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Effects of Calot's Triangle Block for Postoperative Analgesia in Patients Undergoing Laparoscopic Cholecystectomy: a Prospective, Randomized, Double-blind, Controlled, Clinical Trial

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ClinicalTrials.gov Identifier: NCT02300480
Recruitment Status : Unknown
Verified November 2014 by Min Su, First Affiliated Hospital of Chongqing Medical University.
Recruitment status was:  Not yet recruiting
First Posted : November 25, 2014
Last Update Posted : November 26, 2014
Sponsor:
Information provided by (Responsible Party):
Min Su, First Affiliated Hospital of Chongqing Medical University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Post-operative Pain Gallstone Disease Procedure: CTB group Procedure: PCIA group Phase 4

Detailed Description:

Laparoscopic cholecystectomy (LC) is currently regarded as the gold standard treatment for symptomatic gallstone disease. Compared with open cholecystectomy, LC benefits include less postoperative pain, reduced analgesic consumption, and earlier discharge. However, besides the advantages mentioned above, there are exist complexity and diversity of the acute pain after LC, which consists of a somatic, a visceral and a referred pain component. Meanwhile, our team also found many LC patients experience visceral pain after surgery. According to epidemic research show that chronic pain after LC is a common complication with an incidence ranging between 3-56%. Several reports have indicated that early postoperative pain has been shown to be a significant risk factor of chronic pain. In many cases, however, the cause chronic pain after LC remains unknown and visceral hyperalgesia and central sensitizationhave been suggested to be part of the pathophysiology. To reduce the incidence of chronic pain after LC, so we conduct the randomized controlled trial to investigate whether calot's triangle block combined with PCIA is superior to PCIA in reducing the incidence of chronic pain after LC.

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Calot's Triangle Block for Postoperative Analgesia in Patients Undergoing Laparoscopic Cholecystectomy: a Prospective, Randomized, Double-blind, Controlled, Clinical Trial
Study Start Date : December 2014
Estimated Primary Completion Date : August 2015
Estimated Study Completion Date : November 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
Procedure: 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.

Active Comparator: 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.
Procedure: 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.




Primary Outcome Measures :
  1. Chronic post-surgical pain [ Time Frame: 3 months post-operatively ]
    Chronic post-surgical pain intensity will be measured as more than 3 months by numerical rating scale (NRS) for pain


Secondary Outcome Measures :
  1. Acute pain post-operatively [ Time Frame: 2h,4h,6h,12h,24h, 48h post-operatively ]
    Pain intensity will be measured by visual analogue scale(VAS)

  2. Analgesic Rescue [ Time Frame: from 2h to 48h post-operatively ]
    The dosages of opioid or non-opioid analgesic rescue medications

  3. Adverse events associated with post-operative analgesia [ Time Frame: from 2h to 48h post-operatively ]
    incomplete analgesia; nausea and vomiting; respiratory depression; over-sedation

  4. moderate-severe pain [ Time Frame: 3,6months postoperatively ]
    Pain intensity will be measured by numerical rating scale (NRS)

  5. chronic post-surgical pain [ Time Frame: 6months postoperatively ]
    chronic post-surgical pain intensity will be measured by numerical rating scale (NRS) for pain



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02300480


Contacts
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Contact: Dong Zhang, Master +86-23-89011061 zdcqmua420@163.com

Locations
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China, Chongqing
China,Chongqing The First Affiliated Hospital of Chongqing Medical University Not yet recruiting
Chongqing, Chongqing, China, 400016
Contact: Su Min, MD    +86-23-89011068    ms89011068@163.com   
Contact: Dong Zhang, Master    +86-23-89011061    zdcqmua420@163.com   
Sponsors and Collaborators
First Affiliated Hospital of Chongqing Medical University
Investigators
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Principal Investigator: Su Min, MD First Affiliated Hospital of Chongqing Medical University

Publications:

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Responsible Party: Min Su, The Department of Anesthesiology and Pain Medicine, First Affiliated Hospital of Chongqing Medical University
ClinicalTrials.gov Identifier: NCT02300480     History of Changes
Other Study ID Numbers: CYYYMZ-005
First Posted: November 25, 2014    Key Record Dates
Last Update Posted: November 26, 2014
Last Verified: November 2014

Keywords provided by Min Su, First Affiliated Hospital of Chongqing Medical University:
pain
calot's triangle
local block
analgesia
patient controlled intravenous analgesia

Additional relevant MeSH terms:
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Gallstones
Cholelithiasis
Cholecystolithiasis
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Biliary Tract Diseases
Digestive System Diseases
Gallbladder Diseases
Calculi
Pathological Conditions, Anatomical
Flurbiprofen axetil
Tramadol
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Antirheumatic Agents