Effects of Calot's Triangle Block for Postoperative Analgesia in Patients Undergoing Laparoscopic Cholecystectomy: a Prospective, Randomized, Double-blind, Controlled, Clinical Trial
NCT ID: NCT02300480
Last Updated: 2014-11-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
140 participants
INTERVENTIONAL
2014-12-31
2015-11-30
Brief Summary
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Detailed Description
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This study was approved by the institutional review board of the First Affiliated Hospital of Chongqing Medical University. The protocol design is in accordance with Consolidated Standards of Reporting Trials (CONSORT) statement. All potentially eligible participants will be asked to give written informed consent before they are enrolled in this study. This study is a prospective, randomized, double-blind, controlled clinical trial guided by the standard of good clinical practice (GCP), and eligible participants are divided into two groups: group CTB and group PCIA, and primary assess the outcomes of the incidence of chronic pain after LC and the intensity of acute pain after LC.
Participants in group CTB will receive a single injection of ropivacaine in calot's triangle before surgical dissection combined with PCIA post-operatively.
Participants in group PCIA will receive a single injection in calot's triangle with normal saline before surgical dissection and PCIA post-operatively.
The primary outcome of this study is the incidence of chronic pain after LC.
The secondary outcomes of this study are acute post-operative pain, moderate-severe pain, rescue medication and adverse events associated with the post-operative analgesia.
This study will be conducted under the supervision of an independent auditor. Every week, the auditor checked the data of the participants the day after the surgery was conducted. Assessment of pain intensity and prognostic outcomes must be confirmed by the auditor in sample population. When there is disagreement between surgeon and anesthesiologists in evaluating the prognosis of patients, the auditor must solve this disagreement by discussion with evaluators. Data will be double-entered by two statisticians with limitation of access and locked during statistical analysis.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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CTB group
Participants in this group will receive a single injection for calot's triangle block combined with PCIA post-operatively. CTB will be conducted by bile duct needle and 1.0% 10 ml ropivacaine will be injection in calot's triangle when before surgical dissection.Participants in this group will also receive PCIA after surgery,the regimens of PCIA are included tramadol 800 mg, flurbiprofenaxetil 100 mg with normal saline added up to a volume of 80 ml in total.
CTB group
CTB: A single injection of 1.0% 10ml ropivacaine by bile duct needle in calot's triangle when before surgical dissection.After surgery,participants in this group will also receive PCIA.
PCIA group
Participants in this group will receive PCIA post-operatively (tramadol 800 mg and flurbiprofen axetil 100mg with normal saline added up to a volume of 80ml in total ) .The PCIA pump was set up with a 5 ml loading dose, a 2 ml bolus dose, a 15 min lockout interval and background infusion at a rate of 1 ml/h.
PCIA group
The formula of the PCIA included tramadol 800 mg, flurbiprofen axetil 100mg with saline added up to a volume of 80 ml in total. The PCIA pump was set up with a 5 ml loading dose, a 2 ml bolus dose, a 15 min lockout interval and background infusion at a rate of 1 ml/h.
Interventions
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CTB group
CTB: A single injection of 1.0% 10ml ropivacaine by bile duct needle in calot's triangle when before surgical dissection.After surgery,participants in this group will also receive PCIA.
PCIA group
The formula of the PCIA included tramadol 800 mg, flurbiprofen axetil 100mg with saline added up to a volume of 80 ml in total. The PCIA pump was set up with a 5 ml loading dose, a 2 ml bolus dose, a 15 min lockout interval and background infusion at a rate of 1 ml/h.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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)
18 Years
65 Years
ALL
No
Sponsors
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First Affiliated Hospital of Chongqing Medical University
OTHER
Responsible Party
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Min Su
The Department of Anesthesiology and Pain Medicine
Principal Investigators
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Su Min, MD
Role: PRINCIPAL_INVESTIGATOR
First Affiliated Hospital of Chongqing Medical University
Locations
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China,Chongqing The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Su Min, MD
Role: primary
Dong Zhang, Master
Role: backup
References
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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.
Bisgaard T, Klarskov B, Rosenberg J, Kehlet H. Characteristics and prediction of early pain after laparoscopic cholecystectomy. Pain. 2001 Feb 15;90(3):261-269. doi: 10.1016/S0304-3959(00)00406-1.
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.
Macrae WA. Chronic pain after surgery. Br J Anaesth. 2001 Jul;87(1):88-98. doi: 10.1093/bja/87.1.88. No abstract available.
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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. doi: 10.1080/00365520510023675.
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.
Donatsky AM, Bjerrum F, Gogenur 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.
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.
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. doi: 10.1016/s0016-5085(99)70073-9.
Woolf CJ. Central sensitization: implications for the diagnosis and treatment of pain. Pain. 2011 Mar;152(3 Suppl):S2-S15. doi: 10.1016/j.pain.2010.09.030. Epub 2010 Oct 18.
Shaffer E. Acalculous biliary pain: new concepts for an old entity. Dig Liver Dis. 2003 Jul;35 Suppl 3:S20-5. doi: 10.1016/s1590-8658(03)00089-6.
SHAFIROFF BG, HINTON JW. Surgical anatomy of the choledochal nerves. Arch Surg (1920). 1950 May;60(5):944-952. doi: 10.1001/archsurg.1950.01250010967009. No abstract available.
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Kurucsai G, Joo I, Fejes R, Szekely A, Szekely I, Tihanyi Z, Altorjay A, Funch-Jensen P, Varkonyi T, Madacsy 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.
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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. doi: 10.1097/00002508-199603000-00009.
Other Identifiers
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CYYYMZ-005
Identifier Type: -
Identifier Source: org_study_id