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Efficacy of Adding Dexmedetomidine as an Adjuvant to Bupivacaine in TAP Block and Caudal Block

12. oktober 2021 oppdatert av: Ain Shams University

Effect of Dexmedetomidine as an Adjuvant to Bupivacaine in Ultrasound Guided Transversus Abdominis Plane Block Versus Caudal Block for Post-operative Analgesia in Children Undergoing Congenital Inguinal Hernia Repair

This study compares the efficacy of Dexmedetomidine as an adjuvant to Bupivacaine in Ultrasound Guided Transversus Abdominis Plane Block versus Caudal Block for post-operative analgesia in children undergoing congenital inguinal hernia repair especially to provide prolonged post-operative analgesia and decrease opioid consumption.

Studieoversikt

Status

Rekruttering

Intervensjon / Behandling

Detaljert beskrivelse

Inguinal hernia is the most common lower abdominal surgery of childhood. It results from a small sac that comes through the inguinal ring that is normally open during fetal life and closes around the time of birth. For reasons we don't understand, it does not close in some infants. This sac then makes a pathway for abdominal organs to come through the inguinal ring into the groin . In boys, the organ is usually a loop of bowel and in girls; it may be bowel or an ovary. In boys and girls, the hernia first appears as a bulge in the groin. It usually "pops out" when the child cries or strains. If only fluid comes through the inguinal ring into the sac, the problem is called a hydrocele. It is treated via a low transverse incision to repair the defect.

Postoperatively, patients experience somatosensory pain from the incision site and visceral irritation and discomfort .

The impact of painful experience on the young nervous system is so significant that long-term effects can occur, including a lowered pain tolerance for months after a pain-producing event however, the benefits of adequate analgesia include attenuation of the surgical stress response, decreased perioperative morbidity and improved outcome in certain types of surgery. Also effective pain control facilitates rehabilitation and accelerates recovery from surgery .

Regional anesthesia and analgesia techniques are commonly used to facilitate pain control during pediatric surgical practice, decrease parenteral opioids requirements and improve the quality of post-operative pain control and patient-parent satisfaction.

Caudal epidural anesthesia is considered the gold standard regional technique for pain management after pediatric pelvic and lower abdominal procedures because it blocks both somatic and visceral pain. The caudal block has a low complication rate (0.7 per 1000) , provides 4 to 6 hours of analgesia, and results in improved patient pain scores than in patients having general anesthesia alone .

An increased understanding of abdominal wall anatomy has led to the introduction of the transversus abdominis plane block (TAPB) for managing pain after lower abdominal surgery .TAPB provides reliable unilateral sensory block in the T10-L1 distribution with a single injection, and resulted in a significant decrease in postoperative pain scores and opioid requirements after major abdominal surgeries . Similar outcomes have been observed in pediatric studies, and analgesia after TAPB in pediatric patients is thought to last 10 to 15 hours .

The technique of TAP block has been found to be a safe and effective tool in a variety of general, gynaecological, and urological surgery, and it is suggested as part of the multimodal anaesthetic approach to enhance recovery after lower abdominal surgeries .

However, the duration of analgesia provided by these strategies is limited by the short duration of action of the local anesthetic .

Various adjuvants to local anesthetics have been investigated to improve the quality of block and duration of analgesia, including Dexmedetomidine, fentanyl, morphine, ketamine, midazolam, and magnesium.

Each of these adjuvants has side effects specific to the type and dose of adjuvant used. For instance, behavioral changes have been noted with the use of caudal ketamine, opioids are associated with risk of respiratory depression, and the neurotoxicity of midazolam is still controversial. Therefore, an ideal adjuvant that provides maximal analgesia with minimal side effects for these blocks is still a matter of contention.

Dexmedetomidine (DEX) is a highly selective α2-adrenoceptor agonist, possesses sedative, analgesic, anxiolytic, and anti-inflammatory properties . When administered in combination with local anesthetics in the epidural space, it has been shown to reduce postoperative analgesic requirements and have a significantly

Studietype

Intervensjonell

Registrering (Forventet)

50

Fase

  • Fase 2
  • Fase 1

Kontakter og plasseringer

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

Studiekontakt

Studer Kontakt Backup

Studiesteder

      • Cairo, Egypt, 02
        • Rekruttering
        • Ainshams hospitals
        • 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

2 år til 12 år (Barn)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • age 2-12 years
  • Elective congenital inguinal hernia repair operation under general anaesthesia.
  • Physical Status: ASA I and II Patients after taking written and informed consent from the parents or care giver.

Exclusion Criteria:

  • Refusal of procedure or participation in the study by parents.
  • Physical status: ASA III or above.
  • Children undergoing bilateral lower abdominal surgeries.
  • Infection at site of injection.
  • Congenital anomaly of the spine.
  • History of developmental delay, neurological disease, skeletal deformities.
  • History or evidence of coagulopathy.
  • Allergies to drugs used (Bupivacaine 0.5%)( dexmedetomidine/prcedex)

Studieplan

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

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Forebygging
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Dobbelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: TAP block
patients will receive general anesthesia followed by Tap block at the end of the operation.

Patients will be monitored using standard monitoring (heart rate, non-invasive blood pressure, ECG and pulse oximetery) After the child is adequately anesthetized, intra-venous access with appropriate size cannula will be obtained Appropriate size LMA (2 and 2.5) will be inserted and patients will be allowed to breathe spontaneously.

patients will receive 0.25% Bupivacaine (0.3ml/Kg) with 1 μg/kg dexmedetomidine After general anaesthesia

Andre navn:
  • Bupivakain
Eksperimentell: Caudal block
patients will receive general anesthesia followed by caudal block at the beginning of the operation.

Patients will be monitored using standard monitoring (heart rate, non-invasive blood pressure, ECG and pulse oximetery) After the child is adequately anesthetized, intra-venous access with appropriate size cannula will be obtained Appropriate size LMA (2 and 2.5) will be inserted and patients will be allowed to breathe spontaneously.

patients will receive 0.25% Bupivacaine (0.3ml/Kg) with 1 μg/kg dexmedetomidine After general anaesthesia

Andre navn:
  • Bupivakain

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
When Dexmedetomidine is administered in combination with local anesthetics in the epidural space, it has been shown to reduce postoperative analgesic requirements and have a significantly analgesic effect"
Tidsramme: Within 24 hours post operative
The primary outcome measures were the time to first analgesia (in minutes from the time of caudal (or) TAP block injection to first registration of modified VAS scale ≥3 at any point of time will receive paracetamol 10mg/kg orally
Within 24 hours post operative

Samarbeidspartnere og etterforskere

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

Etterforskere

  • Studiestol: Bahaa Eldeen Ewis, Professor, Professor of Anesthesia, Intensive Care and pain management

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Hjelpsomme linker

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)

22. september 2020

Primær fullføring (Forventet)

25. oktober 2021

Studiet fullført (Forventet)

30. oktober 2021

Datoer for studieregistrering

Først innsendt

23. mai 2021

Først innsendt som oppfylte QC-kriteriene

8. juni 2021

Først lagt ut (Faktiske)

15. juni 2021

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

14. oktober 2021

Siste oppdatering sendt inn som oppfylte QC-kriteriene

12. oktober 2021

Sist bekreftet

1. juni 2021

Mer informasjon

Begreper knyttet til denne studien

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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