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

NCT ID: NCT03428880

Last Updated: 2018-02-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-15
• Study Completion Date: 2017-10-20

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.

Conditions

Block

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Morphine

Intervention Type: DRUG

spinal morphine is done before cesarean section

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.

Group Type: ACTIVE_COMPARATOR

Quadratus lumborum block

Intervention Type: DRUG

a US Block QLB is done after surgery

Interventions

Morphine

spinal morphine is done before cesarean section

Intervention Type: DRUG

Quadratus lumborum block

a US Block QLB is done after surgery

Intervention Type: DRUG

Other Intervention Names

spinal morphine; QLB

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University Tunis El Manar

OTHER

Sponsor Role: lead

Responsible Party

Ben marzouk Sofiene

MD, assistant professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hayene Maghrebi, Professor

Role: STUDY_CHAIR

tunis maternity center

Locations

Tunis maternity and neonatology center, minisetry of public health

Tunis, , Tunisia

Tunis maternity and neonatology center,

Tunis, , Tunisia

Countries

Tunisia

Other Identifiers

fel-bich

Identifier Type: -

Identifier Source: org_study_id