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Quadratus Lumborum in Cesarean Section Trial (QUALICS)

13. september 2018 opdateret af: Hermann dos Santos Fernandes, University of Sao Paulo General Hospital

Comparison Between Intrathecal Morphine and Quadratus Lumborum Block for Postpartum Analgesia of Elective Cesareans.

Postoperative pain of a caesarean section may be of high intensity, especially in the first 48 hours after the procedure, which affects the mother / newborn relationship, in addition to having the potential to progress to chronic pain. The use of intrathecal morphine is effective in post-caesarean analgesia, but carries unwanted side effects, including nausea, vomiting, urinary retention and pruritus. Therefore, alternative techniques of analgesia become necessary.

First described in 2007, ultrasound-guided quadratus lumborum (QL) block has gained prominence due to its analgesic superiority to the TAP block. Besides providing somatic analgesia, it also seems to inhibit visceral pain because the local anesthetic reaches the paravertebral space, this was observed by magnetic resonance imaging with contrast medium injected at the QL block site.

Studieoversigt

Status

Ukendt

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

C-section is one of the most performed surgical procedures in the world, and presents great potential for postoperative pain, especially in the first 48 hours. Pain in this period represents a risk for evolution to chronic pain, but its incidence is still very divergent when comparing the studies, ranging from 1% to 18%.

The use of intrathecal morphine (MIT) is consecrated as a first-choice method of analgesia for post-partum cesarean delivery; however, its use carries relevant side effects for the puerpera, such as pruritus, nausea, urinary retention and , more rarely, respiratory depression. In the last decade, new adjunctive forms of postoperative analgesia have become more popular, such as regional blockades, highlighting the blockage of the Transversus Abdominis plane block (TAP) and the Quadratus Lumborum block (QL), taking as benefits the prolonged analgesia they provide and the low incidence of side effects. Another factor that contributes to the popularization of regional blocks is the increasing availability of ultrasound devices in the anesthetic-surgical environment. Studies evaluating TAP block after cesarean section performed under spinal anesthesia have shown a discrete benefit in decreasing postoperative opioid consumption in addition to improving pain scores. When comparing MIT with TAP block, the superiority of MIT is due to visceral analgesia while TAP block is restricted to abdominal wall analgesia.

Ultrasound-guided Lumbar Quadrant blockade has gained prominence due to its analgesic superiority over the TAP block, because in addition to providing somatic analgesia it also seems to inhibit visceral pain since the local anesthetic reaches the paravertebral space, this was observed by magnetic resonance imaging with contrast injected at the site of the QL block.

Reviewing the literature in 2018, there are no clinical trials comparing the use of intrathecal morphine with the quadratus lumborum block.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

75

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

      • São Paulo, Brasilien, 05403000
        • Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Kvinde

Beskrivelse

Inclusion Criteria:

  • Minimum age of 18 years
  • Minimum gestational age of 37 weeks with a single fetus
  • Patients scheduled for elective cesarean section

Exclusion Criteria:

  • Clinical contraindication to spinal anesthesia
  • Morbid obesity (BMI> 35kg / m²)
  • Drug addiction
  • Chronic use of opioids or benzodiazepines
  • Inability to understand or handle the PCA pump
  • Allergy to any medication included in the protocol

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Støttende pleje
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Tredobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Placebo komparator: Classical spinal anesthesia
Patients allocated to this group will receive spinal anesthesia with bupivacaine 12.5mg, Fentanyl 20mcg and Morphine 80mcg + placebo quadratus lumborum block.
Instead of using morphine in the classical spinal anaesthesia we will be performing in the experimental group the Quadratus Lumborum Block
Andre navne:
  • Remove morphine from the spinal block
Eksperimentel: Spinal anaesthesia with block
Patients allocated to this group will receive spinal anesthesia with bupivacaine 12.5mg, Fentanyl 20mcg + quadratus lumborum block.
Instead of using morphine in the classical spinal anaesthesia we will be performing in the experimental group the Quadratus Lumborum Block
Andre navne:
  • Remove morphine from the spinal block
Eksperimentel: Classical anaesthesia plus block
Patients allocated to this group will receive spinal anesthesia with bupivacaine 12.5mg, Fentanyl 20mcg and Morphine 80mcg + quadratus lumborum block.
Instead of using morphine in the classical spinal anaesthesia we will be performing in the experimental group the Quadratus Lumborum Block
Andre navne:
  • Remove morphine from the spinal block

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Morphine consumption
Tidsramme: 24 hours
Evaluate pain in the postoperative period with to the consumption of morphine through PCA (patient controlled analgesia) pump.
24 hours
Pain intensity
Tidsramme: 24 hours
Verbal numeric scale
24 hours

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Nausea and Vomiting
Tidsramme: 24 hours
Evaluate the incidence of nausea and vomiting between the groups through referred nausea scale from none, mild, moderate or severe.
24 hours
Pruritus
Tidsramme: 24 hours
Evaluate the incidence of pruritus between the groups through pruritus referred scale from none, mild, moderate or severe.
24 hours
Chronic pain
Tidsramme: 3 months
Evaluate the incidence of chronic pain between the groups through patient referred presence or absence of pain.
3 months
Urinary retention
Tidsramme: 24 hours
Evaluate the incidence of urinary retention between the groups through patient referred presence or absence of urinary retention.
24 hours

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Ledende efterforsker: Hermann S Fernandes, MD, University of Sao Paulo

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

18. marts 2018

Primær færdiggørelse (Forventet)

1. marts 2019

Studieafslutning (Forventet)

1. juni 2019

Datoer for studieregistrering

Først indsendt

3. september 2018

Først indsendt, der opfyldte QC-kriterier

13. september 2018

Først opslået (Faktiske)

17. september 2018

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

17. september 2018

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

13. september 2018

Sidst verificeret

1. september 2018

Mere information

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Kliniske forsøg med Postoperativ analgesi

Kliniske forsøg med Quadratus Lumborum Block

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