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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

Primary Purpose

Post-operative Pain, Gallstone Disease

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
CTB group
PCIA group
Sponsored by
First Affiliated Hospital of Chongqing Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post-operative Pain focused on measuring pain, calot's triangle, local block, analgesia, patient controlled intravenous analgesia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • China,Chongqing The First Affiliated Hospital of Chongqing Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

CTB group

PCIA group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Chronic post-surgical pain
Chronic post-surgical pain intensity will be measured as more than 3 months by numerical rating scale (NRS) for pain

Secondary Outcome Measures

Acute pain post-operatively
Pain intensity will be measured by visual analogue scale(VAS)
Analgesic Rescue
The dosages of opioid or non-opioid analgesic rescue medications
Adverse events associated with post-operative analgesia
incomplete analgesia; nausea and vomiting; respiratory depression; over-sedation
moderate-severe pain
Pain intensity will be measured by numerical rating scale (NRS)
chronic post-surgical pain
chronic post-surgical pain intensity will be measured by numerical rating scale (NRS) for pain

Full Information

First Posted
November 19, 2014
Last Updated
November 24, 2014
Sponsor
First Affiliated Hospital of Chongqing Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT02300480
Brief Title
Effects of Calot's Triangle Block for Postoperative Analgesia in Patients Undergoing Laparoscopic Cholecystectomy: a Prospective, Randomized, Double-blind, Controlled, 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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2014
Overall Recruitment Status
Unknown status
Study Start Date
December 2014 (undefined)
Primary Completion Date
August 2015 (Anticipated)
Study Completion Date
November 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
First Affiliated Hospital of Chongqing Medical University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-operative Pain, Gallstone Disease
Keywords
pain, calot's triangle, local block, analgesia, patient controlled intravenous analgesia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
140 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CTB group
Arm Type
Experimental
Arm Description
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.
Arm Title
PCIA group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
CTB group
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
PCIA group
Intervention Description
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 Measure Information:
Title
Chronic post-surgical pain
Description
Chronic post-surgical pain intensity will be measured as more than 3 months by numerical rating scale (NRS) for pain
Time Frame
3 months post-operatively
Secondary Outcome Measure Information:
Title
Acute pain post-operatively
Description
Pain intensity will be measured by visual analogue scale(VAS)
Time Frame
2h,4h,6h,12h,24h, 48h post-operatively
Title
Analgesic Rescue
Description
The dosages of opioid or non-opioid analgesic rescue medications
Time Frame
from 2h to 48h post-operatively
Title
Adverse events associated with post-operative analgesia
Description
incomplete analgesia; nausea and vomiting; respiratory depression; over-sedation
Time Frame
from 2h to 48h post-operatively
Title
moderate-severe pain
Description
Pain intensity will be measured by numerical rating scale (NRS)
Time Frame
3,6months postoperatively
Title
chronic post-surgical pain
Description
chronic post-surgical pain intensity will be measured by numerical rating scale (NRS) for pain
Time Frame
6months postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dong Zhang, Master
Phone
+86-23-89011061
Email
zdcqmua420@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Su Min, MD
Organizational Affiliation
First Affiliated Hospital of Chongqing Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
China,Chongqing The First Affiliated Hospital of Chongqing Medical University
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400016
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Su Min, MD
Phone
+86-23-89011068
Email
ms89011068@163.com
First Name & Middle Initial & Last Name & Degree
Dong Zhang, Master
Phone
+86-23-89011061
Email
zdcqmua420@163.com

12. IPD Sharing Statement

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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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