Pain, PostoperativeNCT01388946
Analgesia in Laparoscopic Cholecystectomy
A study testing Ropivacaine 0.75 and Normal saline in people with Pain, Postoperative and Chronic Postoperative Pain, run by University of Athens at 2 sites in Greece.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Pain, Postoperative, Chronic Postoperative Pain
- What is being tested?
- Ropivacaine 0.75 and Normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- 2 sitesGreece
- Study dates
- May 2010to Jan 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 30-70 years American Society of Anesthesiology (ASA) physical status I-III
- Scheduled for laparoscopic cholecystectomy
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Greece2 sites
Department of Anesthesia, St Savas Hospital
Athens, 11522
Aretaieio Hospital
Athens, 11528
About this study
Official title: Perioperative Ropivacaine Wound Infusion in Laparoscopic Cholecystectomy. A Randomized Controlled Double-blind Trial
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.
Read the 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.
- Conditions
- Pain, Postoperative, Chronic Postoperative Pain
- Being tested
- Ropivacaine 0.75, Normal saline
- Keywords
- acute postoperative pain, late pain, chronic pain, wound irrigation with local anesthetic
- Medical subject headings
- Pain, Postoperative, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ropivacaine 0.75Drug
Also called Naropeine
Normal salineDrug
Also called 0.9% saline
| Study group | Role | What they receive |
|---|---|---|
| Ropivacaine 0.75 | Active comparator | Continuous infusion of ropivacaine 7.5 mg/ml, 2 ml/h for 24 hours Receives: Drug: Ropivacaine 0.75 |
| Normal saline | Placebo comparator | Continuous infusion of normal saline 2 ml/h for 24 hours Receives: Drug: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 h
Secondary outcomes (13)
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.
Measured: in PACU
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.
Measured: 2 h postoperatively
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.
Measured: 4 h
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.
Measured: 8 h
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.
Measured: 24h
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.
Measured: 48 h
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.
Measured: PACU
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.
Measured: 2 h
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.
Measured: 4 h
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.
Measured: 8 h
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.
Measured: 48 h
Chronic Pain
Number and incidence of patients with persisting pain (burning pain, loss of sensation) one month postoperatively
Measured: one month postoperatively
Chronic Pain
Number and incidence of patients with persisting pain (burning pain, loss of sensation) three month postoperatively
Measured: three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2011 (estimated)
- Study startMay 2010
- Primary completionJan 2014
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Athens
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Argyro Fassoulaki, University of Athens
- Investigators
- Emilia Vassi, Principal investigator, St Savvas Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01388946
- Sponsor's protocol ID
- 149/27.5.10 & Σ-147/03-08-10
- Status last verified
- Jul 2016
- First submitted
- 29 Jun 2011
- Last updated
- 6 Jul 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No: No plan to share data. The study has been published
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Ropivacaine Wound Infusion in Laparoscopic Cholecystectomy. A Randomized Controlled Double-blind Trial
- ClinicalTrials.gov ID
- NCT01388946
- Acronym / sponsor ID
- 149/27.5.10 & Σ-147/03-08-10
- Conditions
- Pain, Postoperative, Chronic Postoperative Pain
- Keywords
- acute postoperative pain, late pain, chronic pain, wound irrigation with local anesthetic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- University of AthensUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 7 Jul 2011 (estimated)
- Results
- Posted 6 Jul 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ropivacaine 0.75 | Active comparator | Drug: Ropivacaine 0.75Continuous infusion of ropivacaine 7.5 mg/ml, 2 ml/h for 24 hours |
| Normal saline | Placebo comparator | Drug: Normal salineContinuous infusion of normal saline 2 ml/h for 24 hours |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients aged 30-70 years American Society of Anesthesiology (ASA) physical status I-III
- Scheduled for laparoscopic cholecystectomy
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ropivacaine 0.75Also: Naropeine | Drug | Ropivacaine 0.75 |
| Normal salineAlso: 0.9% saline | Drug | Normal saline |
Primary outcome
VAS Score Changes ( Cough) During 24 h Postoperatively
Time frame: 24 h
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.
13 secondary outcomes
Pain Scores in the Postoperative Care Unit (PACU) at Rest
Time frame: in PACU
Pain Scores at Rest 2 h Postoperatively
Time frame: 2 h postoperatively
Pain Scores at Rest 4 h Postoperatively
Time frame: 4 h
Pain Scores at Rest 8 h Postoperatively
Time frame: 8 h
Pain Scores at Rest 24 h Postoperatively
Time frame: 24h
Pain Scores at Rest 48 h Postoperatively
Time frame: 48 h
Pain Scores During Cough in the PACU
Time frame: PACU
Pain Scores During Cough 2 h Postoperatively
Time frame: 2 h
Pain Scores During Cough 4 h Postoperatively
Time frame: 4 h
Pain Scores During Cough 8 h Postoperatively
Time frame: 8 h
Pain Scores During Cough 48 h Postoperatively
Time frame: 48 h
Chronic Pain
Time frame: one month postoperatively
Chronic Pain
Time frame: three months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. No plan to share data. The study has been published
Related trials for Pain, Postoperative
RecruitingPhase 4
Anrikefon-based Patient-controlled Intravenous Analgesia Following Laparoscopic Surgery
Laparoscopic Surgery, Visceral Pain, Postoperative
Recruiting
NOL Guided Analgesia During Elective Laparoscopic Surgery Under General Anesthesia
Intraoperative Analgesia
Recruiting
Aescin-Based Herbal Extract (Reparil) for Postoperative Sequelae After Mandibular Third Molar Surgery
Postoperative Pain, Facial Swelling
Recruiting
Effect of Ultrasonic and Diode Laser Activated Irrigation on Postoperative Pain Following Root Canal Treatment
Symptomatic Irreversible Pulpitis and Symptomatic Apical Periodontitis
Not yet recruiting
Opioid Reduction and Enhanced Recovery in Orthopaedic Surgery (OREOS)-Knee
Knee Arthroplasty, Total, Partial Knee Arthroplasty
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emilia Vassi principal investigator
St Savvas Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ropivacaine 0.75 and Normal saline in people with Pain, Postoperative and Chronic Postoperative Pain, run by University of Athens at 2 sites in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Jul 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VAS Score Changes ( Cough) During 24 h Postoperatively (time frame: 24 h). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2016.