Study to Test the Efficacy of Periarticular Levo Bupivicaine Injection Following Primary Hip Arthroplasty
16. april 2010 oppdatert av: Orthopaedic Research and Innovation Foundation, Ireland
A Double Blind Randomized Control Trial on the Efficacy of Periarticular Levo Bupivicaine Injection Following Primary Hip Arthroplasty
The hypothesis of this study is that isolated use of local periarticular levobupivicaine injection during primary hip arthroplasty would improve post-operative pain control.
Patients were randomised in the operating room to receive either a periarticular infiltration, or a placebo consisting of Saline.
Morphine and analgesic consumption was recorded for each patient, while the modified McGill pain scale was used to determine the adequacy of analgesia and the benefit of the peri-articular infiltration.
91 patients were recruited, with 45 patients in the treatment group and 46 controls.
The results were assessed after one year, once all the information from both treatment groups was collected.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
The efficacy of periarticular injections during total knee arthroplasty is well established but there is little published data on their effect in primary hip arthroplasty.
We hypothesized that isolated use of local periarticular levobupivicaine injection during primary hip arthroplasty would improve post-operative pain control.
A double blinded, randomised, placebo-controlled trial on patients undergoing primary hip arthroplasty was performed.
Patients were randomised in theatre to receive either a periarticular infiltration of 150mg levobupivicaine in 60mls of 0.9% Saline, or a placebo consisting of 60mls 0.9% Saline.
Morphine and analgesic consumption was recorded for each patient, while the modified McGill pain scale was used to determine the adequacy of analgesia and the benefit of the peri-articular infiltration.
91 patients were recruited, with 45 patients in the treatment group and 46 controls.
The results were assessed after one year, once all the information from both treatment groups was collected.
Studietype
Intervensjonell
Registrering (Faktiske)
91
Fase
- Fase 4
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Finglas
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Dublin, Finglas, Irland, Dublin 11
- Cappagh National Orthopaedic Hospital
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Santry
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Dublin, Santry, Irland, Dublin 9
- Orthopaedic Research and Innovation Foundation
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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
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Consecutive patients undergoing primary hip arthroplasty for osteoarthritis only were included in this study after giving informed consent.
Exclusion Criteria:
- Patients with cognitive impairment, neurological disorders, advanced liver or renal impairment, known ischemic heart disease, a previous diagnosis of a pain syndrome or any post-operative surgical or medical complications were excluded.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Aktiv komparator: Levobupivacaine
Levobupivacaine is indicated for local anaesthesia including infiltration, nerve block, ophthalmic, epidural and intrathecal anaesthesia in adults; and infiltration analgesia in children
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The treatment group received 150mg of levobupivicaine in 60mls of 0.9% saline.
This was injected intra-operatively through the medial and anterior capsular spaces in the region of the obturator and femoral nerves and also around the short rotators and gluteus maximus in the region of the inferior and superior gluteal nerves.
The timing of this was after insertion of the acetabular component.
10mls was then infiltrated around the tensor fascia lata and subcutaneously prior to closing the wound.
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Placebo komparator: Saline
Saline (also saline solution) is a general term referring to a sterile solution of sodium chloride (NaCl, more commonly known as salt) in water but is only sterile when it is placed intravenously, otherwise, a saline solution is a salt water solution.
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The placebo group received 60mls of 0.9% saline injected intra-operatively through the medial and anterior capsular spaces in the region of the obturator and femoral nerves and also around the short rotators and gluteus maximus in the region of the inferior and superior gluteal nerves.
The timing of this was after insertion of the acetabular component.
10mls was then infiltrated around the tensor fascia lata and subcutaneously prior to closing the wound.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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To determine a significant difference (p>0.05) in morphine consumption between the two treatment groups post-operatively.
Tidsramme: 1 year
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The modified McGill pain scale was administered to determine the adequacy of analgesia and the benefit of the peri-articular infiltration.
In addition, morphine and analgesic consumption was recorded for each patient.
The results were assessed after one year, once all the information from both treatment groups was collected.
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1 year
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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To analyse the length of stay for between both treatment groups
Tidsramme: Average 6 days (based on precise day of discharge)
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Average 6 days (based on precise day of discharge)
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Etterforskere
- Hovedetterforsker: Kevin J Mulhall, Orthopaedic Research and Innovation Foundation, Ireland
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.
Generelle publikasjoner
- Andersen KV, Pfeiffer-Jensen M, Haraldsted V, Soballe K. Reduced hospital stay and narcotic consumption, and improved mobilization with local and intraarticular infiltration after hip arthroplasty: a randomized clinical trial of an intraarticular technique versus epidural infusion in 80 patients. Acta Orthop. 2007 Apr;78(2):180-6. doi: 10.1080/17453670710013654.
- Parvataneni HK, Shah VP, Howard H, Cole N, Ranawat AS, Ranawat CS. Controlling pain after total hip and knee arthroplasty using a multimodal protocol with local periarticular injections: a prospective randomized study. J Arthroplasty. 2007 Sep;22(6 Suppl 2):33-8. doi: 10.1016/j.arth.2007.03.034. Epub 2007 Jul 26.
- Toftdahl K, Nikolajsen L, Haraldsted V, Madsen F, Tonnesen EK, Soballe K. Comparison of peri- and intraarticular analgesia with femoral nerve block after total knee arthroplasty: a randomized clinical trial. Acta Orthop. 2007 Apr;78(2):172-9. doi: 10.1080/17453670710013645.
- Maheshwari AV, Blum YC, Shekhar L, Ranawat AS, Ranawat CS. Multimodal pain management after total hip and knee arthroplasty at the Ranawat Orthopaedic Center. Clin Orthop Relat Res. 2009 Jun;467(6):1418-23. doi: 10.1007/s11999-009-0728-7. Epub 2009 Feb 13.
- Busch CA, Shore BJ, Bhandari R, Ganapathy S, MacDonald SJ, Bourne RB, Rorabeck CH, McCalden RW. Efficacy of periarticular multimodal drug injection in total knee arthroplasty. A randomized trial. J Bone Joint Surg Am. 2006 May;88(5):959-63. doi: 10.2106/JBJS.E.00344.
- Essving P, Axelsson K, Kjellberg J, Wallgren O, Gupta A, Lundin A. Reduced hospital stay, morphine consumption, and pain intensity with local infiltration analgesia after unicompartmental knee arthroplasty. Acta Orthop. 2009 Apr;80(2):213-9. doi: 10.3109/17453670902930008.
- Fu P, Wu Y, Wu H, Li X, Qian Q, Zhu Y. Efficacy of intra-articular cocktail analgesic injection in total knee arthroplasty - a randomized controlled trial. Knee. 2009 Aug;16(4):280-4. doi: 10.1016/j.knee.2008.12.012. Epub 2009 Mar 18.
- Lombardi AV Jr, Berend KR, Mallory TH, Dodds KL, Adams JB. Soft tissue and intra-articular injection of bupivacaine, epinephrine, and morphine has a beneficial effect after total knee arthroplasty. Clin Orthop Relat Res. 2004 Nov;(428):125-30. doi: 10.1097/01.blo.0000147701.24029.cc.
- Nechleba J, Rogers V, Cortina G, Cooney T. Continuous intra-articular infusion of bupivacaine for postoperative pain following total knee arthroplasty. J Knee Surg. 2005 Jul;18(3):197-202. doi: 10.1055/s-0030-1248181.
- Andersen LJ, Poulsen T, Krogh B, Nielsen T. Postoperative analgesia in total hip arthroplasty: a randomized double-blinded, placebo-controlled study on peroperative and postoperative ropivacaine, ketorolac, and adrenaline wound infiltration. Acta Orthop. 2007 Apr;78(2):187-92. doi: 10.1080/17453670710013663.
- Chen DW, Hsieh PH, Huang KC, Hu CC, Chang YH, Lee MS. Continuous intra-articular infusion of bupivacaine for post-operative pain relief after total hip arthroplasty: a randomized, placebo-controlled, double-blind study. Eur J Pain. 2010 May;14(5):529-34. doi: 10.1016/j.ejpain.2009.08.008. Epub 2009 Sep 24.
- Fischer HB, Simanski CJ. A procedure-specific systematic review and consensus recommendations for analgesia after total hip replacement. Anaesthesia. 2005 Dec;60(12):1189-202. doi: 10.1111/j.1365-2044.2005.04382.x.
- Foster RH, Markham A. Levobupivacaine: a review of its pharmacology and use as a local anaesthetic. Drugs. 2000 Mar;59(3):551-79. doi: 10.2165/00003495-200059030-00013.
- Gristwood RW, Greaves JL. Levobupivacaine: a new safer long acting local anaesthetic agent. Expert Opin Investig Drugs. 1999 Jun;8(6):861-76. doi: 10.1517/13543784.8.6.861.
- Gwilym SE, Pollard TC, Carr AJ. Understanding pain in osteoarthritis. J Bone Joint Surg Br. 2008 Mar;90(3):280-7. doi: 10.1302/0301-620X.90B3.20167.
- Gallagher EJ, Bijur PE, Latimer C, Silver W. Reliability and validity of a visual analog scale for acute abdominal pain in the ED. Am J Emerg Med. 2002 Jul;20(4):287-90. doi: 10.1053/ajem.2002.33778.
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
1. september 2008
Primær fullføring (Faktiske)
1. september 2009
Studiet fullført (Faktiske)
1. september 2009
Datoer for studieregistrering
Først innsendt
12. april 2010
Først innsendt som oppfylte QC-kriteriene
16. april 2010
Først lagt ut (Anslag)
19. april 2010
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
19. april 2010
Siste oppdatering sendt inn som oppfylte QC-kriteriene
16. april 2010
Sist bekreftet
1. juli 2008
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- KM-042008-014
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