Post-operative Pain Clinical Trial
Official title:
Effects of Calot's Triangle Block for Postoperative Analgesia in Patients Undergoing Laparoscopic Cholecystectomy: a Prospective, Randomized, Double-blind, Controlled, Clinical Trial
Chronic pain after laparoscopic cholecystectomy (LC) is a common complication with an incidence ranging between 3-56%. In many cases, however, the cause chronic pain after LC remains unknown and visceral hyperalgesia and central sensitization have been suggested to be part of the pathophysiology. So the purpose of this study is to determine whether Calot's Triangle Block (CTB) combined with patient controlled intravenous analgesia (PCIA) is superior to PCIA in reducing the incidence of chronic pain after LC.
Status | Not yet recruiting |
Enrollment | 140 |
Est. completion date | November 2015 |
Est. primary completion date | August 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - men or woman over 18 the years and younger than 65 years old who will receive selective laparoscopic cholecystectomy. Exclusion Criteria: - age below 18 years or over 65 years - American Society of Anesthesiologists grade III or greater - Diabetes - chronic pain of any kind other than gallbladder disease - allergic to local anesthetics - cognitive impairment or communication problems - peptic ulcer - received opioids?NSAID or tranquilizers (treatment for over 1 wk before the cholecystectomy) - history of alcohol or drug abuse - the operation was converted to an open procedure - gangrenous cholecystitis - common bile duct exploration or insertion of a T-drain - other invasive procedures - severe hepatic or renal impairment - post-operative severe complications(e.g. pyogenic infection) |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
China | China,Chongqing The First Affiliated Hospital of Chongqing Medical University | Chongqing | Chongqing |
Lead Sponsor | Collaborator |
---|---|
First Affiliated Hospital of Chongqing Medical University |
China,
Bisgaard T, Klarskov B, Rosenberg J, Kehlet H. Characteristics and prediction of early pain after laparoscopic cholecystectomy. Pain. 2001 Feb 15;90(3):261-9. — View Citation
Bisgaard T, Rosenberg J, Kehlet H. From acute to chronic pain after laparoscopic cholecystectomy: a prospective follow-up analysis. Scand J Gastroenterol. 2005 Nov;40(11):1358-64. — View Citation
Blichfeldt-Eckhardt MR, Ording H, Andersen C, Licht PB, Toft P. Early visceral pain predicts chronic pain after laparoscopic cholecystectomy. Pain. 2014 Nov;155(11):2400-7. doi: 10.1016/j.pain.2014.09.019. Epub 2014 Sep 22. — View Citation
Desautels SG, Slivka A, Hutson WR, Chun A, Mitrani C, DiLorenzo C, Wald A. Postcholecystectomy pain syndrome: pathophysiology of abdominal pain in sphincter of Oddi type III. Gastroenterology. 1999 Apr;116(4):900-5. — View Citation
Donatsky AM, Bjerrum F, Gögenur I. Intraperitoneal instillation of saline and local anesthesia for prevention of shoulder pain after laparoscopic cholecystectomy: a systematic review. Surg Endosc. 2013 Jul;27(7):2283-92. doi: 10.1007/s00464-012-2760-z. Epub 2013 Jan 26. Review. — View Citation
Gurusamy KS, Nagendran M, Guerrini GP, Toon CD, Zinnuroglu M, Davidson BR. Intraperitoneal local anaesthetic instillation versus no intraperitoneal local anaesthetic instillation for laparoscopic cholecystectomy. Cochrane Database Syst Rev. 2014 Mar 13;3:CD007337. doi: 10.1002/14651858.CD007337.pub3. Review. — View Citation
Hickey OT, Burke SM, Hafeez P, Mudrakouski AL, Hayes ID, Shorten GD. Severity of acute pain after breast surgery is associated with the likelihood of subsequently developing persistent pain. Clin J Pain. 2010 Sep;26(7):556-60. doi: 10.1097/AJP.0b013e3181dee988. — View Citation
Ingelmo PM, Bucciero M, Somaini M, Sahillioglu E, Garbagnati A, Charton A, Rossini V, Sacchi V, Scardilli M, Lometti A, Joshi GP, Fumagalli R, Diemunsch P. Intraperitoneal nebulization of ropivacaine for pain control after laparoscopic cholecystectomy: a double-blind, randomized, placebo-controlled trial. Br J Anaesth. 2013 May;110(5):800-6. doi: 10.1093/bja/aes495. Epub 2013 Jan 4. — View Citation
Joris J, Thiry E, Paris P, Weerts J, Lamy M. Pain after laparoscopic cholecystectomy: characteristics and effect of intraperitoneal bupivacaine. Anesth Analg. 1995 Aug;81(2):379-84. — View Citation
Katz J, Jackson M, Kavanagh BP, Sandler AN. Acute pain after thoracic surgery predicts long-term post-thoracotomy pain. Clin J Pain. 1996 Mar;12(1):50-5. — View Citation
Kellow JE. Sphincter of Oddi dysfunction type III: another manifestation of visceral hyperalgesia? Gastroenterology. 1999 Apr;116(4):996-1000. — View Citation
Kurucsai G, Joó I, Fejes R, Székely A, Székely I, Tihanyi Z, Altorjay A, Funch-Jensen P, Várkonyi T, Madácsy L. Somatosensory hypersensitivity in the referred pain area in patients with chronic biliary pain and a sphincter of Oddi dysfunction: new aspects of an almost forgotten pathogenetic mechanism. Am J Gastroenterol. 2008 Nov;103(11):2717-25. doi: 10.1111/j.1572-0241.2008.02068.x. Epub 2008 Aug 5. — View Citation
Lamberts MP, Lugtenberg M, Rovers MM, Roukema AJ, Drenth JP, Westert GP, van Laarhoven CJ. Persistent and de novo symptoms after cholecystectomy: a systematic review of cholecystectomy effectiveness. Surg Endosc. 2013 Mar;27(3):709-18. doi: 10.1007/s00464-012-2516-9. Epub 2012 Oct 6. Review. — View Citation
Macrae WA. Chronic pain after surgery. Br J Anaesth. 2001 Jul;87(1):88-98. Review. — View Citation
Perkins FM, Kehlet H. Chronic pain as an outcome of surgery. A review of predictive factors. Anesthesiology. 2000 Oct;93(4):1123-33. Review. — View Citation
Shaffer E. Acalculous biliary pain: new concepts for an old entity. Dig Liver Dis. 2003 Jul;35 Suppl 3:S20-5. Review. — View Citation
SHAFIROFF BG, HINTON JW. Surgical anatomy of the choledochal nerves. Arch Surg. 1950 May;60(5):944-952. — View Citation
Womack NA, Crider RL. The Persistence of Symptoms Following Cholecystectomy. Ann Surg. 1947 Jul;126(1):31-55. — View Citation
Woolf CJ. Central sensitization: implications for the diagnosis and treatment of pain. Pain. 2011 Mar;152(3 Suppl):S2-15. doi: 10.1016/j.pain.2010.09.030. Epub 2010 Oct 18. Review. — View Citation
* Note: There are 19 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Chronic post-surgical pain | Chronic post-surgical pain intensity will be measured as more than 3 months by numerical rating scale (NRS) for pain | 3 months post-operatively | No |
Secondary | Acute pain post-operatively | Pain intensity will be measured by visual analogue scale(VAS) | 2h,4h,6h,12h,24h, 48h post-operatively | No |
Secondary | Analgesic Rescue | The dosages of opioid or non-opioid analgesic rescue medications | from 2h to 48h post-operatively | No |
Secondary | Adverse events associated with post-operative analgesia | incomplete analgesia; nausea and vomiting; respiratory depression; over-sedation | from 2h to 48h post-operatively | Yes |
Secondary | moderate-severe pain | Pain intensity will be measured by numerical rating scale (NRS) | 3,6months postoperatively | No |
Secondary | chronic post-surgical pain | chronic post-surgical pain intensity will be measured by numerical rating scale (NRS) for pain | 6months postoperatively | No |
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