Analgesia in Laparoscopic Cholecystectomy
Primary Purpose
Pain, Postoperative, Chronic Postoperative Pain
Status
Completed
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
Ropivacaine 0.75
Normal saline
Sponsored by
About this trial
This is an interventional treatment trial for Pain, Postoperative focused on measuring acute postoperative pain, late pain, chronic pain, wound irrigation with local anesthetic
Eligibility Criteria
Inclusion Criteria:
- Patients aged 30-70 years American Society of Anesthesiology (ASA) physical status I-III
- Scheduled for laparoscopic cholecystectomy
Exclusion Criteria:
- Patients with chronic pain and/or on analgesics for the last month,
- Patients with central nervous, kidney and liver disease, or allergy to local anesthetics
Sites / Locations
- Department of Anesthesia, St Savas Hospital
- Aretaieio Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Ropivacaine 0.75
Normal saline
Arm Description
Continuous infusion of ropivacaine 7.5 mg/ml, 2 ml/h for 24 hours
Continuous infusion of normal saline 2 ml/h for 24 hours
Outcomes
Primary Outcome Measures
VAS Score Changes ( Cough) During 24 h Postoperatively
Visual Analogue Scale (VAS) measuring pain intensity (mm) with total range 0-100 and with 0 representing no pain and 100 representing possible worst pain.
Secondary Outcome Measures
Pain Scores in the Postoperative Care Unit (PACU) at Rest
Visual Analogue Scale (VAS) measuring pain intensity (mm) with total range 0-100 and with 0 representing no pain and 100 representing possible worst pain.
Pain Scores at Rest 2 h Postoperatively
Visual Analogue Scale (VAS) measuring pain intensity (mm) with total range 0-100 and with 0 representing no pain and 100 representing possible worst pain.
Pain Scores at Rest 4 h Postoperatively
Visual Analogue Scale (VAS) measuring pain intensity (mm) with total range 0-100 and with 0 representing no pain and 100 representing possible worst pain.
Pain Scores at Rest 8 h Postoperatively
Visual Analogue Scale (VAS) measuring pain intensity (mm) with total range 0-100 and with 0 representing no pain and 100 representing possible worst pain.
Pain Scores at Rest 24 h Postoperatively
Visual Analogue Scale (VAS) measuring pain intensity (mm) with total range 0-100 and with 0 representing no pain and 100 representing possible worst pain.
Pain Scores at Rest 48 h Postoperatively
Visual Analogue Scale (VAS) measuring pain intensity (mm) with total range 0-100 and with 0 representing no pain and 100 representing possible worst pain.
Pain Scores During Cough in the PACU
Visual Analogue Scale (VAS) measuring pain intensity (mm) with total range 0-100 and with 0 representing no pain and 100 representing possible worst pain.
Pain Scores During Cough 2 h Postoperatively
Visual Analogue Scale (VAS) measuring pain intensity (mm) with total range 0-100 and with 0 representing no pain and 100 representing possible worst pain.
Pain Scores During Cough 4 h Postoperatively
Visual Analogue Scale (VAS) measuring pain intensity (mm) with total range 0-100 and with 0 representing no pain and 100 representing possible worst pain.
Pain Scores During Cough 8 h Postoperatively
Visual Analogue Scale (VAS) measuring pain intensity (mm) with total range 0-100 and with 0 representing no pain and 100 representing possible worst pain.
Pain Scores During Cough 48 h Postoperatively
Visual Analogue Scale (VAS) measuring pain intensity (mm) with total range 0-100 and with 0 representing no pain and 100 representing possible worst pain.
Chronic Pain
Number and incidence of patients with persisting pain (burning pain, loss of sensation) one month postoperatively
Chronic Pain
Number and incidence of patients with persisting pain (burning pain, loss of sensation) three month postoperatively
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01388946
Brief Title
Analgesia in Laparoscopic Cholecystectomy
Official Title
Perioperative Ropivacaine Wound Infusion in Laparoscopic Cholecystectomy. A Randomized Controlled Double-blind Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
January 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Athens
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The investigators hypothesis is that perioperative infusion of 0.75 ropivacaine in patients undergoing laparoscopic cholecystectomy may modify the intensity of postoperative pain or the analgesic consumption during the first 24 hours.
Detailed Description
Patients scheduled for laparoscopic cholecystectomy were randomly assigned to receive via a subcutaneous catheter 2 ml per hour of 0.75 ropivacaine or same volume of normal saline. The catheter was inserted after induction of general anesthesia and before beginning of surgery and continued for the first 24 postoperative hours. The solutions were administered by means of an elastomeric pump. Before induction of anesthesia metoclopramide 10 mg, ranitidine 50 mg and droperidol 0.75 mg were given intravenously. In the operating room the routine monitoring was applied. Anesthesia was induced with thiopental 5-6 mg/kg, fentanyl 2 μg/kg, and rocuronium 0.6 mg/kg, and maintained with sevoflurane 1-1.5 Minimum Alveolar Concentration (MAC) in a nitrous oxide/oxygen mixture. After induction of anesthesia diclofenac 75 mg I.V was given within 30 min. Before wound closure each hole was infiltrated with 2 ml of ropivacaine 0.75 or normal saline. At the end of surgery neuromuscular block was reversed with sugammadex 2 mg/kg., the patient was extubated and transferred to the Post-anesthesia Care Unit (PACU).
Intra-operatively, the intra-abdominal pressure, the rate of carbon dioxide insufflation and the total amount of carbon dioxide insufflated are recorded every 5 minutes.
Besides the ropivacaine infusion in the operative site, postoperative analgesia is assured in the PACU with paracetamol 1 gr and tramadol 100 mg if Visual Analogue Scale (VAS) score is above 40 mm.In the ward Lonarid tablets are given instead.
VAS values and analgesic consumption are recorded in the PACU, and 2, 4, 8, 24 and 48 hours after surgery.
The catheter is removed 24 hours after surgery. One and three months after surgery patients are interviewed by phone for the presence of pain due to surgery.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative, Chronic Postoperative Pain
Keywords
acute postoperative pain, late pain, chronic pain, wound irrigation with local anesthetic
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
110 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ropivacaine 0.75
Arm Type
Active Comparator
Arm Description
Continuous infusion of ropivacaine 7.5 mg/ml, 2 ml/h for 24 hours
Arm Title
Normal saline
Arm Type
Placebo Comparator
Arm Description
Continuous infusion of normal saline 2 ml/h for 24 hours
Intervention Type
Drug
Intervention Name(s)
Ropivacaine 0.75
Other Intervention Name(s)
Naropeine
Intervention Type
Drug
Intervention Name(s)
Normal saline
Other Intervention Name(s)
0.9% saline
Primary Outcome Measure Information:
Title
VAS Score Changes ( Cough) During 24 h Postoperatively
Description
Visual Analogue Scale (VAS) measuring pain intensity (mm) with total range 0-100 and with 0 representing no pain and 100 representing possible worst pain.
Time Frame
24 h
Secondary Outcome Measure Information:
Title
Pain Scores in the Postoperative Care Unit (PACU) at Rest
Description
Visual Analogue Scale (VAS) measuring pain intensity (mm) with total range 0-100 and with 0 representing no pain and 100 representing possible worst pain.
Time Frame
in PACU
Title
Pain Scores at Rest 2 h Postoperatively
Description
Visual Analogue Scale (VAS) measuring pain intensity (mm) with total range 0-100 and with 0 representing no pain and 100 representing possible worst pain.
Time Frame
2 h postoperatively
Title
Pain Scores at Rest 4 h Postoperatively
Description
Visual Analogue Scale (VAS) measuring pain intensity (mm) with total range 0-100 and with 0 representing no pain and 100 representing possible worst pain.
Time Frame
4 h
Title
Pain Scores at Rest 8 h Postoperatively
Description
Visual Analogue Scale (VAS) measuring pain intensity (mm) with total range 0-100 and with 0 representing no pain and 100 representing possible worst pain.
Time Frame
8 h
Title
Pain Scores at Rest 24 h Postoperatively
Description
Visual Analogue Scale (VAS) measuring pain intensity (mm) with total range 0-100 and with 0 representing no pain and 100 representing possible worst pain.
Time Frame
24h
Title
Pain Scores at Rest 48 h Postoperatively
Description
Visual Analogue Scale (VAS) measuring pain intensity (mm) with total range 0-100 and with 0 representing no pain and 100 representing possible worst pain.
Time Frame
48 h
Title
Pain Scores During Cough in the PACU
Description
Visual Analogue Scale (VAS) measuring pain intensity (mm) with total range 0-100 and with 0 representing no pain and 100 representing possible worst pain.
Time Frame
PACU
Title
Pain Scores During Cough 2 h Postoperatively
Description
Visual Analogue Scale (VAS) measuring pain intensity (mm) with total range 0-100 and with 0 representing no pain and 100 representing possible worst pain.
Time Frame
2 h
Title
Pain Scores During Cough 4 h Postoperatively
Description
Visual Analogue Scale (VAS) measuring pain intensity (mm) with total range 0-100 and with 0 representing no pain and 100 representing possible worst pain.
Time Frame
4 h
Title
Pain Scores During Cough 8 h Postoperatively
Description
Visual Analogue Scale (VAS) measuring pain intensity (mm) with total range 0-100 and with 0 representing no pain and 100 representing possible worst pain.
Time Frame
8 h
Title
Pain Scores During Cough 48 h Postoperatively
Description
Visual Analogue Scale (VAS) measuring pain intensity (mm) with total range 0-100 and with 0 representing no pain and 100 representing possible worst pain.
Time Frame
48 h
Title
Chronic Pain
Description
Number and incidence of patients with persisting pain (burning pain, loss of sensation) one month postoperatively
Time Frame
one month postoperatively
Title
Chronic Pain
Description
Number and incidence of patients with persisting pain (burning pain, loss of sensation) three month postoperatively
Time Frame
three months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients aged 30-70 years American Society of Anesthesiology (ASA) physical status I-III
Scheduled for laparoscopic cholecystectomy
Exclusion Criteria:
Patients with chronic pain and/or on analgesics for the last month,
Patients with central nervous, kidney and liver disease, or allergy to local anesthetics
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emilia Vassi
Organizational Affiliation
St Savvas Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Anesthesia, St Savas Hospital
City
Athens
ZIP/Postal Code
11522
Country
Greece
Facility Name
Aretaieio Hospital
City
Athens
ZIP/Postal Code
11528
Country
Greece
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
No plan to share data. The study has been published
Learn more about this trial
Analgesia in Laparoscopic Cholecystectomy
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