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Ropivacaine Plasma Concentration With or Without Epinephrine for Posterior Quadratus Lumborum Block

NCT04562103 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2020-10-08

No results posted yet for this study

Summary

Introduction The posterior Quadratus Lumborum Block (pQLB) has been used in postoperative pain management after Cesarean Section (CS). However, there are no data about pQLB safety in pregnants, at increased risk of local anesthetic systemic toxicity (LAST). The purpose of the present study was to explore the efficacy and the safety of adding epinephrine to ropivacaine for bilateral pQLB vs. bilateral pQLB performed with ropivacaine alone in CS.

Methods Fifty-two pregnants were consecutively allocated to one of 2 groups \[e-pQLB (0.375% ropivacaine+100 mcg epinephrine) or pQLB (0.375% ropivacaine)\] and the investigators evaluated if the adjunct of epinephrine to ropivacaine increases of efficacy (measured as opioid consumption during the first 24 postoperative hours, time for first request of opioid and pain values reported by patients) and the safety (measured as peak and plasmatic concentration of ropivacaine) of pQLB.

Conditions

  • Local Anesthetic Systemic Toxicity
  • Anesthesia, Local

Interventions

DRUG

Epinephrine / Ropivacaine

In this group quadratus lomborum block was performed with 0.375% ropivacaine+100 mcg epinephrine.

DRUG

Ropivacaine

In this group quadratus lomborum block was performed with plane 0.375% ropivacaine.

Sponsors & Collaborators

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-03
Primary Completion
2020-08-03
Completion
2020-09-03

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04562103 on ClinicalTrials.gov