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

Sponsor
University Tunis El Manar (Other)
Overall Status
Completed
CT.gov ID
NCT03428880
Collaborator
(none)
120
2
2
8.1
60
7.4

Study Details

Study Description

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
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.

Study Design

Study Type:
Interventional
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 :
Feb 15, 2017
Actual Primary Completion Date :
Sep 30, 2017
Actual Study Completion Date :
Oct 20, 2017

Arms and Interventions

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 Names:
  • 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 Names:
  • QLB
  • Outcome Measures

    Primary Outcome Measures

    1. Total morphine consumption over 24 hours postoperatively [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 [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 [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 [Arrival to post anesthesia care unit until 24 hours posteratively]

      After surgery, time when the patient was able to move from bed was noted.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 45 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Tunis maternity and neonatology center, minisetry of public health Tunis Tunisia 1007
    2 Tunis maternity and neonatology center, Tunis Tunisia 1007

    Sponsors and Collaborators

    • University Tunis El Manar

    Investigators

    • Study Chair: Hayene Maghrebi, Professor, tunis maternity center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ben marzouk Sofiene, MD, assistant professor, University Tunis El Manar
    ClinicalTrials.gov Identifier:
    NCT03428880
    Other Study ID Numbers:
    • fel-bich
    First Posted:
    Feb 12, 2018
    Last Update Posted:
    Feb 14, 2018
    Last Verified:
    Feb 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Ben marzouk Sofiene, MD, assistant professor, University Tunis El Manar
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Feb 14, 2018