Comparison of Intrathecal Morphine With the Quadratus Lumborum Type 2 Block for Post-operative Analgesia Following Elective Caesarean Section (QLBvITM Study)

NCT03267628 | Withdrawn

• 1 other identifier: HREC/17/QPCH/121
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The investigators are comparing post operative analgesia provided for caesarean section patients, with the quadratus lumborum type 2 block and intrathecal morphine.

Conditions

Cesarean Section; Pain, Acute

Keywords

intrathecal morphine; quadratus lumborum type 2 block; cesarean section; pain

Outcome Measures

Primary Outcomes (1)

• 24 hours total intravenous morphine usage via a PCA pump

  Post operative intravenous morphine use will be noted at 24 hours post cesarean section

  24 hours

Secondary Outcomes (2)

• Patient's side effects within the 24 hours post operative period.

  24 hours

• Pain Scores within 24 hours post operative period.

  24 hours

Study Arms (4)

Saline intrathecal as well as saline in Blocks

SHAM COMPARATOR

These 25 patients will receive 0.3ml saline added to the spinal anaesthetic and 25 ml saline both sides as a QLB2.

Procedure: Saline intrathecal as well as saline in Blocks; Procedure: Saline intrathecal as well as local anaesthetic in Blocks

Saline intrathecal as well as local anaesthetic in Blocks

ACTIVE COMPARATOR

These 25 patients will receive 0.3ml saline added to the spinal anaesthetic and 25 ml local anaesthetic both sides as a QLB2.

Procedure: Intrathecal morphine as well as local anaesthetic in Blocks; Procedure: Saline intrathecal as well as saline in Blocks

Intrathecal morphine as well as local anaesthetic in Blocks

ACTIVE COMPARATOR

These 25 patients will receive 0.3ml (150mcg) morphine added to the spinal anaesthetic and 25 ml local anaesthetic both sides as a QLB2.

Procedure: Intrathecal morphine as well as local anaesthetic in Blocks; Procedure: Intrathecal morphine as well as saline in Block

Intrathecal morphine as well as saline in Block

ACTIVE COMPARATOR

These 25 patients will receive 0.3ml (150mcg) morphine added to the spinal anaesthetic and 25 ml saline both sides as a QLB2.

Procedure: Intrathecal morphine as well as saline in Block; Procedure: Saline intrathecal as well as local anaesthetic in Blocks

Interventions

Intrathecal morphine as well as local anaesthetic in Blocks PROCEDURE

A Quadratus lumborum type 2 block will be performed under ultrasound with 25 ml 0.375% ropivacaine deposited posterior to the quadratus lumborum muscle. 150mcg morphine will be added to the spinal anaesthetic.

Intrathecal morphine as well as local anaesthetic in Blocks; Saline intrathecal as well as local anaesthetic in Blocks

Intrathecal morphine as well as saline in Block PROCEDURE

150mcg morphine will be added to the spinal anaesthetic. 25 ml saline will be used on each side during a quadratus lumborum type 2 block.

Intrathecal morphine as well as local anaesthetic in Blocks; Intrathecal morphine as well as saline in Block

Saline intrathecal as well as saline in Blocks PROCEDURE

0.3 ml saline will be added to the spinal anaesthetic. 25 ml saline will be used on each side during a quadratus lumborum type 2 block.

Saline intrathecal as well as local anaesthetic in Blocks; Saline intrathecal as well as saline in Blocks

Saline intrathecal as well as local anaesthetic in Blocks PROCEDURE

0.3 ml saline will be added to the spinal anaesthetic. A Quadratus lumborum type 2 block will be performed under ultrasound with 25 ml 0.375% ropivacaine deposited posterior to the quadratus lumborum muscle.

Intrathecal morphine as well as saline in Block; Saline intrathecal as well as saline in Blocks

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: Female patients undergoing elective cesarean sections
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Anaesthetist trained in QLB and ITM techniques available
• American Society of Anaesthesiologists PS category client I or II
• years of age or older
• Ability to read and understand English
• Uncomplicated pregnancy at term (\>37 weeks completed gestation)
• Booked elective CS

You may not qualify if:

• Contraindications to spinal anaesthesia
• History of chronic opioid consumption / chronic pain conditions
• Known allergy to study drugs
• Weight more than 95kg or body mass index (BMI) more than 35 pre operative
• Placenta Previa / accreta
• Obstructive Sleep apnoea
• Severe asthma unable to tolerate Non steroidal anti inflammatory agents

Sponsors & Collaborators

• Dr Willem Basson: lead
• Sunshine Coast Hospital and Health Service: collaborator

MeSH Terms

Conditions

Acute Pain; Pain

Interventions

Anesthesia, Local; Dental Occlusion; Sodium Chloride

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia; Dentistry; Dental Physiological Phenomena; Digestive System and Oral Physiological Phenomena; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Willem Basson, FANZCA

  Sunshine Coast University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double blinded
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Staff Specialist in Anaesthetics

Model Details: 4 groups of 25 patients each. All patients will receive a spinal and a quadratus lumborum type 2 block. The groups will have a combination of ITM / QLB or both or neither.

Study Record Dates

• First Submitted: August 10, 2017
• First Posted: August 30, 2017
• Study Start: January 1, 2019
• Primary Completion: November 1, 2019
• Study Completion: December 31, 2019
• Last Updated: April 17, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share