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

15. april 2019 oppdatert av: Dr Willem Basson

Quadratus Lumborum Type 2 Block Versus Intrathecal Morphine for Analgesia Following Elective Caesarean Sections

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

Studieoversikt

Status

Tilbaketrukket

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Fase

  • Ikke aktuelt

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 50 år (Voksen)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

Hunn

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Støttende omsorg
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Firemannsrom

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Sham-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.
Fremgangsmåte: Saline intrathecal as well as saline in Blocks
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.
Fremgangsmåte: Saline intrathecal as well as local anaesthetic in Blocks
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.
Aktiv 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.
Fremgangsmåte: Saline intrathecal as well as saline in Blocks
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.
Fremgangsmåte: Intrathecal morphine as well as local anaesthetic in Blocks
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.
Aktiv 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.
Fremgangsmåte: Intrathecal morphine as well as local anaesthetic in Blocks
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.
Fremgangsmåte: Intrathecal morphine as well as saline in Block
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.
Aktiv 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.
Fremgangsmåte: Saline intrathecal as well as local anaesthetic in Blocks
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.
Fremgangsmåte: Intrathecal morphine as well as saline in Block
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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
24 hours total intravenous morphine usage via a PCA pump
Tidsramme: 24 hours
Post operative intravenous morphine use will be noted at 24 hours post cesarean section
24 hours

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Patient's side effects within the 24 hours post operative period.
Tidsramme: 24 hours
Nausea, vomiting, itching, herpes reactivation, urinary retention and sedation will be noted.
24 hours
Pain Scores within 24 hours post operative period.
Tidsramme: 24 hours
Using a VAS we will note both dynamic and static pain scores at 24 hours post operative
24 hours

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Dr Willem Basson

Samarbeidspartnere

Sunshine Coast Hospital and Health Service

Etterforskere

  • Hovedetterforsker: Willem Basson, FANZCA, Sunshine Coast University Hospital

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Forventet)

1. januar 2019

Primær fullføring (Forventet)

1. november 2019

Studiet fullført (Forventet)

31. desember 2019

Datoer for studieregistrering

Først innsendt

10. august 2017

Først innsendt som oppfylte QC-kriteriene

28. august 2017

Først lagt ut (Faktiske)

30. august 2017

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

17. april 2019

Siste oppdatering sendt inn som oppfylte QC-kriteriene

15. april 2019

Sist bekreftet

1. april 2019

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • HREC/17/QPCH/121

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

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Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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