Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Comparison of Two Pain-treatment Techniques 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: NCT02804126
Recruitment Status : Unknown
Verified May 2017 by Michał Borys, Medical University of Lublin.
Recruitment status was:  Recruiting
First Posted : June 17, 2016
Last Update Posted : May 2, 2017
Sponsor:
Information provided by (Responsible Party):
Michał Borys, Medical University of Lublin

Brief Summary:

Comparison of two types of analgesia after cesarean section.

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).


Condition or disease Intervention/treatment Phase
Cesarean Section Pain Management Neuropathic Pain Procedure: TAP (transversus abdominis plane block) Procedure: QL (quadratus lumborum block) Drug: Bupivacaine Device: Needle Drug: Paracetamol Drug: Metamizol Drug: Ketoprofen Drug: Morphine 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.

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Effectiveness of Transversus Abdominis Plane Block Versus Quadratus Lumborum Technique in Patients After Cesarean Section
Study Start Date : June 2016
Estimated Primary Completion Date : August 2017
Estimated Study Completion Date : November 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cesarean Section

Arm Intervention/treatment
Experimental: TAP (transversus abdominis plane)
Ultrasound-guided transversus abdominis plane block at the end of cesarean section
Procedure: 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).

Drug: Bupivacaine
In both groups (TAP&QL) 0.25% bupivacaine will be given (0.2 mL/kg)

Device: Needle
Ultrasound-guided, Stimuplex ultra 360 needle will be used in the study

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

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: Morphine
Intravenous morphine (5 mg) will be given when pain exceeds 40 mm in VAS (maximum 2 doses per day)

Experimental: QL (quadratus lumborum)
Ultrasound-guided quadratus lumborum block at the end of cesarean section
Procedure: 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).

Drug: Bupivacaine
In both groups (TAP&QL) 0.25% bupivacaine will be given (0.2 mL/kg)

Device: Needle
Ultrasound-guided, Stimuplex ultra 360 needle will be used in the study

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

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: Morphine
Intravenous morphine (5 mg) will be given when pain exceeds 40 mm in VAS (maximum 2 doses per day)




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)



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.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • obtained consent
  • singleton pregnancy
  • subarachnoid anaesthesia

Exclusion Criteria:

  • coagulopathy
  • allergy to to 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): NCT02804126


Contacts
Layout table for location contacts
Contact: Michal Borys, MD, PhD +48 81532 2713 michalborys@umlub.pl

Locations
Layout table for location information
Poland
II Department of Anesthesia and Intensive Care Recruiting
Lublin, Poland, 20-081
Contact: Michał Borys, M.D. Ph.D    506350569    michalborys1@gmail.com   
Sponsors and Collaborators
Michał Borys
Investigators
Layout table for investigator information
Study Chair: Miroslaw Czuczwar, MD, PhD II Department of Anesthesiology and Intensive Care Medial University of Lublin
Publications:
Layout table for additonal information
Responsible Party: Michał Borys, associate professor, Medical University of Lublin
ClinicalTrials.gov Identifier: NCT02804126    
Other Study ID Numbers: KE-0254/85/2016
First Posted: June 17, 2016    Key Record Dates
Last Update Posted: May 2, 2017
Last Verified: May 2017
Keywords provided by Michał Borys, Medical University of Lublin:
acute pain
transversus abdominis plane block
quadratus lumborum block
neuropathic pain
Additional relevant MeSH terms:
Layout table for MeSH terms
Neuralgia
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Acetaminophen
Dipyrone
Ketoprofen
Morphine
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Analgesics, Opioid
Narcotics
Analgesics
Analgesics, Non-Narcotic
Antipyretics
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action