- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT03267628
Comparison of Intrathecal Morphine With the Quadratus Lumborum Type 2 Block for Post-operative Analgesia Following Elective Caesarean Section (QLBvITM Study)
Quadratus Lumborum Type 2 Block Versus Intrathecal Morphine for Analgesia Following Elective Caesarean Sections
Studienübersicht
Status
Bedingungen
Detaillierte Beschreibung
In Australia the rate of birth via caesarean section (CS) has significantly increased over the last twenty years. Improvements in the care of women undergoing CS are important locally, nationally and internationally. Compared to women birthing vaginally, women undergoing CS experience more adverse events and more pain. Effective pain relief following CS is important as it enables early ambulation, encourages maternal bonding, and promotes breastfeeding initiation and establishment. Traditional analgesic techniques following CS include opioid medications. Whist effective, the use of opioids are associated with frequent and significant side effects. Alternative analgesic agents are being explored in an attempt to improve the effectiveness of pain relief available to women and clinicians.
The quadratus lumborum block (QLB) block is an innovative regional analgesic technique. Its role as an effective analgesic agent in abdominal surgery is increasing. However, it has not been studied for pain relief in Australia after cesarean section.
In this study, the investigator aims to compare post-operative analgesia and side effects between the QLB blocks versus adding morphine the participant's spinal anaesthetic (ITM) during the elective C/S. Results from this study will provide information on the analgesic impact of this new and emerging therapy and assist in the development of a larger clinical trial.
Studientyp
Phase
- Unzutreffend
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:
- Anaesthetist trained in QLB and ITM techniques available
- American Society of Anaesthesiologists PS category client I or II
- 18 years of age or older
- Ability to read and understand English
- Uncomplicated pregnancy at term (>37 weeks completed gestation)
- Booked elective CS
Exclusion Criteria:
- 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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Unterstützende Pflege
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Vervierfachen
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
---|---|
Schein-Komparator: Saline intrathecal as well as saline in Blocks
These 25 patients will receive 0.3ml saline added to the spinal anaesthetic and 25 ml saline both sides as a QLB2.
|
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.
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.
|
Aktiver Komparator: Saline intrathecal as well as local anaesthetic in Blocks
These 25 patients will receive 0.3ml saline added to the spinal anaesthetic and 25 ml local anaesthetic both sides as a QLB2.
|
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.
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.
|
Aktiver Komparator: Intrathecal morphine as well as local anaesthetic in Blocks
These 25 patients will receive 0.3ml (150mcg) morphine added to the spinal anaesthetic and 25 ml local anaesthetic both sides as a QLB2.
|
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.
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.
|
Aktiver Komparator: Intrathecal morphine as well as saline in Block
These 25 patients will receive 0.3ml (150mcg) morphine added to the spinal anaesthetic and 25 ml saline both sides as a QLB2.
|
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.
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.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
24 hours total intravenous morphine usage via a PCA pump
Zeitfenster: 24 hours
|
Post operative intravenous morphine use will be noted at 24 hours post cesarean section
|
24 hours
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Patient's side effects within the 24 hours post operative period.
Zeitfenster: 24 hours
|
Nausea, vomiting, itching, herpes reactivation, urinary retention and sedation will be noted.
|
24 hours
|
Pain Scores within 24 hours post operative period.
Zeitfenster: 24 hours
|
Using a VAS we will note both dynamic and static pain scores at 24 hours post operative
|
24 hours
|
Mitarbeiter und Ermittler
Sponsor
Mitarbeiter
Ermittler
- Hauptermittler: Willem Basson, FANZCA, Sunshine Coast University Hospital
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Voraussichtlich)
Primärer Abschluss (Voraussichtlich)
Studienabschluss (Voraussichtlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- HREC/17/QPCH/121
Plan für individuelle Teilnehmerdaten (IPD)
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Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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