Denna sida har översatts automatiskt och översättningens korrekthet kan inte garanteras. Vänligen se engelsk version för en källtext.

Transversus Abdominis Plane Block in Iliac Crest harvest-is it Beneficial?

20 december 2016 uppdaterad av: Dr. Vigil Peter, Jubilee Mission Medical College and Research Institute

Transversus Abdominis Plane Block Supplementation During Iliac Crest Bone Graft Harvest - Its Influence on Postoperative Parameters

The purpose of this study is to determine whether a supplemental Transversus Abdominis Plane block administered intraoperatively improves the postoperative parameters in patients undergoing Alveolar bone grafting with iliac crest harvest. It also aims to find out if there is a decrease in the incidence of chronic pain or numbness at the harvest site.

Studieöversikt

Detaljerad beskrivning

This study is a prospective, randomised, parallel group, single - centre trial evaluating the postoperative parameters in patients receiving supplemental Transversus Abdominis Plane block for anterior iliac crest harvest. It was conducted in 143 patients undergoing Alveolar bone grafting with iliac crest bone graft.

Methodology:

Informed consent and approval of local ethics and research committee in Jubilee Mission Medical College and Research Institute, Thrissur, India was obtained prior to initiation of the study. A pilot study was done to determine the efficacy of the additional TAP block. The results showed that the intervention improved patient analgesia and reduced the requirement for rescue analgesics. A minimum sample size of 65 patients was calculated for each group to obtain a power of 80% and confidence interval of 95%. 143 patients aged between 7 and 22 years posted for Alveolar bone grafting with anterior iliac crest harvest were assessed in the study. Only those undergoing Alveolar bone grafting as a part of the reconstructive procedure for cleft lip and palate were considered for the study. The patients who had difficulty in mentation and communication,bleeding disorders, hepatic problems, infection of the abdominal wall, renal dysfunction as well as allergy to the local anaesthetic were excluded from the study. Patients undergoing revision surgeries were also excluded from the study. All the candidates were randomly alloted to either of the two groups, using a computer - generated number.

All the patients were premedicated with Midazolam 0.15mg kg-1 and Glycopyrolate 0.01mg kg-1 Anaesthesia was induced with Propofol 2 mg kg -1 and Fentanyl 2 mcg kg-1 .Vecuronium 0.1 mg kg-1 was given to facilitate orotracheal intubation with a cuffed tube.Anaesthesia was maintained with oxygen, nitrous oxide and sevoflurane. Prior to incision, all the patients were given wound infiltration with 0.75 ml kg-1 of 0.2% Ropivacaine at the graft harvest site. Those in group A received an additional ultrasound guided Transversus Abdominis Plane block with a similar volume and concentration of Ropivacaine.

At the end of the surgical procedure, the patients were extubated awake, after giving I / V Neostigmine 0.05 mg kg-1. Just prior to extubation, I/V Tramadol 0.5 mg kg-1 was given for the pain in the postoperative period. In the recovery room, the pain and emergence delirium were assessed by an independent observer every ten minutes during the first postoperative hour.These were evaluated using the FLACC Behavioural Pain Assessment Scale and WATCHA Scale respectively. They were subsequently shifted to the postoperative ward.

The next time point of assessment was 24 hours post - surgery, when the patient's pain and ambulatory status were evaluated. The pain was ranked using the five - point verbal ranking score. It was ranked as no pain, light pain, moderate pain, severe pain and intolerable pain, with a score of 0,1,2,3 and 4 respectively. The total number of rescue analgesics demanded by the patient on the first postoperative day was noted.Ambulatory status was graded using one - day Cumulated Ambulatory Score.

The patients were followed up and questioned at six weeks and twelve weeks post operatively for the presence of chronic pain, numbness or wound healing problems at the harvest site.

Studietyp

Interventionell

Inskrivning (Faktisk)

143

Fas

  • Inte tillämpbar

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

4 år till 22 år (Barn, Vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

Inclusion Criteria:

  • Must undergo alveolar bone grafting as a part of the reconstructive procedure for cleft lip and palate

Exclusion Criteria:

  • Revision procedure
  • History of difficulty in mentation and communication
  • Bleeding disorders, hepatic problems or renal dysfunction
  • Allergy to local anaesthetic
  • Presence of infection of anterior abdominal wall

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: Parallellt uppdrag
  • Maskning: Dubbel

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Local Infiltration with TAP block
Ultrasound guided Transversus Abdominis Plane block is administered intraoperatively using 0.2% Ropivacaine.
Local infiltration of the iliac crest harvest site along with TAP block using 0.2 % Ropivacaine is done
Experimentell: Local Infiltration only
Local Infiltration with 0.2% Ropivacaine.
Only local infiltration with 0.2% Ropivacaine of the iliac crest harvest site is done.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Mean pain scores
Tidsram: First hour after extubation
Mean pain scores were assessed using the FLACC Behavioural Pain Assessment Scale,
First hour after extubation
Emergence delirium
Tidsram: First hour after extubation
Emergence delirium was assessed using WATCHA Scale during the first hour after extubation
First hour after extubation
Pain scores
Tidsram: 24 hours after surgery
Pain scores using the five - point verbal ranking score 24 hours after surgery
24 hours after surgery
Ambulatory status
Tidsram: 24 hours after surgery
Ambulatory status was assessed using one - day Cumulated Ambulatory Score 24 hours after surgery
24 hours after surgery

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Infection and delayed healing at the graft harvest site
Tidsram: 6 weeks after surgery
All patients were interviewed for the presence of infection or delayed healing at the graft harvest site 6 weeks after surgery.
6 weeks after surgery
Chronic pain, numbness or discomfort at graft harvest site
Tidsram: 12 weeks after the surgery
All the patients were reviewed 12 weeks after surgery for the presence of chronic pain, numbness or discomfort at iliac crest harvest
12 weeks after the surgery

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Utredare

  • Huvudutredare: Vigil Peter, MD, Jubilee Mission Medical College and Research Institute

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

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 april 2016

Primärt slutförande (Faktisk)

1 augusti 2016

Avslutad studie (Faktisk)

1 november 2016

Studieregistreringsdatum

Först inskickad

15 december 2016

Först inskickad som uppfyllde QC-kriterierna

16 december 2016

Första postat (Uppskatta)

19 december 2016

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

22 december 2016

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

20 december 2016

Senast verifierad

1 december 2016

Mer information

Termer relaterade till denna studie

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

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 .

Prenumerera