Quadratus Lumborum Block (QLB) for Pain Relief After Caesarean Section

Quadratus Lumborum Block (QLB) for Pain Relief After Caesarean Section: A Prospective, Double-blind, Randomised Controlled Trial.

There is currently a gap in the literature with regards to the utility of the QLB performed in conjunction with intrathecal morphine (ITM) for Caesarean section. The aim of the study is to assess the efficacy of the QLB as part of a multi-modal analgesic approach in patients after caesarean section.

Study Overview

• Status: Completed
• Conditions: Quadratus Lumborum Block
• Intervention / Treatment: Procedure: Quadratus lumborum block; Procedure: Sham QLB

Detailed Description

Post-operative pain relief management remains challenging after Caesarean-section. The perfect postoperative analgesic regimen is yet to be elucidated, but opioids remain a cornerstone whether they are administered intra-thecally, or systemically or both. Unfortunately, opioids are associated with significant adverse effects such as respiratory depression, post-operative nausea and vomiting (PONV), sedation and pruritus. Therefore, the search for opioid sparing analgesic techniques is important.

The study treatment consists of a quadratus lumborum block (QLB) of either 0.25% Levobupivacaine or a simulated sham QLB after C-section under spinal anaesthesia. The participants will be randomized into one of two groups with an internet based randomisation tool, and then allocated to either group as per the allocation in a sealed opaque envelope.

Spinal anaesthesia will be performed in a standardised manner using 10-15mg hyperbaric bupivacaine, 20ug fentanyl and 100ug preservative free morphine. Anaesthetic and surgical management will be conducted as per the usual manner. Diclofenac 100mg suppositories and IV Paracetamol 1g will be administered at the end of surgery. A Morphine PCA will be connected to the patient in the recovery room after the intervention.

The bilateral posterior QLB will be performed after surgery in the supine position in an aseptic manner. The patient will be blinded to the group intervention as the sterile drapes will be left hanging blocking the patient's view of the procedure. The block from the spinal anaesthetic will mean the patient is unaware of the procedure being carried out. A curvilinear ultrasound probe will be used to identify the quadratus lumborum muscle.

Intervention group:

Aseptic, ultrasound guided, bilateral QLB using a posterior approach. This is known as the QLB 2 approach. A maximum volume of 20 ml of 0.25% Levobupivacaine will be administered each side. After the procedure a sterile dressing will be placed on the puncture site.

Placebo group:

The patient will be sterilized, draped and scanned in the same manner as the intervention group, until the target injection point is identified. The operator will use a blunt needle to apply pressure to the skin, (without breaking the skin), for one minute as if they are performing the procedure. This will be performed bilaterally. After the procedure, a sterile dressing will be placed over the pressure area.

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Ireland
  • Dublin, Ireland, 00000
    • Coombe Women and Infants University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Elective Caesarean section under spinal anaesthesia.
• Age > 18 years old.
• Singleton pregnancy.

Exclusion Criteria:

• Contraindication to spinal or regional anaesthesia.
• Allergy/sensitivity/contraindication to study medications.
• Unable to comprehend visual analogue scale.
• BMI > 40.
• Booking weight <40kg.
• History of chronic pain or regular opioid use.
• Pre-eclampsia.

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: Quadratus lumborum block; Bilateral posterior QLB with 20ml 0.25% L-Bupivacaine.	Procedure: Quadratus lumborum block; Ultrasound guided Quadratus Lumborum block using a posterior approach. (QLB 2)
Sham Comparator: Sham QLB; Sham QLB - Ultrasound identification of QLB followed by skin pressure with blunt needle. Patient blinded due to residual spinal anaesthetic block.	Procedure: Sham QLB; Sham QLB - Ultrasound identification of QLB followed by skin pressure with blunt needle.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
IV PCA Morphine consumption up to 24 hours.	Intravenous PCA (patient controlled analgesia) morphine consumption up to 24 hours.	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain scores at rest.	VAS (visual analogue scale) pain scores at rest - lying supine in bed.	6, 12, 24, 48 hours
Pain scores on movement.	VAS pain scores on movement - raising head and shoulders off pillow when lying supine in bed.	6, 12, 24, 48 hours
Nausea and vomiting.	The incidence of N+V requiring rescue anti-emetics.	24, 48 hours
IV PCA morphine bolus demands.	Intravenous PCA (patient controlled analgesia) morphine bolus demands up to 24 hours.	24 hours
Total opioid consumption at 48 hours.	Total opioid consumption at 48 hours - converted to IV morphine equivalents.	48 hours
QbsQoR-11.	Quality of Recovery questionnaire.	24, 48 hours
QoR-15.	Quality of Recovery questionnaire.	24, 48 hours

Collaborators and Investigators

• Sponsor: Coombe Women and Infants University Hospital
• Investigators: Principal Investigator: Terry Tan, Head of Department of Anaesthesia CWIUH

Study record dates

Study Major Dates

• Study Start (Actual): October 30, 2018
• Primary Completion (Actual): April 24, 2019
• Study Completion (Actual): April 24, 2019

Study Registration Dates

• First Submitted: October 1, 2018
• First Submitted That Met QC Criteria: October 3, 2018
• First Posted (Actual): October 4, 2018

Study Record Updates

• Last Update Posted (Actual): July 23, 2019
• Last Update Submitted That Met QC Criteria: July 22, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: pain relief; analgesia; Cesarean; Caesarean; intrathecal morphine; QLB; c-section; QL; QLB2; QL2
• Other Study ID Numbers: CWIUH-QLB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

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