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
105 participants
INTERVENTIONAL
2017-09-04
2019-08-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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PCA
Subarchnoid anesthesia with bupivacaine PCA with morphine in the PACU
Paracetamol
Intravenous paracetamol will be used (1.0 gram), up to 4 grams per day
subarachnoid anesthesia
subarachnoid anesthesia for each patients participating in the study with pencil point needle
PCA (patient controlled analgesia)
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)
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
Bupivacaine
Subarachnoid anesthesia with spinal bupivacaine (MARCAINE SPINAL 0.5% HEAVY)
TAP
Subarchnoid 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
TAP (transversus abdominis plane block)
ultrasound-guided regional block between abdominal wall muscles to treat acute postoperative pain
Stimuplex Ultra 360 needle
ultrasound-guided needle will be used for QLB and TAP and regional blocks
Ropivacaine
0.375 % ropivacaine will be administered for both QLB and TAP (0.2 mL per kg on both sides)
Paracetamol
Intravenous paracetamol will be used (1.0 gram), up to 4 grams per day
subarachnoid anesthesia
subarachnoid anesthesia for each patients participating in the study with pencil point needle
PCA (patient controlled analgesia)
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)
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
Bupivacaine
Subarachnoid anesthesia with spinal bupivacaine (MARCAINE SPINAL 0.5% HEAVY)
QLB
Subarchnoid 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
QLB (quadratus lumborum block)
ultrasound-guided regional block between abdominal wall muscles to treat acute postoperative pain
Stimuplex Ultra 360 needle
ultrasound-guided needle will be used for QLB and TAP and regional blocks
Ropivacaine
0.375 % ropivacaine will be administered for both QLB and TAP (0.2 mL per kg on both sides)
Paracetamol
Intravenous paracetamol will be used (1.0 gram), up to 4 grams per day
subarachnoid anesthesia
subarachnoid anesthesia for each patients participating in the study with pencil point needle
PCA (patient controlled analgesia)
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)
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
Bupivacaine
Subarachnoid anesthesia with spinal bupivacaine (MARCAINE SPINAL 0.5% HEAVY)
Interventions
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TAP (transversus abdominis plane block)
ultrasound-guided regional block between abdominal wall muscles to treat acute postoperative pain
QLB (quadratus lumborum block)
ultrasound-guided regional block between abdominal wall muscles to treat acute postoperative pain
Stimuplex Ultra 360 needle
ultrasound-guided needle will be used for QLB and TAP and regional blocks
Ropivacaine
0.375 % ropivacaine will be administered for both QLB and TAP (0.2 mL per kg on both sides)
Paracetamol
Intravenous paracetamol will be used (1.0 gram), up to 4 grams per day
subarachnoid anesthesia
subarachnoid anesthesia for each patients participating in the study with pencil point needle
PCA (patient controlled analgesia)
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)
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
Bupivacaine
Subarachnoid anesthesia with spinal bupivacaine (MARCAINE SPINAL 0.5% HEAVY)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* singleton pregnancy
* subarachnoid anaesthesia
Exclusion Criteria
* allergy to morphine and 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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Medical University of Lublin
OTHER
Responsible Party
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Michał Borys
associate professor
Locations
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Szpital Specjalistyczny PRO-FAMILIA w Rzeszowie
Rzeszów, , Poland
Szpital Kliniczny Dzieciątka Jezus
Warsaw, , 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.
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.
Other Identifiers
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KE-0254/127/2017
Identifier Type: -
Identifier Source: org_study_id
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