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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

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

Condition or disease Intervention/treatment Phase
Block Drug: Morphine Drug: Quadratus lumborum block Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Ultrasound Guided Quadratus Lumborum Type III Block Versus Intrathecal Morphine for Analgesia After Cesarean Delivery
Actual Study Start Date : February 15, 2017
Actual Primary Completion Date : September 30, 2017
Actual Study Completion Date : October 20, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Drug: Morphine
spinal morphine is done before cesarean section
Other Name: spinal 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.

Drug: Quadratus lumborum block
a US Block QLB is done after surgery
Other Name: QLB




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. 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.

  3. 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.



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03428880


Locations
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Tunisia
Tunis maternity and neonatology center, minisetry of public health
Tunis, Tunisia, 1007
Tunis maternity and neonatology center,
Tunis, Tunisia, 1007
Sponsors and Collaborators
University Tunis El Manar
Investigators
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Study Chair: Hayene Maghrebi, Professor tunis maternity center

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Responsible Party: Ben marzouk Sofiene, MD, assistant professor, University Tunis El Manar
ClinicalTrials.gov Identifier: NCT03428880    
Other Study ID Numbers: fel-bich
First Posted: February 12, 2018    Key Record Dates
Last Update Posted: February 14, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ben marzouk Sofiene, University Tunis El Manar:
quadratus lumborum block
cesarean section
spinal morphine
ultrasound guidance
Additional relevant MeSH terms:
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Morphine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents