIA w Rzeszowie

    Rzeszów, 35-001

  • Szpital Kliniczny Dzieciątka Jezus

    Warsaw, 02-005

Other trials in Poland

About this study

Official title: Efficacy of Regional Analgesia Techniques (Quadratus Lumborum Block and Transversus Abdominis Plane Block) in Acute and Chronic Pain Treatment in Patients After Cesarean Delivery

All patients will be anaesthetized with spinal technique. Each patient will be treated with intravenous morphine - patient controlled analgesia (PCA). 2 of 3 groups of patients will receive ultrasound-guided transversus abdominis plane or quadratus lumborum block to treat postoperative pain. Postoperative pain will measured with visual-analogue scale (VAS). Total morphine consumption and time to the first demand will be noted. 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.

All patients will receive PCA (patient controlled analgesia) pump with morphine (1 mg/mL, 5 minute interval, no loading dose) after transfer to PACU (post-anesthesia care unit). In PACU vital signs will be monitored.

Each patient will be randomly assigned to one of three groups. In the first group of patients no additional regional analgesia will be performed. In the second and the third group, ultrasound-guided transversus abdominis plane or quadratus lumborum block will be done with 0.375 % ropivacaine (0.2 ml per kg 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.

1, 3, 6 months patients will be called to assess neuropathic pain. Neuropathic Pain Symptom Inventory (NPSI) will be used.

Being tested
TAP (transversus abdominis plane block), QLB (quadratus lumborum block), Stimuplex Ultra 360 needle, Ropivacaine, Paracetamol
Keywords
postoperative pain, 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

    ultrasound-guided regional block between abdominal wall muscles to treat acute postoperative pain

  • QLB (quadratus lumborum block)Procedure or surgery

    ultrasound-guided regional block between abdominal wall muscles to treat acute postoperative pain

  • Stimuplex Ultra 360 needleDevice

    ultrasound-guided needle will be used for QLB and TAP and regional blocks

  • RopivacaineDrug

    0.375 % ropivacaine will be administered for both QLB and TAP (0.2 mL per kg on both sides)

  • ParacetamolDrug

    Intravenous paracetamol will be used (1.0 gram), up to 4 grams per day

  • subarachnoid anesthesiaProcedure or surgery

    subarachnoid anesthesia for each patients participating in the study with pencil point needle

  • PCA (patient controlled analgesia)Procedure or surgery

    All patients will receive PCA pump with morphine (1 mg/mL, 5 minute interval, no loading dose) after transfer to PACU (post-anesthesia care unit)

  • 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

  • BupivacaineDrug

    Also called Marcaine

    Subarachnoid anesthesia with spinal bupivacaine (MARCAINE SPINAL 0.5% HEAVY)

Study groups in NCT03244540
Study groupRoleWhat they receive
PCAExperimentalSubarchnoid anesthesia with bupivacaine PCA with morphine in the PACU
Receives: Drug: Paracetamol; Procedure: subarachnoid anesthesia; Procedure: PCA (patient controlled analgesia); Drug: Metamizol; Drug: Ketoprofen; Drug: Bupivacaine
TAPExperimentalSubarchnoid anesthesia with bupivacaine 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 0.375 % ropivacaine administered (0.2 mL/kg) at the and of cesarean section. PCA with morphine in the PACU
Receives: Procedure: TAP (transversus abdominis plane block); Device: Stimuplex Ultra 360 needle; Drug: Ropivacaine; Drug: Paracetamol; Procedure: subarachnoid anesthesia; Procedure: PCA (patient controlled analgesia); Drug: Metamizol; Drug: Ketoprofen; Drug: Bupivacaine
QLBExperimentalSubarchnoid anesthesia with bupivacaine QLB (quadratus lumborum block) ultrasound-guided regional block between abdominal wall muscles to treat acute postoperative pain. Stimuplex Ultra 360 needle will be used and 0.375 % ropivacaine administered (0.2 mL/kg) at the and of cesarean section. PCA with morphine in the PACU
Receives: Procedure: QLB (quadratus lumborum block); Device: Stimuplex Ultra 360 needle; Drug: Ropivacaine; Drug: Paracetamol; Procedure: subarachnoid anesthesia; Procedure: PCA (patient controlled analgesia); Drug: Metamizol; Drug: Ketoprofen; Drug: Bupivacaine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Postoperative pain measured with VAS

    Acute pain measured with VAS (visual-analogue scale)

    Measured: up to 24 hours after surgery

Secondary outcomes (2)

  1. Neuropathic pain assessed with NPSI

    Neuropathic pain occurrence with Neuropathic Pain Symptom Inventory (NPSI)

    Measured: 6 months from the surgery

  2. Morphine consumption

    Total morphine consumption

    Measured: up to 24 hours after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Aug 2017
  2. Study start4 Sep 2017
  3. Primary completion29 Oct 2018
  4. Study completion30 Aug 2019

Resources

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
Participants were randomized 1:1:1
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
105 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03244540
Sponsor's protocol ID
KE-0254/127/2017
Status last verified
Feb 2020
First submitted
4 Aug 2017
Last updated
18 Feb 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
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 24249997

  • Kadam 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 25788791

  • Borys M, Zamaro A, Horeczy B, Geszka E, Janiak M, Wegrzyn P, Czuczwar M, Piwowarczyk P. Quadratus Lumborum and Transversus Abdominis Plane Blocks and Their Impact on Acute and Chronic Pain in Patients after Cesarean Section: A Randomized Controlled Study. Int J Environ Res Public Health. 2021 Mar 28;18(7):3500. doi: 10.3390/ijerph18073500.

    PubMed 33800559

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing TAP (transversus abdominis plane block), QLB (quadratus lumborum block) and Stimuplex Ultra 360 needle in people with Cesarean Section and Pain, Postoperative, run by Medical University of Lublin at 2 sites 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 18 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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 NCT03244540, 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 18 Feb 2020.

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Regional Analgesia After Cesarean Section | AzTrials