Comparison of Two Analgesic Strategies After Scheduled Caesarean

Comparison of Two Analgesic Strategies After Scheduled Caesarean : Block of the Lumbar Region With Ropivacaine Versus Intrathecal Morphine

To demonstrate the superiority of square lumbar block to ropivacaine compared to intrathecal morphine in the efficacy of postoperative analgesia following scheduled caesarean.

Study Overview

• Status: Completed
• Conditions: Analgesia
• Intervention / Treatment: Drug: Rachianesthesia; Drug: Morphine; Drug: Sodium Chloride Injection

Detailed Description

Interventional, comparative, randomized, controlled study versus reference therapeutic strategy, in 2 parallel groups, double-blind (patient and evaluator), single-center, aiming to demonstrate the superiority of ropivacaine in square lumbar block versus intrathecal morphine, on the efficacy of post-operative analgesia, following a scheduled caesarean.

• Study Type: Interventional
• Enrollment (Actual): 104
• Phase: Phase 4

Contacts and Locations

Study Locations

• France
  • Quincy-sous-Sénart, France, 91480
    • MAUPAIN

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patient to undergo a scheduled caesarean under spinal anesthesia, for the birth of a term baby with a Pfannenstiel-type incision;
• Patient in good health ;
• Patient able to understand the information related to the study, read the information leaflet and agree to sign the consent form.

Exclusion Criteria:

• Pregnancy less than 37 weeks with amenorrhea;
• Multiple pregnancy;
• Fetal pathology known at the time of inclusion;
• Body mass index> 45 kg / m²;
• History of scoliosis or spine surgery;
• History of chronic pain associated with taking opiates, neuropathic pain, neurological pathology;
• Preoperative anemia (blood hemoglobin <9 g / dL);
• Hypersensitivity to ropivacaine or other local anesthetics with amide bond;
• Hypersensitivity to morphine or opioids;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ropivacaine in quadratum lumburum block 2; Ropivacaine will be administrated in perineural in quadratum lumburum block 2 after the caesarian.	Drug: Rachianesthesia; Administration of different anesthesia drugs in accordance with the courant practice (mixture of bupivacaine and sufentanil); Other Names: Bupivacaine and sufentanil; Drug: Morphine; Morphine via pump (patient controlled analgesia); Other Names: injection of morphine
Active Comparator: Intrathecal morphine; Morphine will be administrated in intrathecal	Drug: Rachianesthesia; Administration of different anesthesia drugs in accordance with the courant practice (mixture of bupivacaine and sufentanil); Other Names: Bupivacaine and sufentanil; Drug: Morphine; Morphine via pump (patient controlled analgesia); Other Names: injection of morphine; Drug: Sodium Chloride Injection; Subcutaneous injection of Sodium chloride at the usual quadratum lumburum block 2 (QLB2) injection site under ultrasound ("sham-QLB2").; Other Names: sham-QLB2

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cumulative quantity of morphine received postoperatively via pump	The main objective of the study is to demonstrate the superiority of square lumbar block to ropivacaine (quadratum lumburum block 2 - QLB2) in comparison to intrathecal morphine in the efficacy of postoperative analgesia following a scheduled Caesarean.	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Characteristics of postoperative pain using a visual analogic scale	Evaluate the characteristics of postoperative pain in both groups with the use of a visual analog scale	2 days
Side effects of the two analgesic strategies	Evaluate the side effects of the two analgesic strategies reported in a case report form	2 days
Cumulative quantity of morphine received postoperatively via pump	Demonstrate the superiority of square lumbar block to ropivacaine (quadratum lumburum block 2 - QLB2) in comparison to intrathecal morphine in the efficacy of postoperative analgesia following a scheduled Caesarean.	2 days

Collaborators and Investigators

• Sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche

Study record dates

Study Major Dates

• Study Start (Actual): March 22, 2021
• Primary Completion (Actual): October 12, 2022
• Study Completion (Actual): October 12, 2022

Study Registration Dates

• First Submitted: February 8, 2021
• First Submitted That Met QC Criteria: February 12, 2021
• First Posted (Actual): February 16, 2021

Study Record Updates

• Last Update Posted (Actual): August 5, 2024
• Last Update Submitted That Met QC Criteria: August 1, 2024
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Opioid; Narcotics; Adjuvants, Anesthesia; Anesthetics, Local; Bupivacaine; Morphine; Sufentanil
• Other Study ID Numbers: 2020-A03334-35

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No