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Comparative Analysis of the Impact of Transversus Abdominis Plane Block on Post-Cesarean Pain Management Using Low Concentration Ropivacaine 0,2%

17. mai 2026 oppdatert av: Matild Keresztes

The goal of this clinical trial is to evaluate whether the addition of a Transversus Abdominis Plane (TAP) block improves postoperative outcomes in women undergoing cesarean section.

The main questions it aims to answer are:

Does the TAP block reduce postoperative pain scores compared with the traditional analgesic regimen used in our hospital? Does the TAP block decrease opioid consumption within the first 24 hours? Does the TAP block improve the 24-hour quality of recovery? Researchers will compare patients receiving the traditional analgesic regimen with patients who receive the TAP block in addition to standard care to determine differences in pain management, opioid requirements, and recovery quality.

Participants will:

Receive standard anesthetic and perioperative care for cesarean delivery. Be randomized to either the TAP block group or the traditional analgesic regimen group.

Have postoperative pain scores assessed at predefined intervals. Have opioid consumption recorded within the first 24 hours. Complete a quality-of-recovery assessment at 24 hours postoperatively.

Studieoversikt

Detaljert beskrivelse

This study will evaluate the effectiveness of a Transversus Abdominis Plane (TAP) block for postoperative analgesia in patients undergoing cesarean section.

Participants randomized to the TAP group will receive an ultrasound-guided TAP block with ropivacaine 0.2% at a dose of 0.4 ml/kg per side. The block will be performed at the end of surgery, under spinal anesthesia, using a linear probe with a lateral approach. After aseptic preparation of the skin, sterile probe covering, and operator sterile technique, the muscle layers will be identified sonographically. A 50 mm or 100 mm needle will be inserted in-plane. Following confirmation of the fascial plane and negative aspiration for blood, local anesthetic will be administered in 5 ml increments, with repeated aspiration to avoid intravascular injection.

Postoperative analgesia in the TAP group will consist of ibuprofen every 8 hours (max 1200mg/day) and paracetamol every 6-8 hours (max 4 gr/day), with tramadol 50 mg available as rescue analgesic.

Participants in the control group (non-TAP) will receive the traditional analgesic regimen used in our hospital: metamizole every 8 hours ( max 3 gr/day), NSAIDs (ibuprofen, dexketoprofen, pareecoxib), paracetamol every 6-8 hours ( max 4 gr/day), and scheduled tramadol, every 8-12 hour ( max 300 mg/day)

Pain assessment and outcomes:

Participants will remain in the obstetric intensive care unit (ICU) for the first 12-24 hours after cesarean delivery, after which they will be transferred to the ward.

Pain will be assessed using the Numeric Rating Scale (NRS) at rest, during mobilization, during breastfeeding, and while standing/walking. The target NRS is ≤4.

Opioid consumption will be recorded during the first 24 hours.

Quality of recovery:

At 24 hours postoperatively, participants will complete the ObsQoR-11 questionnaire, a validated recovery tool consisting of 11 statements.

It comprises 11 items that assess recovery across the key domains of physical comfort, physical independence, psychological well-being, emotional state, and pain control.

Each item is rated by the patient on a 0-10 numerical rating scale, where 0 corresponds to the poorest recovery or complete disagreement with the statement, and 10 corresponds to the best possible recovery or complete agreement with the statement.

The individual item scores are summed to yield a total score ranging from 0 to 110, with higher scores reflecting a better quality of postoperative recovery. The ObsQoR-11 therefore provides a quantitative, standardized, and patient-centered measure of recovery, allowing for both within-group and between-group comparisons in clinical trials.

Studietype

Intervensjonell

Registrering (Antatt)

70

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

  • Navn: Janos Szederjesi, MD, PhD Assoc Prof
  • Telefonnummer: +40745316221
  • E-post: yangzi37@gmail.com

Studiesteder

    • Mureș County
      • Târgu Mureş, Mureș County, Romania, 547581
        • Rekruttering
        • County Emergency Clinical Hospital of Targu Mureș
        • Ta kontakt med:
        • Ta kontakt med:

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

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

Inclusion Criteria:

pregnant patient anaesthesia type for c-section: spinal

Exclusion Criteria:

general anaesthesia for c-section combined spinal/epidural anaethesia for c-section hipertensive emergencies in obstetrics haemorrhage emergencies in obstetrics

Studieplan

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

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: Postoperative (c-section) TAP block
Post c-section TAP block under spinal anaesthesia. Local anesthetic used in TAP block: Ropivacaine 0,2 %, dose: 0,4 ml/kg per side. Postoperative analgesia regimen: Ibuprofen every 8 hours (total dose 1200 mg/24h) and Paracetamol every 6-8 hours (total dose 4 gr/24 h). Postop analgesia score: numeric rating scale ( 0-10). Rescue analgesia if score is higher then 4: tramadol 50 mg, diluated in 20 ml NaCl 0,9%, administered slow iv ( 5 min).
Postoperative (post cesarean section) TAP block using low concentration Ropivacaine ( 0,2%), volume dose weight calculated: 0,4 ml/kg per side. Total ropivacaine dose 1,6 mg/kg.
Andre navn:
  • TAP-blokk
Annen: "Traditional" analgesia regimen after c-section
This arm receives the "traditional" analgesia regimen used in our hospital. This analgesia consist of: metamizol 1 gr every 8 hours, paracetamol 1gr every 8 hours, Ibuprofen every 8 hours or dexketoprofen 50 mg every 12 hours or parecoxib 40 mg every 12 hours. The use of NSAID are not mandatory and is doctor dependent. In the traditional analgesia regime we have regular opioids: tramadol 100 mg every 8-12 hours. We assess the pain scores using numeric rating scale (0-10). If pain persist usually rescue analgesia is a second opiod: meperidine 15-20 mg iv.
"Traditional" analgesia refers to our analgesia technique used in our hospital. Regular Tramadol, Metamizol, +/- Ibuprofen/Dexketorpofen/Parecoxib

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
Postoperative opioid consumption
Tidsramme: 24 hours
24 hours

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Recovery after cesarean section using the ObsQoR-11
Tidsramme: 24 hours
The ObsQoR-11 is an 11-item, self-report questionnaire used to assess recovery after childbirth, particularly caesarean delivery after 24 hours. It measures four key aspects of recovery: physical comfort, emotional state, physical independence, and the ability to care for the newborn. A higher ObsQoR-11 score indicates better recovery
24 hours

Samarbeidspartnere og etterforskere

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

Etterforskere

  • Studieleder: Janos Szederjesi, MD, PhD Assoc Prof, Department of Anesthesiology and Intensive Care, George Emil Palade University of Medicine, Pharmacy, Science and Technology of Târgu Mureș
  • Hovedetterforsker: Matild Keresztes, Department of Anesthesiology and Intensive Care, George Emil Palade University of Medicine, Pharmacy, Science and Technology of Târgu Mureș

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 (Faktiske)

1. mars 2024

Primær fullføring (Antatt)

31. juli 2026

Studiet fullført (Antatt)

31. desember 2027

Datoer for studieregistrering

Først innsendt

17. mai 2026

Først innsendt som oppfylte QC-kriteriene

17. mai 2026

Først lagt ut (Faktiske)

22. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

22. mai 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

17. mai 2026

Sist bekreftet

1. oktober 2025

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • 7633/18.04.2024 (Annen identifikator: Clinical Emergency County Hospital Targu Mures)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-deling Støtteinformasjonstype

  • STUDY_PROTOCOL
  • SEVJE

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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