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

Ultrasound Guided Quadratus Lumborum Type III Block Versus Intrathecal Morphine for Analgesia After Cesarean Delivery

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

Study Overview

• Status: Completed
• Conditions: Block
• Intervention / Treatment: Drug: Morphine; Drug: Quadratus lumborum block

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 Type: Interventional
• Enrollment (Actual): 120
• Phase: Phase 4

Contacts and Locations

Study Locations

• Tunisia
  • Tunis, Tunisia, 1007
    • Tunis maternity and neonatology center,
  • Tunis, Tunisia, 1007
    • Tunis maternity and neonatology center, minisetry of public health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total morphine consumption over 24 hours postoperatively	Total IV morphine used when started postoperatively using a PCA with morphine in the post anesthesia care unit until 2' hours posteratively.	Arrival to post anesthesia care unit until 24 hours posteratively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to first analgesic demand using PCA pump with morphine	recording the exact time to first analgesic demand by using the PCA with Morphine	Arrival to post anesthesia care unit until 24 hours posteratively
Visual analog scale (VAS) pain scores at rest and during the palpation of the uterine globe	At predetermined intervalls, visual analog scale (VAS) pain scores at rest and at the palpation of the uterine globe were noted.	Arrival to post anesthesia care unit until 24 hours posteratively
Time to first deambulaton after surgery	After surgery, time when the patient was able to move from bed was noted.	Arrival to post anesthesia care unit until 24 hours posteratively

Collaborators and Investigators

• Sponsor: University Tunis El Manar
• Investigators: Study Chair: Hayene Maghrebi, Professor, tunis maternity center

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2017
• Primary Completion (Actual): September 30, 2017
• Study Completion (Actual): October 20, 2017

Study Registration Dates

• First Submitted: February 5, 2018
• First Submitted That Met QC Criteria: February 5, 2018
• First Posted (Actual): February 12, 2018

Study Record Updates

• Last Update Posted (Actual): February 14, 2018
• Last Update Submitted That Met QC Criteria: February 12, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: cesarean section; quadratus lumborum block; ultrasound guidance; spinal morphine
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Morphine
• Other Study ID Numbers: fel-bich

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No