Continuous TQL Block for Elective Cesarean Section
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|ClinicalTrials.gov Identifier: NCT03663478|
Recruitment Status : Recruiting
First Posted : September 10, 2018
Last Update Posted : July 17, 2019
|Condition or disease||Intervention/treatment||Phase|
|Postoperative Pain Anesthesia, Local||Drug: Ropivacaine Drug: Saline||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||24 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
Active Comparator: Intervention
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
2 x 30 mL isotonic saline and an elastomere pump with 200 ml isotonic saline, infusion rate 8 ml/hour
- Time to first opioid [ Time Frame: 24 hours postoperatively ]The time from catheters placement to the administration of opioids
- 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.
- 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).
- 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)).
- Patient satisfaction with application of the catheters. [ Time Frame: 24 hours ]NRS 0-10/10 during placement of catheters
- 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.
- Time from operation to ambulation. [ Time Frame: 24 hours ]Time from operation to ambulation.
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
|Contact: Jens Børglum, MD PhDfirstname.lastname@example.org|
|Contact: Gudny Steingrimsdottir, MDemail@example.com|
|Study Chair:||Jens Børglum, MD PhD||Zealand University Hospital, University of Copenhagen|