Clinical trial NCT03428880: Ultrasound Guided QLB III Versus Intrathecal Morphine for Analgesia After Cesarean Section
Official title: Ultrasound Guided Quadratus Lumborum Type III Block Versus Intrathecal Morphine for Analgesia After Cesarean Delivery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Block
Keywords: quadratus lumborum block
cesarean section
spinal morphine
ultrasound guidance
Lead sponsor: University Tunis El Manar
Sponsor class: OTHER
First posted: 2018-02-12
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Total morphine consumption over 24 hours postoperatively
timeFrame: Arrival to post anesthesia care unit until 24 hours posteratively
Secondary outcomes:
measure: Time to first analgesic demand using PCA pump with morphine
timeFrame: Arrival to post anesthesia care unit until 24 hours posteratively
measure: Visual analog scale (VAS) pain scores at rest and during the palpation of the uterine globe
timeFrame: Arrival to post anesthesia care unit until 24 hours posteratively
measure: Time to first deambulaton after surgery
timeFrame: Arrival to post anesthesia care unit until 24 hours posteratively
Other outcomes:
Locations:
city: Tunis
country: Tunisia
facility: Tunis maternity and neonatology center, minisetry of public health
city: Tunis
country: Tunisia
facility: Tunis maternity and neonatology center,
Study officials:
affiliation: tunis maternity center
name: Hayene Maghrebi, Professor
role: STUDY_CHAIR
References: