Comparison of Two Analgesic Strategies After Scheduled Caesarean

Phase 4

Completed

• Conditions: Analgesia
• Interventions: Drug: Rachianesthesia; Drug: Sodium Chloride Injection; Drug: Morphine

• Registration Number: NCT04755712
• Lead Sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche

Brief Summary

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

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 Timeline

• Study First Submitted: 2021-02-08
• Study First Submitted QC: 2021-02-12
• Study First Posted: 2021-02-16
• Study Start: 2021-03-22
• Status Verified: 2022-10
• Primary Completion: 2022-10-12
• Study Completion: 2022-10-12
• Last Update Submitted: 2024-08-01
• Last Update Posted: 2024-08-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 104

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intrathecal morphine	Rachianesthesia	Morphine will be administrated in intrathecal
ropivacaine in quadratum lumburum block 2	Rachianesthesia	Ropivacaine will be administrated in perineural in quadratum lumburum block 2 after the caesarian.
Intrathecal morphine	Sodium Chloride Injection	Morphine will be administrated in intrathecal
ropivacaine in quadratum lumburum block 2	Morphine	Ropivacaine will be administrated in perineural in quadratum lumburum block 2 after the caesarian.
Intrathecal morphine	Morphine	Morphine will be administrated in intrathecal

Primary Outcome Measures

Name	Time	Method
Cumulative quantity of morphine received postoperatively via pump	1 day	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.

Secondary Outcome Measures

Name	Time	Method
Cumulative quantity of morphine received postoperatively via pump	2 days	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.
Characteristics of postoperative pain using a visual analogic scale	2 days	Evaluate the characteristics of postoperative pain in both groups with the use of a visual analog scale
Side effects of the two analgesic strategies	2 days	Evaluate the side effects of the two analgesic strategies reported in a case report form

Trial Locations

Locations (1)

MAUPAIN; 🇫🇷 Quincy-sous-Sénart, France