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Ultrasound-guided Transmuscular Quadratus Lumborum Block for Elective Caesarean Section.

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ClinicalTrials.gov Identifier: NCT03068260
Recruitment Status : Completed
First Posted : March 1, 2017
Last Update Posted : March 23, 2018
Sponsor:
Information provided by (Responsible Party):
Zealand University Hospital

Brief Summary:
ECS is a very common procedure. A 1-year retrospective survey revealed a vast opioid consumption among the new mothers of approximately (mean±SD) 35±25 mg of oral morphine in the first 24 postoperative hours despite a multimodal analgesic regimen. The adverse effects of morphine are well known and include postoperative nausea and vomiting (PONV), itching, fatigue, constipation, confusion, respiratory depression and delayed mobilization. These adverse effects are unsound for the new mothers as well as the breast-fed, newborn children. This study aims to evaluate the efficacy of bilateral Transmuscular Quadratus Lumborum (TQL) block in reducing postoperative morphine consumption and pain.

Condition or disease Intervention/treatment Phase
Postoperative Pain Drug: Ropivacaine Drug: Saline Drug: Acetaminophen Drug: Ibuprofen 400Mg Tablet / Celebra 100 Mg tablet Device: ultrasound-guided nerve block Drug: Morphine Device: Patient-controlled analgesia Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 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 Block for Elective Caesarean Section. A Double Blind, Randomized, Placebo Controlled Trial.
Actual Study Start Date : March 15, 2017
Actual Primary Completion Date : December 1, 2017
Actual Study Completion Date : December 1, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cesarean Section

Arm Intervention/treatment
Active Comparator: Active

Active bilateral ultrasound-guided transmuscular quadratus lumborum (TQL) block. 60 ml ropivacaine 0,375% single shot.

In both arms, the participants receive 1g Acetaminophen and 400 mg Ibuprofen / 100 mg Celebra. Morphine will be administered IV as part of a PCA-pump regimen or additionally after contact with the nursing staff as it is the standard treatment.

Drug: Ropivacaine
30 ml ropivacaine 0,375% administered on each side as bilateral TQL blocks

Drug: Acetaminophen
1 g orally administered postoperatively

Drug: Ibuprofen 400Mg Tablet / Celebra 100 Mg tablet
orally administered postoperatively

Device: ultrasound-guided nerve block
Transmuscular quadratus lumborum block, ultrasound-guided

Drug: Morphine
intravenously administered morphine via PCA-pump

Device: Patient-controlled analgesia
PCA-pump with IV-Morphine. 5 mg administered per bolus. Lock-out time and max. dosage standardized.

Placebo Comparator: Placebo

Placebo bilateral ultrasound-guided transmuscular quadratus lumborum (TQL) block. 60 ml saline single shot.

In both arms, the participants receive 1g Acetaminophen and 400 mg Ibuprofen / 100 mg Celebra. Morphine will be administered IV as part of a PCA-pump regimen or additionally after contact with the nursing staff as it is the standard treatment.

Drug: Saline
30 ml saline 0,375% administered on each side as bilateral TQL blocks

Drug: Acetaminophen
1 g orally administered postoperatively

Drug: Ibuprofen 400Mg Tablet / Celebra 100 Mg tablet
orally administered postoperatively

Device: ultrasound-guided nerve block
Transmuscular quadratus lumborum block, ultrasound-guided

Drug: Morphine
intravenously administered morphine via PCA-pump

Device: Patient-controlled analgesia
PCA-pump with IV-Morphine. 5 mg administered per bolus. Lock-out time and max. dosage standardized.




Primary Outcome Measures :
  1. Morphine consumption [ Time Frame: Twenty-four hours postoperatively ]
    Data from PCA pump and patient medical record


Secondary Outcome Measures :
  1. Pain intensity (NRS 0-10/10) [ Time Frame: At 6, 12, 24, 36, 48 hours postoperatively. ]
    NRS score will be recorded electronically on all morphine administrations, since all patients must enter their NRS score on the PCA pump display prior to administration of the PCA boluses.

  2. Total morphine consumption. [ Time Frame: At 6, 12, 36 and 48 postoperative hours. ]
    Data from PCA pump and patient medical record

  3. Duration of block [ Time Frame: Time to first opioid within the first 24 postoperative hours. ]
    How long time does the TQL block work

  4. Patient satisfaction with application of the block. Satisfaction measured on NRS. [ Time Frame: Immediately after application ]
    0=Complete satisfaction 10=Unmanageable dissatisfaction

  5. The degree of morphine-related side effects. Nausea or PONV registered on CRF if any. [ Time Frame: 48 hours ]
    PONV. 0-3; 0=No nausea. 3=Unmanageable nausea

  6. Time from operation to ambulation [ Time Frame: Within the first 24 postoperative hours ]
    When does the new mother ambulate. I.e. Unassisted visit at the bathroom.



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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Only women scheduled for elective caesarean section are eligible.
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Pregnant women scheduled for elective Caesarean Section in spinal anaesthesia.
  • Have received thorough information, orally and in written, and signed the "Informed Consent" form on participation in the trial

Exclusion Criteria:

  • Inability to cooperate
  • Inability to speak and understand Danish
  • Allergy to local anaesthetics or opioids
  • Daily intake of opioids
  • Local infection at the site of injection or systemic infection
  • Difficulty visualisation of muscular and fascial structures in ultrasound visualisation necessary to the block administration

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): NCT03068260


Locations
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Denmark
ZUH
Roskilde, Danmark, Denmark, 4000
Sponsors and Collaborators
Zealand University Hospital

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Responsible Party: Zealand University Hospital
ClinicalTrials.gov Identifier: NCT03068260     History of Changes
Other Study ID Numbers: ZUH-TQL-ECS
First Posted: March 1, 2017    Key Record Dates
Last Update Posted: March 23, 2018
Last Verified: March 2018
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
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Zealand University Hospital:
caesarean section
postoperative pain
transmuscular quadratus lumborum block
reduction of opioid consumption
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Acetaminophen
Ibuprofen
Morphine
Ropivacaine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anesthetics, Local
Anesthetics
Analgesics, Non-Narcotic
Antipyretics
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action