Ultrasound Guided QLB III Versus Intrathecal Morphine for Analgesia After Cesarean Section

NCT03428880 | Completed Phase 4

• 1 other identifier: fel-bich
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 2

Brief Summary

Subarachnoid morphine (SAM) is the gold standard for treating postoperative pain after cesarean delivery (CD) but it has undesirable side effects, that's why the aim of our study is to identify whether ultrasound-guided Quadratus lumborum block type 3, a new regional anesthetic technique that blocks the abdominal wall neural afferents, can provide at the same time better postoperative analgesia after CD with less side effects

Conditions

Block

Keywords

quadratus lumborum block; cesarean section; spinal morphine; ultrasound guidance

Outcome Measures

Primary Outcomes (1)

• Total morphine consumption over 24 hours postoperatively

  Total IV morphine used when started postoperatively using a PCA with morphine in the post anesthesia care unit until 2' hours posteratively.

  Arrival to post anesthesia care unit until 24 hours posteratively

Secondary Outcomes (3)

• Time to first analgesic demand using PCA pump with morphine

  Arrival to post anesthesia care unit until 24 hours posteratively

• Visual analog scale (VAS) pain scores at rest and during the palpation of the uterine globe

  Arrival to post anesthesia care unit until 24 hours posteratively

• Time to first deambulaton after surgery

  Arrival to post anesthesia care unit until 24 hours posteratively

Study Arms (2)

spinal morphine

ACTIVE COMPARATOR

intrathecal morphine with 10 mg bupivacaine, 5 gamma sufenta and 100 gamma morphine. Intervention: In the end of surgery a QLB block is done with 20 ml of normal saline per side.

Drug: Morphine

quadratus lumborum block

ACTIVE COMPARATOR

intrathecal anesthesia with10 mg bupivacaine, 5 gamma sufena and 1 ml normal saline. Procedure : a quadratus lumborum block is done with 20 ml of bupivacaine 0,125% per side.

Drug: Quadratus lumborum block

Interventions

Morphine DRUG

spinal morphine is done before cesarean section

Also known as: spinal morphine

spinal morphine

Quadratus lumborum block DRUG

a US Block QLB is done after surgery

Also known as: QLB

quadratus lumborum block

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• ASA I/II.
• Normal singleton pregnancy with a gestation of at least 37 weeks.

You may not qualify if:

• Heart disease
• Coagulopathy
• pre-eclampsia
• BMI\> 40
• Patient refusal to undergo the Quadratus lumborum block.
• Allergy to local anesthetics

Sponsors & Collaborators

• University Tunis El Manar: lead

Study Sites (2)

Tunis maternity and neonatology center, minisetry of public health

Tunis, 1007, Tunisia

Location

Tunis maternity and neonatology center,

Tunis, 1007, Tunisia

Location

MeSH Terms

Conditions

Bites and Stings

Interventions

Morphine

Condition Hierarchy (Ancestors)

Poisoning; Chemically-Induced Disorders; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Hayene Maghrebi, Professor

  tunis maternity center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, assistant professor

Study Record Dates

• First Submitted: February 5, 2018
• First Posted: February 12, 2018
• Study Start: February 15, 2017
• Primary Completion: September 30, 2017
• Study Completion: October 20, 2017
• Last Updated: February 14, 2018

Record last verified: 2018-02

Locations

TU (2)