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

NCT04562103 | Completed

• 1 other identifier: ID 2979
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Quadratus lomborum block; Ropivacaine; Epinephrine

Outcome Measures

Primary Outcomes (2)

• Postoperative pain

  To evaluate if the adjunct of epinephrine to local anesthetic would results in a reduction in postoperative pain compared to the block performed with ropivacaine alone. Pain at rest and with movement recorded with a visual analogue scale (from 0 to 10).

  at 6, 12 and 24 hours after the end of surgery

• Postoperative analgesic requirement

  To evaluate if the adjunct of epinephrine to local anesthetic would results in a longer sensory block duration compared to the block performed with ropivacaine alone. Time between the block and first opioid analgesic requirement (minutes).

  First 24 hours after the end of surgery

Secondary Outcomes (1)

• Plasmatic concentration of Ropivacaine

  At 10, 30, 45, 60, 120 minutes after the block

Study Arms (2)

Epinephrine QLB

EXPERIMENTAL

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

Drug: Epinephrine / Ropivacaine

Plane QLB

ACTIVE COMPARATOR

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

Drug: Ropivacaine

Interventions

Epinephrine / Ropivacaine DRUG

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

Epinephrine QLB

Ropivacaine DRUG

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

Plane QLB

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Caesarean Section
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• first singleton pregnancy at term
• American Society of Anesthesiologists (ASA) physical status II;
• caesarean section under Spinal Anesthesia

You may not qualify if:

• patients enable to comprehend or use the verbal rating pain scoring system or patient controlled analgesia (PCA) pump;
• congenital coagulopathy;
• anatomical abnormalities;
• localized infections;
• use of drugs interfering with ropivacaine metabolism.

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

IRCCS Policlinico Agostino Gemelli

Rome, 00168, Italy

Location

MeSH Terms

Interventions

Epinephrine; Ropivacaine

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Anilides; Amides; Aniline Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2020
• First Posted: September 24, 2020
• Study Start: July 3, 2020
• Primary Completion: August 3, 2020
• Study Completion: September 3, 2020
• Last Updated: October 8, 2020

Record last verified: 2020-07

Locations

IT (1)