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Continuous TQL Block for Elective 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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03663478
Recruitment Status : Recruiting
First Posted : September 10, 2018
Last Update Posted : July 17, 2019
Sponsor:
Information provided by (Responsible Party):
Zealand University Hospital

Brief Summary:
The aim of this study is to investigate whether it is possible to prolong time to first opioid with the TQL block by inserting catheters bilaterally, providing continuous analgesia, in patients undergoing elective CS. Our hypothesis is that it will be possible to significantly extend time to first opioid with the blockade by 66.6%, increasing it from a mean of 5.6 hours to a mean of 10 hours.

Condition or disease Intervention/treatment Phase
Postoperative Pain Anesthesia, Local Drug: Ropivacaine Drug: Saline Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Ultrasound-guided Transmuscular Quadratus Lumborum Catheters for Elective Caesarean Section. A Double Blind, Randomise, Placebo Controlled Trial.
Actual Study Start Date : September 4, 2018
Estimated Primary Completion Date : June 1, 2020
Estimated Study Completion Date : December 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cesarean Section

Arm Intervention/treatment
Active Comparator: Intervention
Ropivacaine
Drug: Ropivacaine
2 x 30 ml ropivacaine 0,2% and an elastomere pump with 200 ml ropivacaine 0,2%, infusion rate 8 ml/hour

Placebo Comparator: Control
Isotonic saline
Drug: Saline
2 x 30 mL isotonic saline and an elastomere pump with 200 ml isotonic saline, infusion rate 8 ml/hour




Primary Outcome Measures :
  1. Time to first opioid [ Time Frame: 24 hours postoperatively ]
    The time from catheters placement to the administration of opioids


Secondary Outcome Measures :
  1. Pain intensity (NRS 0-10/10) [ Time Frame: 24 hours postoperatively ]
    NRS (numeric rating scale) score in the study period at 3, 6, 9, 12 and 24 hours postoperatively. In addition, NRS score will be recorded electronically on all morphine administrations, since all patients must enter their NRS score on the Patient-Controlled Analgesia (PCA) pump display prior to administration of the PCA boluses. NRS is a pain scale where the patient gives her pain a number from 0-10, where 0 is no pain and 10 is the worst pain imaginable.

  2. Total morphine consumption. [ Time Frame: 24 hours ]
    Morphine consumption at 3, 6, 9, 12 and 24 postoperative hours (data from PCA pump and patient medical record).

  3. Catheter displacement. [ Time Frame: 24 hours ]
    Frequency of displacement of catheters (early displacement evaluated after 2 hours (T2), late displacement evaluated after 24 hours (T24)).

  4. Patient satisfaction with application of the catheters. [ Time Frame: 24 hours ]
    NRS 0-10/10 during placement of catheters

  5. The degree of morphine-related side effects (PONV, itching, fatigue, etc.). [ Time Frame: 24 hours ]
    On a scale from 0-3, where 0 is none, 1 is mild, 2 is moderate and 3 is severe.

  6. Time from operation to ambulation. [ Time Frame: 24 hours ]
    Time from operation to ambulation.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18+ years of age.
  • Scheduled for elective Caesarean Section in spinal anaesthesia.
  • Have received thorough information, verbally and in written, and signed the "Informed Consent" form on participation in the trial.

Exclusion Criteria:

  • Inability to cooperate
  • Inability to understand Danish
  • Allergy to local anaesthetics or opioids
  • Excessive daily intake of opioids, according to the discretion of the investigator
  • Local infection at the site of injection or systemic infection
  • Difficult visualisation of muscular and fascial structures on ultrasound, necessary to correct blockade and catheter placement.

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): NCT03663478


Contacts
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Contact: Jens Børglum, MD PhD +4530700120 jens.borglum@gmail.com
Contact: Gudny Steingrimsdottir, MD +4561714389 dr.gudny@gmail.com

Locations
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Denmark
Department of anaesthesiology Recruiting
Roskilde, Denmark, 4000
Contact: Jens Børglum, MD PhD    30700120    jens.borglum@gmail.com   
Contact: Gudny Steingrimsdottir, MD    +4561714389    dr.gudny@gmail.com   
Sponsors and Collaborators
Zealand University Hospital
Investigators
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Study Chair: Jens Børglum, MD PhD Zealand University Hospital, University of Copenhagen
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Zealand University Hospital
ClinicalTrials.gov Identifier: NCT03663478    
Other Study ID Numbers: TQL Catheters
First Posted: September 10, 2018    Key Record Dates
Last Update Posted: July 17, 2019
Last Verified: July 2019
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
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Ropivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents