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Continuous TQL Block for Elective Cesarean Section

Primary Purpose

Postoperative Pain, Anesthesia, Local

Status
Completed
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
Ropivacaine
Saline
Sponsored by
Zealand University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Department of anaesthesiology

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Intervention

Control

Arm Description

Ropivacaine

Isotonic saline

Outcomes

Primary Outcome Measures

Time to first opioid
The time from catheters placement to the administration of opioids

Secondary Outcome Measures

Pain intensity (NRS 0-10/10)
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.
Total morphine consumption.
Morphine consumption at 3, 6, 9, 12 and 24 postoperative hours (data from PCA pump and patient medical record).
Catheter displacement.
Frequency of displacement of catheters (early displacement evaluated after 2 hours (T2), late displacement evaluated after 24 hours (T24)).
Patient satisfaction with application of the catheters.
NRS 0-10/10 during placement of catheters
The degree of morphine-related side effects (PONV, itching, fatigue, etc.).
On a scale from 0-3, where 0 is none, 1 is mild, 2 is moderate and 3 is severe.
Time from operation to ambulation.
Time from operation to ambulation.

Full Information

First Posted
September 4, 2018
Last Updated
March 2, 2021
Sponsor
Zealand University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03663478
Brief Title
Continuous TQL Block for Elective Cesarean Section
Official Title
Ultrasound-guided Transmuscular Quadratus Lumborum Catheters for Elective Caesarean Section. A Double Blind, Randomise, Placebo Controlled Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
September 4, 2018 (Actual)
Primary Completion Date
April 8, 2020 (Actual)
Study Completion Date
April 8, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zealand University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain, Anesthesia, Local

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Active Comparator
Arm Description
Ropivacaine
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Isotonic saline
Intervention Type
Drug
Intervention Name(s)
Ropivacaine
Intervention Description
2 x 30 ml ropivacaine 0,2% and an elastomere pump with 200 ml ropivacaine 0,2%, infusion rate 8 ml/hour
Intervention Type
Drug
Intervention Name(s)
Saline
Intervention Description
2 x 30 mL isotonic saline and an elastomere pump with 200 ml isotonic saline, infusion rate 8 ml/hour
Primary Outcome Measure Information:
Title
Time to first opioid
Description
The time from catheters placement to the administration of opioids
Time Frame
24 hours postoperatively
Secondary Outcome Measure Information:
Title
Pain intensity (NRS 0-10/10)
Description
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.
Time Frame
24 hours postoperatively
Title
Total morphine consumption.
Description
Morphine consumption at 3, 6, 9, 12 and 24 postoperative hours (data from PCA pump and patient medical record).
Time Frame
24 hours
Title
Catheter displacement.
Description
Frequency of displacement of catheters (early displacement evaluated after 2 hours (T2), late displacement evaluated after 24 hours (T24)).
Time Frame
24 hours
Title
Patient satisfaction with application of the catheters.
Description
NRS 0-10/10 during placement of catheters
Time Frame
24 hours
Title
The degree of morphine-related side effects (PONV, itching, fatigue, etc.).
Description
On a scale from 0-3, where 0 is none, 1 is mild, 2 is moderate and 3 is severe.
Time Frame
24 hours
Title
Time from operation to ambulation.
Description
Time from operation to ambulation.
Time Frame
24 hours

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jens Børglum, MD PhD
Organizational Affiliation
Zealand University Hospital, University of Copenhagen
Official's Role
Study Chair
Facility Information:
Facility Name
Department of anaesthesiology
City
Roskilde
ZIP/Postal Code
4000
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32270474
Citation
Steingrimsdottir GE, Hansen CK, Borglum J. Ultrasound-guided transmuscular quadratus lumborum catheters for elective caesarean section: A protocol for a single-centre, double-blind randomised trial. Acta Anaesthesiol Scand. 2020 Sep;64(8):1218-1223. doi: 10.1111/aas.13601. Epub 2020 Apr 22.
Results Reference
derived

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Continuous TQL Block for Elective Cesarean Section

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