- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT03673280
Quadratus Lumborum in Cesarean Section Trial (QUALICS)
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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Förväntat)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
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São Paulo, Brasilien, 05403000
- Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Stödjande vård
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Trippel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Placebo-jämförare: 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.
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Instead of using morphine in the classical spinal anaesthesia we will be performing in the experimental group the Quadratus Lumborum Block
Andra namn:
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Experimentell: Spinal anaesthesia with block
Patients allocated to this group will receive spinal anesthesia with bupivacaine 12.5mg, Fentanyl 20mcg + quadratus lumborum block.
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Instead of using morphine in the classical spinal anaesthesia we will be performing in the experimental group the Quadratus Lumborum Block
Andra namn:
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Experimentell: 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
Andra namn:
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Morphine consumption
Tidsram: 24 hours
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Evaluate pain in the postoperative period with to the consumption of morphine through PCA (patient controlled analgesia) pump.
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24 hours
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Pain intensity
Tidsram: 24 hours
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Verbal numeric scale
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24 hours
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Nausea and Vomiting
Tidsram: 24 hours
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Evaluate the incidence of nausea and vomiting between the groups through referred nausea scale from none, mild, moderate or severe.
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24 hours
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Pruritus
Tidsram: 24 hours
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Evaluate the incidence of pruritus between the groups through pruritus referred scale from none, mild, moderate or severe.
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24 hours
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Chronic pain
Tidsram: 3 months
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Evaluate the incidence of chronic pain between the groups through patient referred presence or absence of pain.
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3 months
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Urinary retention
Tidsram: 24 hours
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Evaluate the incidence of urinary retention between the groups through patient referred presence or absence of urinary retention.
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24 hours
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Samarbetspartners och utredare
Utredare
- Huvudutredare: Hermann S Fernandes, MD, University of Sao Paulo
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Förväntat)
Avslutad studie (Förväntat)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- CAAE 90600818.0.0000.0068
Plan för individuella deltagardata (IPD)
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