Transversus Abdominis Plane (TAP) Block for Cesarean Section

Hyperalgesia, Secondary Clinical Trial

— CLOTAP  

Official title:

Transversus Abdominis Plane (TAP) Block for Cesarean Section

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01015807
• Other study ID #: 36707
• Status: Completed
• Phase: N/A
• First received: November 16, 2009
• Last updated: September 21, 2017
• Start date: November 2009
• Est. completion date: August 2012

Study information

• Verified date: September 2017
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether a transversus abdominis plane (TAP) block with Clonidine added to the injectate (Clo-TAP) performed approximately 2hrs after the cesarean section (CS) will decrease the amount of postoperative hyperalgesia and ultimately reduce post-CS chronic pain.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: August 2012
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Hyperalgesia
• Hyperalgesia, Secondary

Intervention

Drug:
• Bupivacaine Placebo
2 x 20mL 0.9% NaCl
• Clonidine Placebo
2 x 1mL 0.9% NaCl
• Bupivacaine
2 x 20mL 0.375% Bupivacaine = 150 mg Bupivacaine
• Clonidine
2 x 1ml Clonidine = 150 µg Clonidine

Locations

Country	Name	City	State
Brazil	Hospital e Maternidade Santa Joana	São Paulo
United States	University of Washington	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
University of Washington

Countries where clinical trial is conducted

United States,  Brazil, 

References & Publications (24)

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. — View Citation

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. — View Citation

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. Epub 2004 Oct 29. — View Citation

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. Review. — View Citation

Gabriel JS, Gordin V. Alpha 2 agonists in regional anesthesia and analgesia. Curr Opin Anaesthesiol. 2001 Dec;14(6):751-3. — View Citation

Kehlet H, Jensen TS, Woolf CJ. Persistent postsurgical pain: risk factors and prevention. Lancet. 2006 May 13;367(9522):1618-25. Review. — View Citation

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. — View Citation

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. — View Citation

Lavand'homme P. Perioperative pain. Curr Opin Anaesthesiol. 2006 Oct;19(5):556-61. Review. — View Citation

Lavand'homme P. Postcesarean analgesia: effective strategies and association with chronic pain. Curr Opin Anaesthesiol. 2006 Jun;19(3):244-8. Review. — View Citation

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. — View Citation

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. — View Citation

Marhofer P, Greher M, Kapral S. Ultrasound guidance in regional anaesthesia. Br J Anaesth. 2005 Jan;94(1):7-17. Epub 2004 Jul 26. Review. — View Citation

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. Review. — View Citation

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. — View Citation

McDonnell JG, Laffey JG. Transversus abdominis plane block. Anesth Analg. 2007 Sep;105(3):883. — View Citation

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. — View Citation

Mendez R, Eisenach JC, Kashtan K. Epidural clonidine analgesia after cesarean section. Anesthesiology. 1990 Nov;73(5):848-52. — View Citation

Nikolajsen L, Sørensen HC, Jensen TS, Kehlet H. Chronic pain following Caesarean section. Acta Anaesthesiol Scand. 2004 Jan;48(1):111-6. — View Citation

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:S104-8. Epub 2007 Jun 20. — View Citation

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. — View Citation

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. Epub 2007 May 30. — View Citation

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. — View Citation

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):22-8. Epub 2008 Jan 8. — View Citation

* Note: There are 24 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Wound Hyperalgesia Index (WHA) Assessed 48 Hrs After Block Placement in the Different Groups	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.	48hrs after CS