Abdominal Wall Nerve Blockade: A Comparison With Local Port Site Injection as Well as Between the Use of Ultrasound and Laparoscopy to Guide Placement
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Pain control after abdominal surgery in children is often a complex, multifaceted problem that requires a multimodal approach to treatment. Infiltration of wounds with long-acting local anesthetic, either into the surgical field or through locoregional nerve blockade, has been known to decrease narcotic requirements. Nerve blocks of the abdominal wall can occur through several modalities, among them the transverse abdominis plane block and the rectus sheath block. The transversus abdominis plane (TAP) block places local anesthetic in a plane between the internal oblique and transversus abdominis muscles, directly blocking innervation of spinal nerves T9-L3, the ilioinguinal, iliohypogastric and lateral cutaneous branches of L1-3, reducing pain sensation to the anterior abdominal wall. The rectus sheath block places local anesthetic between the internal oblique and transversus abdominis at the level of the terminal branches of intercostal nerves 9-11.
The investigators will perform a prospective randomized study to compare the effectiveness of laparoscopic-guided abdominal wall nerve blocks with local wound site infiltration and with ultrasounded guided abdominal wall blocks.
The goal of this study is to determine whether patients who receive a nerve block have significantly less pain compared to patients who receive local infiltration of anesthetic. Secondly, the investigators believe that laparoscopic-guided abdominal wall nerve blocks should be as effective as abdominal wall blocks performed under ultrasound-guidance, and may in fact allow for more consistent infiltration of local anesthetic to desired nerve bundles. Thirdly, the investigators believe that laparoscopic-guided abdominal wall nerve blocks are significantly less time intensive than ultrasound-guided abdominal wall nerve blocks, allowing a cost savings and decreased time under general anesthesia.
Studietype
Fase
- Ikke aktuelt
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Patients 5 - 17 years old.
- Patients undergoing laparoscopic procedures
- Patients that weigh greater than or equal to 34 kg and less than 100 kg.
Exclusion Criteria:
- Patients who underwent open surgical procedures will be excluded from this study.
- Patients that weigh less than 34kg.
- Patients that weigh more than 100 kg.
- Perforated appendicitis.
- Bowel obstruction
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Helsetjenesteforskning
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Ingen inngripen: Local port site injection
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Ingen inngripen: Ultrasound-guided nerve blocks
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Eksperimentell: Laparoscopic guided nerve blocks
These patients will receive the same volume of local anesthetic as those in the ultrasound-guided arm, but the delivery of the local anesthetic will be guided by laparoscopy.
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It is common to use ultrasound to define the correct plane for abdominal wall nerve blocks, however, the utilization of laparoscopy to identify this plane is a new intervention that is previously undescribed in children.
Ropivacaine is a local anesthetic used to prevent pain during and after procedures.
In this study, ropivacaine will be injected either directly at the port sites, or for a regional abdominal wall nerve block, either under ultrasound or laparoscopic guidance.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
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Minutes under anesthesia
Tidsramme: 2 years
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2 years
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Pain scores
Tidsramme: 2 years
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2 years
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Narcotic usage
Tidsramme: 2 years
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2 years
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Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
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
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- PRO16050059
Plan for individuelle deltakerdata (IPD)
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