Fixed-Mass Different Volumes Bupivacaine TAP Block After Cesarean
Ultrasound-guided Transversus Abdominis Plane Block After Cesarean Section Using Two Different Bupivacaine Volumes With a Fixed Drug Mass. A Randomized Comparative Trial.
Cesarean section is commonly associated with moderate to severe postoperative pain, which may delay mobilisation, impair breastfeeding, and affect mother-infant bonding. Although opioids, NSAIDs, and neuraxial techniques are commonly used for post-cesarean analgesia, their side effects have encouraged the use of peripheral nerve blocks such as the transversus abdominis plane block.
The TAP block is a fascial plane block that provides analgesia by depositing local anaesthetic between the internal oblique and transversus abdominis muscles. Its efficacy after cesarean section has been demonstrated, particularly when long-acting intrathecal opioids are not used. However, the optimal local anaesthetic volume and dose remain unclear. Since the TAP block depends on adequate spread of local anaesthetic, larger volumes may improve analgesic coverage, but increasing the dose may raise the risk of systemic toxicity.
Therefore, this study investigates whether using the same fixed mass of bupivacaine in two different volumes affects the analgesic efficacy of TAP block after cesarean section, hypothesising that the larger volume may provide better postoperative analgesia.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Antatt)
Fase
- Fase 4
Kontakter og plasseringer
Studiekontakt
- Navn: Abeer Ahmed, MD
- Telefonnummer: +201005244590
- E-post: abeer_ahmed@kasralainy.edu.eg
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Beskrivelse
Inclusion Criteria:
- full-term parturients,
- aged > 18 years
- ASA physical status II
- patients who are scheduled for elective CS with Pfannenstiel incisions under spinal anaesthesia.
Exclusion Criteria:
- Parturients with contraindications to spinal anaesthesia,
- Having a scar or infection at the site of the block
- BMI > 35 Kg/m2,
- on chronic use of pain medications,
- Refusing to participate.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Trippel
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Fixed-mass, high-volume bupivacaine TAP block
Participants will receive a bilateral ultrasound-guided TAP block using 150 mg of plain bupivacaine, diluted to a total volume of 60 mL, injected as 30 mL per side.
|
Ultrasound-guided bilateral transversus abdominis plane block using 150 mg plain bupivacaine after cesarean section.
The same total bupivacaine dose will be administered in two different volumes: 60 mL total volume, 30 mL per side
Ultrasound-guided bilateral transversus abdominis plane block using 150 mg plain bupivacaine after cesarean section.
The same total bupivacaine dose will be administered in two different volumes: 120 mL total volume, 60 mL per side.
|
|
Eksperimentell: Fixed-mass, low-volume bupivacaine TAP block
Participants will receive a bilateral ultrasound-guided TAP block using 150 mg of plain bupivacaine, diluted to a total volume of 120 mL, injected as 60 mL per side.
|
Ultrasound-guided bilateral transversus abdominis plane block using 150 mg plain bupivacaine after cesarean section.
The same total bupivacaine dose will be administered in two different volumes: 60 mL total volume, 30 mL per side
Ultrasound-guided bilateral transversus abdominis plane block using 150 mg plain bupivacaine after cesarean section.
The same total bupivacaine dose will be administered in two different volumes: 120 mL total volume, 60 mL per side.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
total postoperative morphine consumption
Tidsramme: first 24 hours postoperatively
|
first 24 hours postoperatively
|
Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- MD-185-2023
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
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