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

U

University Tunis El Manar

Status and phase

Completed
Phase 4

Conditions

Block

Treatments

Drug: Quadratus lumborum block
Drug: Morphine

Study type

Interventional

Funder types

Other

Identifiers

NCT03428880
fel-bich

Details and patient eligibility

About

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

Full 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.

Enrollment

120 patients

Sex

Female

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

120 participants in 2 patient groups

spinal morphine
Active Comparator group
Description:
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.
Treatment:
Drug: Morphine
quadratus lumborum block
Active Comparator group
Description:
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.
Treatment:
Drug: Quadratus lumborum block

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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