- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT01407666
Comparison Between Epidural and Bilateral Paravertebral Blocks in Liver Resection
2 december 2014 uppdaterad av: University of Pittsburgh
Prospective Randomized Comparative Study Between Epidural and Bilateral Paravertebral Blocks for Perioperative Pain Management in Patients Undergoing Open Liver Resection
This prospective, randomized study is intended to assess the efficacy and safety of bilateral continuous paravertebral blocks compared to continuous epidural block for open liver resection.
Hypotheses: Bilateral paravertebral blocks are: 1) equally effective in controlling the perioperative pain; and 2) safe, with less frequent complications following open liver resection when compared to continuous epidural block.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
Background: A number of studies evaluating unilateral continuous paravertebral block demonstrate equal or superior analgesia when compared to epidural analgesia for postoperative pain control (1-7).
At the same time, these studies show a decreased incidence of side effects and complications, including: hypotension, pulmonary complications, urinary retention, nausea and vomiting and failed blocks.
Several studies also indicate that bilateral paravertebral blocks provide adequate postoperative analgesia (8-14).
However, no study has been performed to date that shows a direct comparison between epidural and bilateral paravertebral blocks in patients undergoing open liver resection.Objectives:
This prospective, randomized study is intended to assess the efficacy and safety of bilateral continuous paravertebral blocks compared to continuous epidural block for open liver resection.
Hypotheses: Bilateral paravertebral blocks are: 1) equally effective in controlling the perioperative pain; and 2) safe, with less frequent complications following open liver resection when compared to continuous epidural block.Methods: A hundred adult patients undergoing elective open liver resection will be randomized to receive a continuous epidural block or continuous bilateral paravertebral blocks for perioperative analgesia.
The primary outcome will be the degree of pain control measured by visual analog scale at 24 hours post surgery (at rest and while the patient is performing maximum incentive spirometry).
The secondary outcomes will include: 1) Assessment of pain (at rest, with cough, and with ambulation) using the verbal numerical pain scale will be performed postoperatively every 8 hours by floor nursing staff until discharge.
During the night the patient will not be awakened for pain assessment.
2) Intravenous opioid requirement: In addition to pain score, postoperative intravenous opioid requirements [hydromorphone (mg)] will also be recorded daily; Frequency of side effects and complications; and other functional status (volume of maximum incentive spirometry, time to extubation, total time for initial ambulation, the length of the hospital stay, time to return of bowel function, readiness for discharge from the hospital, and length of hospital stay).
At one month post surgery, health-related quality of life, mortality, and any morbidities will be assessed.
Each variable will be compared between the paravertebral group and the epidural group to examine the hypotheses above.
Clinical Implications: Bilateral continuous paravertebral blocks could be an equally effective and safe alternative to a continuous epidural block for perioperative pain management in patients who undergo open liver resection.
Studietyp
Interventionell
Inskrivning (Faktisk)
100
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
Pennsylvania
-
Pittsburgh, Pennsylvania, Förenta staterna, 15213
- University of Pittsburgh School of Medicine
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
Inclusion Criteria:
- American Society of Anesthesiologists physical status (ASAPS) I to III patients aged over 18 years and scheduled to undergo elective open liver resection at UPMC Presbyterian/Montefiore Hospital will be screened for enrollment in the study. One hundred (100) patients will be enrolled in this study with equal numbers (n = 50) in each arm of the trial. In order to avoid skewed sex difference between the two groups, the sex will be allocated.
Exclusion Criteria:
- non elective surgery,
- ASAPS IV or greater,
- age younger than 18 years,
- any contraindication to the placement of an epidural catheter or bilateral paravertebral catheters
- chronic pain conditions
- preoperative opioid use
- coagulation abnormalities or patients who are expected to be on therapeutic anticoagulants postoperatively
- allergy to any of the drugs/agents used our study protocol
- preoperative chronic renal dysfunction, who requires renal replacement therapy or serum creatinine greater than 1.4 mg/dL
- altered mental status (not oriented to place, person, or time),
- any comorbid conditions that, in the judgment of the consulting surgeon or anesthesiologist, would proscribe the patient from any aspect of the study, -
- inability to provide adequate informed consent
- refusal to participate in the study.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Bilateral paravertebral blocks
Bilateral continuous paravertebral blocks for open liver resection
|
use bilateral thoracic paravertebral blocks for pain control
Andra namn:
|
|
Inget ingripande: epidural block
received thoracic epidural block for open liver resection
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Pain immediately after maximum incentive spirometry
Tidsram: 24 hours postoperatively
|
Pain will be assessed using an 11-point verbal numerical pain scale (VAS) with 0 indicating no pain and 10 indicating the worst pain imaginable;(21) pain will be determined 24 hours postoperatively immediately after maximum incentive spirometry.
|
24 hours postoperatively
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
date of the removal of the catheter
Tidsram: up to one week after the surgery
|
date of the removal of the catheter with any requirement of blood transfusion because of coagulation
|
up to one week after the surgery
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: Tetsuro Sakai, MD, PhD, University of Pittsburgh
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 augusti 2010
Primärt slutförande (Faktisk)
1 augusti 2014
Avslutad studie (Faktisk)
1 november 2014
Studieregistreringsdatum
Först inskickad
17 februari 2011
Först inskickad som uppfyllde QC-kriterierna
29 juli 2011
Första postat (Uppskatta)
2 augusti 2011
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
3 december 2014
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
2 december 2014
Senast verifierad
1 december 2014
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- MOD09070393-01 / PRO09070393
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .