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

NCT02300480 | Unknown Phase 4

• 1 other identifier: CYYYMZ-005
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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.

Conditions

Post-operative Pain; Gallstone Disease

Keywords

pain; calot's triangle; local block; analgesia; patient controlled intravenous analgesia

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

• Acute pain post-operatively

  2h,4h,6h,12h,24h, 48h post-operatively

• Analgesic Rescue

  from 2h to 48h post-operatively

• Adverse events associated with post-operative analgesia

  from 2h to 48h post-operatively

• moderate-severe pain

  3,6months postoperatively

• chronic post-surgical pain

  6months postoperatively

Study Arms (2)

CTB group

EXPERIMENTAL

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

PCIA group

ACTIVE COMPARATOR

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

Interventions

CTB group PROCEDURE

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.

CTB group

PCIA group PROCEDURE

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.

PCIA group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• men or woman over 18 the years and younger than 65 years old who will receive selective laparoscopic cholecystectomy.

You may not qualify if:

• 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)

Sponsors & Collaborators

• First Affiliated Hospital of Chongqing Medical University: lead

Study Sites (1)

China,Chongqing The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 400016, China

Location

Related Publications (19)

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MeSH Terms

Conditions

Pain, Postoperative; Cholelithiasis; Pain; Agnosia

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms; Biliary Tract Diseases; Digestive System Diseases; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Study Officials

• Su Min, MD

  First Affiliated Hospital of Chongqing Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dong Zhang, Master

CONTACT

+86-23-89011061; zdcqmua420@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: The Department of Anesthesiology and Pain Medicine

Study Record Dates

• First Submitted: November 19, 2014
• First Posted: November 25, 2014
• Study Start: December 1, 2014
• Primary Completion: August 1, 2015
• Study Completion: November 1, 2015
• Last Updated: November 26, 2014

Record last verified: 2014-11

Locations

CN (1)