Continuous TQL Block for Elective Cesarean Section

Postoperative Pain Clinical Trial

Official title:

Ultrasound-guided Transmuscular Quadratus Lumborum Catheters for Elective Caesarean Section. A Double Blind, Randomise, Placebo Controlled Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03663478
• Other study ID #: TQL Catheters
• Status: Completed
• Phase: Phase 4
• Start date: September 4, 2018
• Est. completion date: April 8, 2020

Study information

• Verified date: March 2021
• Source: Zealand University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: April 8, 2020
• Est. primary completion date: April 8, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anesthesia, Local
• Pain, Postoperative
• Postoperative Pain

Intervention

Drug:
• Ropivacaine
2 x 30 ml ropivacaine 0,2% and an elastomere pump with 200 ml ropivacaine 0,2%, infusion rate 8 ml/hour
• Saline
2 x 30 mL isotonic saline and an elastomere pump with 200 ml isotonic saline, infusion rate 8 ml/hour

Locations

Country	Name	City	State
Denmark	Department of anaesthesiology	Roskilde

Sponsors (1)

Lead Sponsor	Collaborator
Zealand University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to first opioid	The time from catheters placement to the administration of opioids	24 hours postoperatively
Secondary	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.	24 hours postoperatively
Secondary	Total morphine consumption.	Morphine consumption at 3, 6, 9, 12 and 24 postoperative hours (data from PCA pump and patient medical record).	24 hours
Secondary	Catheter displacement.	Frequency of displacement of catheters (early displacement evaluated after 2 hours (T2), late displacement evaluated after 24 hours (T24)).	24 hours
Secondary	Patient satisfaction with application of the catheters.	NRS 0-10/10 during placement of catheters	24 hours
Secondary	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.	24 hours
Secondary	Time from operation to ambulation.	Time from operation to ambulation.	24 hours