Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE4
105 participants
INTERVENTIONAL
2018-02-07
2019-04-17
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
TAP
Ultrasound-guided transversus abdominis plane block at the end of cesarean section
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).
Ropivacaine
In both groups (TAP\&QLB) 0.375% ropivacaine will be given (0.2 mL/kg)
Needle
Ultrasound-guided, Stimuplex ultra 360 needle will be used in the study
paracetamol
Intravenous paracetamol will be used (1.0 gram), up to 4 grams per day
metamizole
Intravenous metamizole will be used (1.0 gram), up to 4 grams per day
Ketoprofen
Intravenous ketoprofen will be used (0.1 gram), up to 200 milligrams per day
Morphine
Intravenous morphine (5 mg) will be given when pain exceeds 40 mm in VAS (maximum 2 doses per day)
QLB
Ultrasound-guided quadratus lumborum block at the end of cesarean section
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).
Ropivacaine
In both groups (TAP\&QLB) 0.375% ropivacaine will be given (0.2 mL/kg)
Needle
Ultrasound-guided, Stimuplex ultra 360 needle will be used in the study
paracetamol
Intravenous paracetamol will be used (1.0 gram), up to 4 grams per day
metamizole
Intravenous metamizole will be used (1.0 gram), up to 4 grams per day
Ketoprofen
Intravenous ketoprofen will be used (0.1 gram), up to 200 milligrams per day
Morphine
Intravenous morphine (5 mg) will be given when pain exceeds 40 mm in VAS (maximum 2 doses per day)
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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).
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).
Ropivacaine
In both groups (TAP\&QLB) 0.375% ropivacaine will be given (0.2 mL/kg)
Needle
Ultrasound-guided, Stimuplex ultra 360 needle will be used in the study
paracetamol
Intravenous paracetamol will be used (1.0 gram), up to 4 grams per day
metamizole
Intravenous metamizole will be used (1.0 gram), up to 4 grams per day
Ketoprofen
Intravenous ketoprofen will be used (0.1 gram), up to 200 milligrams per day
Morphine
Intravenous morphine (5 mg) will be given when pain exceeds 40 mm in VAS (maximum 2 doses per day)
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* singleton pregnancy
* subarachnoid anesthesia
Exclusion Criteria
* allergy to local anesthetics
* depression, antidepressant drugs treatment
* epilepsy
* usage of painkiller before surgery
* addiction to alcohol or recreational drugs
18 Years
70 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Medical University of Lublin
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Michał Borys
associate professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Mirosław Czuczwar, M.D., PhD
Role: STUDY_CHAIR
Medical University of Lublin
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
II Department of Anesthesia and Intensive Care, Medical University of Lublin
Lublin, , Poland
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
KE-0254/238/2017
Identifier Type: -
Identifier Source: org_study_id