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Regional Analgesia After Cesarean Section

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03244540
Recruitment Status : Completed
First Posted : August 9, 2017
Last Update Posted : February 18, 2020
Sponsor:
Information provided by (Responsible Party):
Michał Borys, Medical University of Lublin

Brief 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. 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).

Condition or disease Intervention/treatment Phase
Cesarean Section Pain, Postoperative Pain, Neuropathic Procedure: TAP (transversus abdominis plane block) 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 Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 105 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants were randomized 1:1:1
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Masking Description: Participants, care providers, and assessors were not aware of type of the block
Primary Purpose: Treatment
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
Actual Study Start Date : September 4, 2017
Actual Primary Completion Date : October 29, 2018
Actual Study Completion Date : August 30, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: PCA
Subarchnoid anesthesia with bupivacaine PCA with morphine in the PACU
Drug: Paracetamol
Intravenous paracetamol will be used (1.0 gram), up to 4 grams per day

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

Procedure: 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)

Drug: Metamizol
Intravenous metamizol will be used (1.0 gram), up to 4 grams per day

Drug: Ketoprofen
Intravenous ketoprofen will be used (0.1 gram), up to 200 milligrams per day

Drug: Bupivacaine
Subarachnoid anesthesia with spinal bupivacaine (MARCAINE SPINAL 0.5% HEAVY)
Other Name: Marcaine

Experimental: 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

Procedure: TAP (transversus abdominis plane block)
ultrasound-guided regional block between abdominal wall muscles to treat acute postoperative pain

Device: Stimuplex Ultra 360 needle
ultrasound-guided needle will be used for QLB and TAP and regional blocks

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

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

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

Procedure: 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)

Drug: Metamizol
Intravenous metamizol will be used (1.0 gram), up to 4 grams per day

Drug: Ketoprofen
Intravenous ketoprofen will be used (0.1 gram), up to 200 milligrams per day

Drug: Bupivacaine
Subarachnoid anesthesia with spinal bupivacaine (MARCAINE SPINAL 0.5% HEAVY)
Other Name: Marcaine

Experimental: 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

Procedure: QLB (quadratus lumborum block)
ultrasound-guided regional block between abdominal wall muscles to treat acute postoperative pain

Device: Stimuplex Ultra 360 needle
ultrasound-guided needle will be used for QLB and TAP and regional blocks

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

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

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

Procedure: 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)

Drug: Metamizol
Intravenous metamizol will be used (1.0 gram), up to 4 grams per day

Drug: Ketoprofen
Intravenous ketoprofen will be used (0.1 gram), up to 200 milligrams per day

Drug: Bupivacaine
Subarachnoid anesthesia with spinal bupivacaine (MARCAINE SPINAL 0.5% HEAVY)
Other Name: Marcaine




Primary Outcome Measures :
  1. Postoperative pain measured with VAS [ Time Frame: up to 24 hours after surgery ]
    Acute pain measured with VAS (visual-analogue scale)


Secondary Outcome Measures :
  1. Neuropathic pain assessed with NPSI [ Time Frame: 6 months from the surgery ]
    Neuropathic pain occurrence with Neuropathic Pain Symptom Inventory (NPSI)

  2. Morphine consumption [ Time Frame: up to 24 hours after surgery ]
    Total morphine consumption



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • obtained consent
  • singleton pregnancy
  • subarachnoid anaesthesia

Exclusion Criteria:

  • coagulopathy
  • allergy to morphine and local anesthetics
  • depression, antidepressant drugs treatment
  • epilepsy
  • usage of painkiller before surgery
  • addiction to alcohol or recreational drugs

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03244540


Locations
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Poland
Szpital Specjalistyczny PRO-FAMILIA w Rzeszowie
Rzeszów, Poland, 35-001
Szpital Kliniczny Dzieciątka Jezus
Warszawa, Poland, 02-005
Sponsors and Collaborators
Medical University of Lublin
Publications:
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Responsible Party: Michał Borys, associate professor, Medical University of Lublin
ClinicalTrials.gov Identifier: NCT03244540    
Other Study ID Numbers: KE-0254/127/2017
First Posted: August 9, 2017    Key Record Dates
Last Update Posted: February 18, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Michał Borys, Medical University of Lublin:
postoperative pain
transversus abdominis plane block
quadratus lumborum block
neuropathic pain
Additional relevant MeSH terms:
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Neuralgia
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Acetaminophen
Dipyrone
Ketoprofen
Bupivacaine
Ropivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Analgesics, Non-Narcotic
Analgesics
Antipyretics
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action