- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT02997124
Transversus Abdominis Plane Block in Iliac Crest harvest-is it Beneficial?
Transversus Abdominis Plane Block Supplementation During Iliac Crest Bone Graft Harvest - Its Influence on Postoperative Parameters
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Doppio
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 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
|
|
Sperimentale: Local Infiltration only
Local Infiltration with 0.2% Ropivacaine.
|
Only local infiltration with 0.2% Ropivacaine of the iliac crest harvest site is done.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Mean pain scores
Lasso di tempo: First hour after extubation
|
Mean pain scores were assessed using the FLACC Behavioural Pain Assessment Scale,
|
First hour after extubation
|
|
Emergence delirium
Lasso di tempo: First hour after extubation
|
Emergence delirium was assessed using WATCHA Scale during the first hour after extubation
|
First hour after extubation
|
|
Pain scores
Lasso di tempo: 24 hours after surgery
|
Pain scores using the five - point verbal ranking score 24 hours after surgery
|
24 hours after surgery
|
|
Ambulatory status
Lasso di tempo: 24 hours after surgery
|
Ambulatory status was assessed using one - day Cumulated Ambulatory Score 24 hours after surgery
|
24 hours after surgery
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Infection and delayed healing at the graft harvest site
Lasso di tempo: 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
Lasso di tempo: 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
|
Collaboratori e investigatori
Investigatori
- Investigatore principale: Vigil Peter, MD, Jubilee Mission Medical College and Research Institute
Pubblicazioni e link utili
Pubblicazioni generali
- McDonnell JG, O'Donnell B, Curley G, Heffernan A, Power C, Laffey JG. The analgesic efficacy of transversus abdominis plane block after abdominal surgery: a prospective randomized controlled trial. Anesth Analg. 2007 Jan;104(1):193-7. doi: 10.1213/01.ane.0000250223.49963.0f. Erratum In: Anesth Analg. 2007 May;104(5):1108.
- O'Donnell BD, McDonnell JG, McShane AJ. The transversus abdominis plane (TAP) block in open retropubic prostatectomy. Reg Anesth Pain Med. 2006 Jan-Feb;31(1):91. doi: 10.1016/j.rapm.2005.10.006. No abstract available. Erratum In: Reg Anesth Pain Med. 2006 May-Jun;31(3):286. McDonnell, John G [added]; McShane, Alan J [added].
- Kim DH, Rhim R, Li L, Martha J, Swaim BH, Banco RJ, Jenis LG, Tromanhauser SG. Prospective study of iliac crest bone graft harvest site pain and morbidity. Spine J. 2009 Nov;9(11):886-92. doi: 10.1016/j.spinee.2009.05.006. Epub 2009 Jun 18.
- Chiono J, Bernard N, Bringuier S, Biboulet P, Choquet O, Morau D, Capdevila X. The ultrasound-guided transversus abdominis plane block for anterior iliac crest bone graft postoperative pain relief: a prospective descriptive study. Reg Anesth Pain Med. 2010 Nov-Dec;35(6):520-4. doi: 10.1097/AAP.0b013e3181fa117a.
- Sandhu HS, Grewal HS, Parvataneni H. Bone grafting for spinal fusion. Orthop Clin North Am. 1999 Oct;30(4):685-98. doi: 10.1016/s0030-5898(05)70120-6.
- Heary RF, Schlenk RP, Sacchieri TA, Barone D, Brotea C. Persistent iliac crest donor site pain: independent outcome assessment. Neurosurgery. 2002 Mar;50(3):510-6; discussion 516-7. doi: 10.1097/00006123-200203000-00015.
- DeOrio JK, Farber DC. Morbidity associated with anterior iliac crest bone grafting in foot and ankle surgery. Foot Ankle Int. 2005 Feb;26(2):147-51. doi: 10.1177/107110070502600206.
- Silber JS, Anderson DG, Daffner SD, Brislin BT, Leland JM, Hilibrand AS, Vaccaro AR, Albert TJ. Donor site morbidity after anterior iliac crest bone harvest for single-level anterior cervical discectomy and fusion. Spine (Phila Pa 1976). 2003 Jan 15;28(2):134-9. doi: 10.1097/00007632-200301150-00008.
- Kessler P, Thorwarth M, Bloch-Birkholz A, Nkenke E, Neukam FW. Harvesting of bone from the iliac crest--comparison of the anterior and posterior sites. Br J Oral Maxillofac Surg. 2005 Feb;43(1):51-6. doi: 10.1016/j.bjoms.2004.08.026.
- Zijderveld SA, ten Bruggenkate CM, van Den Bergh JP, Schulten EA. Fractures of the iliac crest after split-thickness bone grafting for preprosthetic surgery: report of 3 cases and review of the literature. J Oral Maxillofac Surg. 2004 Jul;62(7):781-6. doi: 10.1016/j.joms.2003.12.018.
- Rawashdeh MA, Telfah H. Secondary alveolar bone grafting: the dilemma of donor site selection and morbidity. Br J Oral Maxillofac Surg. 2008 Dec;46(8):665-70. doi: 10.1016/j.bjoms.2008.07.184. Epub 2008 Aug 29.
- Kalk WW, Raghoebar GM, Jansma J, Boering G. Morbidity from iliac crest bone harvesting. J Oral Maxillofac Surg. 1996 Dec;54(12):1424-9; discussion 1430. doi: 10.1016/s0278-2391(96)90257-8.
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 07/16/IEC/JMMC&RI
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su Dolore, Postoperatorio
-
Cairo UniversityCompletatoSCOPO PAIN (VAS) a 24 ore dopo l'interventoEgitto
-
University of OklahomaThe Children's Hospital at OU Medical CenterCompletatoDolore addominale funzionale | Crisi falciforme | Pazienti seguiti dal Pain Team
-
King Abdulaziz UniversityReclutamentoDisturbi temporomandibolari (TMD) | Dolore dell'ATM | Arteterapia | TMJ - orale & amp; chirurgia maxillofaciale | Wilkes 1 e 2 | TMD Art Pain StudyArabia Saudita
Prove cliniche su local infiltration and TAP block
-
University of PadovaReclutamentoParto cesareo | Blocco di anestesia regionaleItalia
-
Uppsala UniversityReclutamentoGestione del dolore dopo l'intervento chirurgicoSvezia
-
Sahiwal medical college sahiwalCompletatoBradicardia | Analgesia postoperatoria | Anestesia con risparmio di oppioidi | Ipotensione, controllata | Procedura di inversione dello stomaPakistan
-
Erzurum Regional Training & Research HospitalReclutamentoGestione del dolore | TAP Blocca | Mtapa BlockTurchia (Türkiye)
-
University of BirminghamSconosciutoMalocclusione, Classe Angle IIRegno Unito
-
San Salvatore Hospital of L'AquilaCompletatoDolore postoperatorioItalia
-
Cairo UniversityReclutamentoAnestesia | Chirurgia colorettale laparoscopica | Blocco del Piano Trasverso dell'Addome Posteriore | Blocco del Piano del Multifido SacraleEgitto
-
Vittore Buzzi Children's HospitalReclutamentoDolore postoperatorioItalia
-
Singapore General HospitalSconosciutoIsterectomia addominale (& Wertheim)
-
Hvidovre University HospitalCompletatoDolore postoperatorio e consumo postoperatorio di morfina dopo isterectomia addominaleDanimarca