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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03428880
Recruitment Status : Completed
First Posted : February 12, 2018
Last Update Posted : February 14, 2018
Sponsor:
Information provided by (Responsible Party):
Ben marzouk Sofiene, University Tunis El Manar

Tracking Information
First Submitted Date  ICMJE February 5, 2018
First Posted Date  ICMJE February 12, 2018
Last Update Posted Date February 14, 2018
Actual Study Start Date  ICMJE February 15, 2017
Actual Primary Completion Date September 30, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 5, 2018)
Total morphine consumption over 24 hours postoperatively [ Time Frame: Arrival to post anesthesia care unit until 24 hours posteratively ]
Total IV morphine used when started postoperatively using a PCA with morphine in the post anesthesia care unit until 2' hours posteratively.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 5, 2018)
  • Time to first analgesic demand using PCA pump with morphine [ Time Frame: Arrival to post anesthesia care unit until 24 hours posteratively ]
    recording the exact time to first analgesic demand by using the PCA with Morphine
  • Visual analog scale (VAS) pain scores at rest and during the palpation of the uterine globe [ Time Frame: Arrival to post anesthesia care unit until 24 hours posteratively ]
    At predetermined intervalls, visual analog scale (VAS) pain scores at rest and at the palpation of the uterine globe were noted.
  • Time to first deambulaton after surgery [ Time Frame: Arrival to post anesthesia care unit until 24 hours posteratively ]
    After surgery, time when the patient was able to move from bed was noted.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ultrasound Guided QLB III Versus Intrathecal Morphine for Analgesia After Cesarean Section
Official Title  ICMJE Ultrasound Guided Quadratus Lumborum Type III Block Versus Intrathecal Morphine for Analgesia After Cesarean Delivery
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
Detailed Description

In this prospective double blinded randomized study,120 parturients undergoing cesarian delivery via a Pfannenstiel incision and who agreed to spinal anesthesia were randomly scheduled to receive either a SAM (group SAM, n=60) or a Quadratus lumborum block type 3 (group QLB, n=60).Spinal anesthesia was initiated with hyperbaric Bupivacaïne 0.5% 10 mg, 0,005 mg SUFENTANIL MEDIS and 0.1 mg morphine in the SAM group and with Bupivacaïne 0.5% 10 mg, 0,005 mg SUFENTANIL MEDIS and 1 ml normal saline in group QLB.

After surgery, bilateral QLB block type 3 was performed with the patient in lateral position using bupivacaine 0.25% , 20 mL on each side in group QLB and 20 ml normal saline in group SAM.

Postoperative analgesia for the first 24 hours consisted of a patient controlled analgesia with IV morphine only. If necessary breakthrough pain was treated by 01 g paracetamol intravenously by the same doctor in charge of taking the values of the visual analogue scale.

Patients were assessed postoperatively in the postanesthesia care unit (time 0 hours) and at 2, 4, 6, 12 and 24 hours.

Visual analogue scale (VAS) for pain at rest and during the palpation of the uterine globe was noted.

The primary outcome measure was the total dose of morphine over 24 hours delivered by a patient-controlled analgesia system at predetermined intervals.

Secondary outcomes were visual analogue scale (VAS) for pain at rest and on the palpation of the uterine globe ,heart rate, blood pressure, itching, nausea, pruritus, vomiting and sedation.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Block
Intervention  ICMJE
  • Drug: Morphine
    spinal morphine is done before cesarean section
    Other Name: spinal morphine
  • Drug: Quadratus lumborum block
    a US Block QLB is done after surgery
    Other Name: QLB
Study Arms  ICMJE
  • Active Comparator: spinal morphine
    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.
    Intervention: Drug: Morphine
  • Active Comparator: quadratus lumborum block

    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.

    Intervention: Drug: Quadratus lumborum block
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 5, 2018)
120
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 20, 2017
Actual Primary Completion Date September 30, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

  • Heart disease
  • Coagulopathy
  • pre-eclampsia
  • BMI> 40
  • Patient refusal to undergo the Quadratus lumborum block.
  • Allergy to local anesthetics
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Tunisia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03428880
Other Study ID Numbers  ICMJE fel-bich
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Ben marzouk Sofiene, University Tunis El Manar
Study Sponsor  ICMJE University Tunis El Manar
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Hayene Maghrebi, Professor tunis maternity center
PRS Account University Tunis El Manar
Verification Date February 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP