Comparison of Two Pain-treatment Techniques After Cesarean Section
NCT ID: NCT02804126
Last Updated: 2023-11-28
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
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COMPLETED
PHASE4
232 participants
INTERVENTIONAL
2017-06-01
2018-07-31
Brief Summary
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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
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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TAP (transversus abdominis plane)
Ultrasound-guided transversus abdominis plane block at the end of cesarean section
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).
Bupivacaine
In both groups (TAP\&QL) 0.25% bupivacaine 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
Metamizol
Intravenous metamizol 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)
QL (quadratus lumborum)
Ultrasound-guided quadratus lumborum block at the end of cesarean section
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).
Bupivacaine
In both groups (TAP\&QL) 0.25% bupivacaine 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
Metamizol
Intravenous metamizol 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
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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).
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).
Bupivacaine
In both groups (TAP\&QL) 0.25% bupivacaine 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
Metamizol
Intravenous metamizol 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
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Inclusion Criteria
* singleton pregnancy
* subarachnoid anaesthesia
Exclusion Criteria
* allergy to to local anesthetics
* depression, antidepressant drugs treatment
* epilepsy
* usage of painkiller before surgery
* addiction to alcohol or recreational drugs
18 Years
75 Years
FEMALE
No
Sponsors
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Michał Borys
OTHER
Responsible Party
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Michał Borys
associate professor
Principal Investigators
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Miroslaw Czuczwar, MD, PhD
Role: STUDY_CHAIR
II Department of Anesthesiology and Intensive Care Medial University of Lublin
Locations
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II Department of Anesthesia and Intensive Care
Lublin, , Poland
Countries
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References
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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.
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.
Kanazi 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.
Other Identifiers
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KE-0254/85/2016
Identifier Type: -
Identifier Source: org_study_id