Double blind randomized comparative study of transdermal fentanyl patch for post operative pain relief in major abdominal surgery as a component of multimodal analgesic therapy

Authors

  • Kalyani Surya Dhanalakshmi Sangineni Department of Anaesthesiology, Bhaskar Medical College, Moinabad, Hyderabad, Telangana, India
  • Anuradha Deolalkar Department of Anaesthesiology, Bhaskar Medical College, Moinabad, Hyderabad, Telangana, India
  • S. C. Parakh Department of Anaesthesiology, Bhaskar Medical College, Moinabad, Hyderabad, Telangana, India
  • D. Dharma Rajuloo Department of Anaesthesiology, Bhaskar Medical College, Moinabad, Hyderabad, Telangana, India

DOI:

https://doi.org/10.18203/2319-2003.ijbcp20160077

Keywords:

Postoperative pain, Fentanyl patch, Multimodal analgesia

Abstract

Background: There are various methods of alleviating post-operative pain, multimodal analgesia is the recommended practice. Fentanyl patch can also be used in the management of acute postoperative pain. We have done a study to compare the efficacy of fentanyl patch to a placebo patch as a part of multimodal analgesic strategy.

Methods: Forty four patients were randomized into two groups. Groups were named as FP (Fentanyl patch) and P (Placebo). The Patch was placed 10-12 hours before surgery and patient was monitored for 72 hours postoperatively for pain by NRS (Numeric Rating Scale). All the patients received regular Paracetamol and Diclofenac Sodium. Tramadol was given as rescue analgesia if the NRS scale was more than 5. Data was analysed using Windows stat version 9.2 from Indostat services.

Results: There was statistically significant difference in the consumption of Tramadol in patients with FP group (19.44 mg) as compared to P group (72.22mg) over 72 hours. The Numerical Rating scale was also much lower in the FP group at 8, 16, 24, 32, 40, 48, 56, 64 and 72 hours. Maximum difference in the pain score being at 24 hours for the FP group. No difference in the Sedation, Pruritus, Respiratory depression, Nausea and vomiting scores in the two groups.

Conclusions: Transdermal Fentanyl Patch of 25 µg/hr when applied 10-12 hours before surgery provides effective postoperative pain relief after major abdominal surgery as a part of multimodal analgesia.

References

Vadivelu N, Mitra S, Narayan D. Recent advances in postoperative pain management. Yale J Biol Med. 2010;83(1):11-25.

Canet J, Mazo V. Postoperative pulmonary complications. Minerva Anestesiologica. 2010;76(2):138-4.

Kehlet H, Dahl JB. The value of multimodal or balanced analgesia in the postoperative pain treatment. Anesth Analg. 1993;77:1048-56.

Kehlet H, Dahl JB. Anaesthesia, surgery and challenges in postoperative recovery. Lancet. 2003;362:1921-8.

Margetts L, Sawyer R. Continuing Education in Anaesthesia, Critical Care & Pain. 2007;7(5).

McCaffery M, Ferrell B. Nurses ‘knowledge of pain assessment and management: how much progress have we made? J Pain Symptom Manage. 1997;14(3):175-88.

Ong CK, Seymour RA, Lirk P, Merry AF. Combining paracetamol (acetaminophen) with nonsteroidal antiinflammatory drugs: a qualitative systematic review of analgesic efficacy for acute postoperative pain. Anesth Analg. 2010;110(4):1170-9.

Sathyan G, Guo C, Sivakumar K. Evaluation of the bioequivalence of two transdermal fentanyl systems following single and repeat applications. Curr Med Res Opin. 2005;21(12):1961-8.

Davis MP. Management of cancer pain:focus on new opioid analgesic formulations. Am J Cancer. 2006;5(3):171-82.

Beattie WS, Buckley DN, Forrest JB. Epidural morphine reduces risk of postoperative myocardial ischaemia in patients with cardiac risk factors. Can J Anasth. 1993:40(6):532-44.

Basali A, Mascha EJ, Kalfas I, Schubert A. Relation between perioperative hypertension and intracranial hemorrhage after craniotomy. Anaesthesiology 2000:93(1):48-54.

Perkins FM, Kehlet H. Chronic pain as an outcome of surgery. A review of predictive factors. Anesthesiology. 2000;93(4):1123-33.

Culp WC Jr, Beyer EA. Preoperative inspiratory muscle training and postoperative complications. JAMA. 2007:297(7)697-8.

Agnelli G, Bolis G, Capussoti L, Tonelli F. A clinical outcome based prospective study on venous thromboembolism after cancer surgery: The @RISTOS project. Ann Surg. 2006;243(1):89-95.

Camann W, Abouleish A, Eisenach J, Hood D. Intrathecal sufentanil and epidural bupivacaine for labor analgesia: dose-response of individual agents and in combination. Reg Anesth Pain Med. 1998;23(5):457-62.

Elia N, Lysakowski C, Tramèr MR. Does multimodal analgesia with acetaminophen, nonsteroidal anti-inflammatory drugs, or selective cyclooxygenase-2 inhibitors and patient-controlled analgesia morphine offer advantages over morphine alone? Anesthesiology. 2005;103(6):1296-304.

Carli F, Mayo N, Klubien K, Schricker T. Epidural analgesia enhances functional exercise capacity and health-related quality of life after colonic surgery: results of a randomized trial. Anesthesiology. 2002;97(3):540-9.

Viscusi ER, Reynolds L, Chung F, Atkinson LE. Patient-controlled transdermal fentanyl hydrochloride vs intravenous morphine pump for postoperative pain: a randomized controlled trial. JAMA. 2004;17:1333-41.

Birnbach DJ, Johnson MD, Arcario T, Datta S. Effect of diluent volume on analgesia produced by epidural fentanyl. Anesth Analg. 1989;68(6):808-10.

Patel D, Chaudhary SA, Parmar B, Bhura N. Transdermal delivery System:A Review. The Pharma Journal.com. 2012;1(4).

Bajaj S, Whiteman A, Brandner B. Transdermal drug delivery in pain management. BJA. 2011;11(2):39-43.

Fen-Touch Company Insert,Sparsha Pharma International Pvt. Limited.www.sparsha.com. Accessed July 2, 2014.

Gottschalk A, Smith DS. New concepts in Acute Pain therapy: Preemptive analgesia. Am Fam Physician. 2001;63(10):1979-84.

Woolf CJ, Chong MS. Preemptive Analgesia-treating postoperative pain by preventing the establishment of central sensitization. Anaes Analge. 1993;77(2):362-7.

Richmond CE, Bromley LM, Woolf CJ. Preoperative morphine preempts postoperative pain. Lancet. 1993;342(8863):73-5.

Joshi GP, Ogunnaike BO. Consequences of inadequate postoperative pain relief and chronic persistent postoperative pain. Anaesiol Clin North Am. 2005;23(1):21-36.

White PF. Multimodal Analgesia;its role in preventing postoperative pain. Curr Opin Investig Drugs. 2008;9(1):76-82.

Kehlet H, Wilmore DW. Multimodal strategies to improve surgical outcome. Am J Surg. 2002;183(6):630-41.

Rowbotham DJ, Wyld R, Peacock JE, Duthie DJ, Nimmo WS. Transdermal fentanyl for the relief of pain after upper abdominal surgery. Br J Anesth. 1989;63:56-9.

Sevarino FB, Paige D, Sinatra RS. Postoperative analgesia with parenteral opioids: does continuous delivery utilizing a transdermal opioid preparation affect analgesic efficacy or patient safety? J Clin Anesth. 1997;9(3):173-8.

Osipova NA, Petrova VV, Lastukhin AV, Kudriavtsev SB, Vashakmadze LA, Khomiakov VM. Prevention and treatment of postoperative pain syndrome in extensive thoracoabdominal oncological surgery. Anesteziol Reanimatol. 2010;(3):29-33.

Reeves MD, Ginifer CJ. Fatal intravenous misuse of Transdermal Fentanyl Patch. Medical Journal of Australia. 2002;177(10):552-3.

Edinboro LE, Poklis A, Trautman D. Fatal Fentanyl intoxication following excessive transdermal application. J Forensic Sci. 1997;42(4):741-3.

Lehman LJ, Desio JM, Radvany T, Bikhazi GB. Transdermal Fentanyl in postoperative pain. Reg Anaes. 1997:22(1):24-8.

Reinhart DJ, Goldberg ME, Roth JV, Dua R, Nevo I, Klein KW. Transdermal fentanyl system plus im ketorolac for the treatment of postoperative pain. Canadian Journal of Anaesthesia. Can J Anaesth. 1997;44(4):377-84.

Merivirta R, Äärimaa V, Aantaa R, Koivisto M, Leino K, Liukas A. Postoperative Fentanyl Patch versus subacromial Bupivacaine infusion in arthroscopic shoulder surgery. Arthroscopy. The Journal of Arthroscopic and related surgery. Arthroscopy. 2013;29(7):1129-34.

Sathitkarnmanee T, Tribuddharat S, Noiphitak K, Theerapongpakdee S, Pongjanyakul S. Transdermal fentanyl patch for postoperative analgesia in total knee arthroplasty: a randomized double-blind controlled trial. Journal of Pain Research. 2014;7:449-54.

WHO. WHO’s cancer pain ladder for adults. 2009. http://www.who.int/cancer/palliative/painladder/en. Accessed July 2, 2014.

Samy AA, Mostafa MG, Mostafa MAM. Efficacy and Safety of Transdermal Fentanyl Patches on Postoperative Pain Relief After Major Abdominal Surgery. J Am Sci. 2012;8(6):417-24.

Downloads

Published

2016-12-24

How to Cite

Sangineni, K. S. D., Deolalkar, A., Parakh, S. C., & Rajuloo, D. D. (2016). Double blind randomized comparative study of transdermal fentanyl patch for post operative pain relief in major abdominal surgery as a component of multimodal analgesic therapy. International Journal of Basic & Clinical Pharmacology, 5(1), 13–20. https://doi.org/10.18203/2319-2003.ijbcp20160077

Issue

Section

Original Research Articles