Comparison of Two Analgesic Strategies After Scheduled Caesarean

Analgesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04755712
• Other study ID #: 2020-A03334-35
• Status: Completed
• Phase: Phase 4
• Start date: March 22, 2021
• Est. completion date: October 12, 2022

Study information

• Verified date: October 2022
• Source: GCS Ramsay Santé pour l'Enseignement et la Recherche
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: October 12, 2022
• Est. primary completion date: October 12, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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;

Related Conditions & MeSH terms

• Analgesia

Intervention

Drug:
• Rachianesthesia
Administration of different anesthesia drugs in accordance with the courant practice (mixture of bupivacaine and sufentanil)
• Sodium Chloride Injection
Subcutaneous injection of Sodium chloride at the usual quadratum lumburum block 2 (QLB2) injection site under ultrasound ("sham-QLB2").
• Morphine
Morphine via pump (patient controlled analgesia)

Locations

Country	Name	City	State
France	MAUPAIN	Quincy-sous-Sénart

Sponsors (1)

Lead Sponsor	Collaborator
GCS Ramsay Santé pour l'Enseignement et la Recherche

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	2 days
Secondary	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
Secondary	Side effects of the two analgesic strategies	Evaluate the side effects of the two analgesic strategies reported in a case report form	2 days