- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01015807
Transversus Abdominis Plane (TAP) Block for Cesarean Section (CLOTAP)
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Acute severe pain after cesarean section (CS) occurs more often than is thought and 10-15% of the women having a cesarean section develop chronic pain (Kehlet et al. 2006). With over 1.3 million cesarean deliveries per year in the US, this is bound to create a significant health problem. One way to address this health burden is to refine techniques that may help control the pain women experience after CS and ultimately reduce the potential to develop chronic pain.
The purpose of this randomized, double-blinded study is to evaluate the ability of an established anesthetic technique called the transversus abdominis plane (TAP) block to reduce the amount of hyperalgesia women develop around their incision after CS. Measuring the amount of punctuate mechanical hyperalgesia is used as a tool to assess postoperative central sensitization (Lavand'homme et al. 2005), which contributes to postoperative acute pain. Since postoperative acute pain has been shown to be predictive of developing postoperative chronic pain (Eisenach et al. 2008; Yarnitsky et al. 2008), an effective TAP block could help diminish the incidence of chronic pain after CS. In addition, blood samples will be collected for future genetic analysis and we will test preoperatively for mechanical temporal summation (mTS) to evaluate CNS (central nervous system) sensitization and nociceptive system hyperexcitability and see if this correlates with the amount of hyperalgesia women develop around their incision after surgery.
The primary aim of this study is to evaluate the benefits of two different solutions injected by TAP block technique on postoperative peri-incisional hyperalgesia.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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São Paulo, Brasil, 04103-080
- Hospital e Maternidade Santa Joana
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Washington
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Seattle, Washington, Forente stater, 98195
- University of Washington
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- non-laboring women who will benefit from and have clinically consented to a scheduled or non-scheduled cesarean delivery under spinal anesthesia
- English speaking (UW Site) or Portuguese speaking (Brazil site)
- aged between 18 and 45 years
- BMI < 40
- ASA physical status class I or II
Exclusion Criteria:
- laboring women undergoing a non-scheduled cesarean delivery
- non-English speaking (UW Site) or non-Portuguese speaking (Brazil site)
- previous spinal surgery
- contraindications for neuraxial anesthesia
- allergy to local anesthetic, ultrasound conduction gel, or Clonidine
- history of chronic pain
- inability to receive intraoperative Toradol
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Placebo komparator: Placebo
Sterile Saline used for TAP block = Bupivacaine Placebo + Clonidine Placebo
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2 x 20mL 0.9% NaCl
Andre navn:
2 x 1mL 0.9% NaCl
Andre navn:
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Aktiv komparator: TAP (Bupi)
2x20mL 0.375% Bupivacaine + 2x1mL of 0.9% NaCl = 150mg Bupivacaine + Clonidine Placebo
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2 x 1mL 0.9% NaCl
Andre navn:
2 x 20mL 0.375% Bupivacaine = 150 mg Bupivacaine
Andre navn:
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Aktiv komparator: Clo-TAP (Bupi + Clon)
2x20mL 0.375% Bupivacaine + 2x1mL Clonidine = 150mg Bupivacaine + 150µg Clonidine
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2 x 20mL 0.375% Bupivacaine = 150 mg Bupivacaine
Andre navn:
2 x 1ml Clonidine = 150 µg Clonidine
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Wound Hyperalgesia Index (WHA) Assessed 48 Hrs After Block Placement in the Different Groups
Tidsramme: 48hrs after CS
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Determine which of three different TAP formulations (Placebo, TAP, Clo-TAP) has the most beneficial effect on the postoperative area of hyperalgesia 48hrs after the start of the cesarean section.
The smaller the area of WHA, assessed in cm2, the better the outcome.
Area sizes may range from 0 to any size.
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48hrs after CS
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Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Laurent Bollag, MD, University of Washington
- Studiestol: Ruth Landau, MD, University of Washington
Publikasjoner og nyttige lenker
Generelle publikasjoner
- McDonnell JG, Curley G, Carney J, Benton A, Costello J, Maharaj CH, Laffey JG. The analgesic efficacy of transversus abdominis plane block after cesarean delivery: a randomized controlled trial. Anesth Analg. 2008 Jan;106(1):186-91, table of contents. doi: 10.1213/01.ane.0000290294.64090.f3.
- Kehlet H, Jensen TS, Woolf CJ. Persistent postsurgical pain: risk factors and prevention. Lancet. 2006 May 13;367(9522):1618-25. doi: 10.1016/S0140-6736(06)68700-X.
- McDonnell JG, O'Donnell BD, Farrell T, Gough N, Tuite D, Power C, Laffey JG. Transversus abdominis plane block: a cadaveric and radiological evaluation. Reg Anesth Pain Med. 2007 Sep-Oct;32(5):399-404. doi: 10.1016/j.rapm.2007.03.011.
- McCartney CJ, Duggan E, Apatu E. Should we add clonidine to local anesthetic for peripheral nerve blockade? A qualitative systematic review of the literature. Reg Anesth Pain Med. 2007 Jul-Aug;32(4):330-8. doi: 10.1016/j.rapm.2007.02.010.
- Nikolajsen L, Sorensen HC, Jensen TS, Kehlet H. Chronic pain following Caesarean section. Acta Anaesthesiol Scand. 2004 Jan;48(1):111-6. doi: 10.1111/j.1399-6576.2004.00271.x.
- Weissman-Fogel I, Granovsky Y, Crispel Y, Ben-Nun A, Best LA, Yarnitsky D, Granot M. Enhanced presurgical pain temporal summation response predicts post-thoracotomy pain intensity during the acute postoperative phase. J Pain. 2009 Jun;10(6):628-36. doi: 10.1016/j.jpain.2008.12.009. Epub 2009 Apr 23.
- Yarnitsky D, Crispel Y, Eisenberg E, Granovsky Y, Ben-Nun A, Sprecher E, Best LA, Granot M. Prediction of chronic post-operative pain: pre-operative DNIC testing identifies patients at risk. Pain. 2008 Aug 15;138(1):22-28. doi: 10.1016/j.pain.2007.10.033. Epub 2008 Jan 8.
- Lavand'homme P, De Kock M, Waterloos H. Intraoperative epidural analgesia combined with ketamine provides effective preventive analgesia in patients undergoing major digestive surgery. Anesthesiology. 2005 Oct;103(4):813-20. doi: 10.1097/00000542-200510000-00020.
- Lavand'homme P. Postcesarean analgesia: effective strategies and association with chronic pain. Curr Opin Anaesthesiol. 2006 Jun;19(3):244-8. doi: 10.1097/01.aco.0000192815.22989.61.
- Mendez R, Eisenach JC, Kashtan K. Epidural clonidine analgesia after cesarean section. Anesthesiology. 1990 Nov;73(5):848-52. doi: 10.1097/00000542-199011000-00009.
- Eisenach JC, De Kock M, Klimscha W. alpha(2)-adrenergic agonists for regional anesthesia. A clinical review of clonidine (1984-1995). Anesthesiology. 1996 Sep;85(3):655-74. doi: 10.1097/00000542-199609000-00026. No abstract available.
- Duma A, Urbanek B, Sitzwohl C, Kreiger A, Zimpfer M, Kapral S. Clonidine as an adjuvant to local anaesthetic axillary brachial plexus block: a randomized, controlled study. Br J Anaesth. 2005 Jan;94(1):112-6. doi: 10.1093/bja/aei009. Epub 2004 Oct 29.
- Pan PH, Coghill R, Houle TT, Seid MH, Lindel WM, Parker RL, Washburn SA, Harris L, Eisenach JC. Multifactorial preoperative predictors for postcesarean section pain and analgesic requirement. Anesthesiology. 2006 Mar;104(3):417-25. doi: 10.1097/00000542-200603000-00007.
- Lavand'homme PM, Roelants F, Waterloos H, De Kock MF. Postoperative analgesic effects of continuous wound infiltration with diclofenac after elective cesarean delivery. Anesthesiology. 2007 Jun;106(6):1220-5. doi: 10.1097/01.anes.0000267606.17387.1d.
- Lavand'homme P. Perioperative pain. Curr Opin Anaesthesiol. 2006 Oct;19(5):556-61. doi: 10.1097/01.aco.0000245284.53152.1f.
- Marhofer P, Greher M, Kapral S. Ultrasound guidance in regional anaesthesia. Br J Anaesth. 2005 Jan;94(1):7-17. doi: 10.1093/bja/aei002. Epub 2004 Jul 26.
- Buchanan ML, Easterling TR, Carr DB, Shen DD, Risler LJ, Nelson WL, Mattison DR, Hebert MF. Clonidine pharmacokinetics in pregnancy. Drug Metab Dispos. 2009 Apr;37(4):702-5. doi: 10.1124/dmd.108.024984. Epub 2008 Dec 30.
- Carvalho B, Angst MS, Fuller AJ, Lin E, Mathusamy AD, Riley ET. Experimental heat pain for detecting pregnancy-induced analgesia in humans. Anesth Analg. 2006 Nov;103(5):1283-7. doi: 10.1213/01.ane.0000239224.48719.28.
- Gabriel JS, Gordin V. Alpha 2 agonists in regional anesthesia and analgesia. Curr Opin Anaesthesiol. 2001 Dec;14(6):751-3. doi: 10.1097/00001503-200112000-00024.
- Landau R, Schiffer E, Morales M, Savoldelli G, Kern C. The dose-sparing effect of clonidine added to ropivacaine for labor epidural analgesia. Anesth Analg. 2002 Sep;95(3):728-34, table of contents. doi: 10.1097/00000539-200209000-00036.
- Lavand'homme PM, Roelants F, Waterloos H, Collet V, De Kock MF. An evaluation of the postoperative antihyperalgesic and analgesic effects of intrathecal clonidine administered during elective cesarean delivery. Anesth Analg. 2008 Sep;107(3):948-55. doi: 10.1213/ane.0b013e31817f1595.
- McDonnell JG, Laffey JG. Transversus abdominis plane block. Anesth Analg. 2007 Sep;105(3):883. doi: 10.1213/01.ane.0000268542.45107.79. No abstract available.
- Ohel I, Walfisch A, Shitenberg D, Sheiner E, Hallak M. A rise in pain threshold during labor: a prospective clinical trial. Pain. 2007 Nov;132 Suppl 1:S104-S108. doi: 10.1016/j.pain.2007.05.007. Epub 2007 Jun 20.
- Parker RK, Connelly NR, Lucas T, Serban S, Pristas R, Berman E, Gibson C. Epidural clonidine added to a bupivacaine infusion increases analgesic duration in labor without adverse maternal or fetal effects. J Anesth. 2007;21(2):142-7. doi: 10.1007/s00540-006-0476-8. Epub 2007 May 30.
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
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
Ytterligere relevante MeSH-vilkår
- Sykdommer i nervesystemet
- Nevrologiske manifestasjoner
- Sensasjonsforstyrrelser
- Somatosensoriske lidelser
- Hyperalgesi
- Fysiologiske effekter av legemidler
- Adrenerge midler
- Nevrotransmittere agenter
- Molekylære mekanismer for farmakologisk virkning
- Antihypertensive midler
- Sentralnervesystemdepressiva
- Autonome agenter
- Agenter fra det perifere nervesystemet
- Analgetika
- Sensoriske systemagenter
- Bedøvelsesmidler
- Adrenerge alfa-2-reseptoragonister
- Adrenerge alfa-agonister
- Adrenerge agonister
- Anestesimidler, lokal
- Sympatolytika
- Bupivakain
- Klonidin
Andre studie-ID-numre
- 36707
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
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