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

NCT ID: NCT03695588

Last Updated: 2019-07-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-30
• Study Completion Date: 2019-04-24

Brief Summary

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.

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.

Conditions

Quadratus Lumborum Block

Study Design

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

Study Groups

Quadratus lumborum block

Bilateral posterior QLB with 20ml 0.25% L-Bupivacaine.

Group Type: ACTIVE_COMPARATOR

Quadratus lumborum block

Intervention Type: PROCEDURE

Ultrasound guided Quadratus Lumborum block using a posterior approach. (QLB 2)

Sham QLB

Sham QLB - Ultrasound identification of QLB followed by skin pressure with blunt needle. Patient blinded due to residual spinal anaesthetic block.

Group Type: SHAM_COMPARATOR

Sham QLB

Intervention Type: PROCEDURE

Sham QLB - Ultrasound identification of QLB followed by skin pressure with blunt needle.

Interventions

Quadratus lumborum block

Ultrasound guided Quadratus Lumborum block using a posterior approach. (QLB 2)

Intervention Type: PROCEDURE

Sham QLB

Sham QLB - Ultrasound identification of QLB followed by skin pressure with blunt needle.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Coombe Women and Infants University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Ruairi Irwin

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Terry Tan

Role: PRINCIPAL_INVESTIGATOR

Head of Department of Anaesthesia CWIUH

Locations

Coombe Women and Infants University Hospital

Dublin, , Ireland

Countries

Ireland

Other Identifiers

CWIUH-QLB

Identifier Type: -

Identifier Source: org_study_id