Postoperative PainNCT03620591
Lidocaine and Analgesia After Laparoscopic Cholecystectomy
A study testing Lidocaine in people with Postoperative Pain and Opioid Consumption, run by Larissa University Hospital at 1 site in Greece.
Trial summary
The purpose of this study is to evaluate how effective is the intraoperative use of lidocaine to attenuate postoperative pain and opioids consumption after laparoscopic cholecystectomy Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Pain, Opioid Consumption
- What is being tested?
- Lidocaine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 98 participants
- Where
- 1 siteGreece
- Study dates
- 2 Jul 2018to 31 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA physical status I-II
- Age ≥ 18 years old
- BMI ≤ 35
Who cannot join
- Allergy in local anesthetics
- History of liver, kidney or heart failure
- Existence of chronic pain history or daily analgesics
- Psychiatric disorders
- Inability to understand pain assessment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intraoperative Use of Lidocaine and Postoperative Analgesia After Laparoscopic Cholecystectomy
The purpose of this study is to evaluate how effective is the intraoperative use of lidocaine to attenuate postoperative pain and opioids consumption after laparoscopic cholecystectomy
Read the detailed description
Acute postoperative pain may predict the development of chronic pain.Recently, the analgesic effect of lidocaine, as a part of a multimodal analgesia, has been evaluated in many studies. They have shown that lidocaine may have a role in the postoperative pain management, as an adjunct.
Acute postoperative pain after laparoscopic cholecystectomy is complex in nature. Postoperative pain is the main complaint and the primary reason for delay discharge after laparoscopic cholecystectomy.The study includes patients undergoing laparoscopic cholecystectomy.
- Conditions
- Postoperative Pain, Opioid Consumption
- Being tested
- Lidocaine, Placebo
- Keywords
- Lidocaine, Postoperative Pain, Opioid consumption, Laparoscopic cholecystectomy
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LidocaineDrug
Intraoperative administration of lidocaine
PlaceboDrug
Intraoperative administration of normal saline
| Study group | Role | What they receive |
|---|---|---|
| Lidocaine | Active comparator | Intraoperative administration of lidocaine to patients undergo laparoscopic cholecystectomy.
Prior induction to anesthesia, lidocaine bolus 1.5 mg / kg will be administered to the lidocaine group and then patients will be connected to a continuous 2 mg / kg / h administration of lidocaine until the end of the procedure. Receives: Drug: Lidocaine |
| Placebo | Placebo comparator | Intraoperative administration of normal saline to patients undergo laparoscopic cholecystectomy. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative opioid consumption
The total dose of tramadol is calculated as mg and administered intravenously.
Measured: 24 hours after the procedure
Secondary outcomes (12)
Postoperative pain
Numeric Rate scale 0-10 (0=no pain to 10=worst imaginable pain)
Measured: Departure of the patient from the recovery room (0hrs)
Postoperative pain
Numeric Rate scale 0-10 (0=no pain to 10=worst imaginable pain)
Measured: 6 hrs after the procedure
Postoperative pain
Numeric Rate scale 0-10 (0=no pain to 10=worst imaginable pain)
Measured: 12 hrs after the procedure
Postoperative pain
Numeric Rate scale 0-10 (0=no pain to 10=worst imaginable pain)
Measured: 24 hrs after the procedure
Incidence of Nausea and Vomiting
The percentage of patients who had nausea and vomiting during the first 24 hours
Measured: 24 hours
Incidence of sedation and respiratory depression
The percentage of patients who had sedation and respiratory depression during the first 24 hours
Measured: 24 hours
Incidence of shoulder pain
The percentage of patients who had shoulder pain during the first24 hours
Measured: 24 hours
Incidence of headache and dizziness
The percentage of patients who had headache and dizziness during the first 24 hours
Measured: 24 hours
Change from baseline Mean Blood Pressure
Non-invasive blood pressure measurement by using sphygmomanometer cuff
Measured: Intraoperative
Change from Baseline Heart Rate
Bradycardia, tachycardia during the procedure
Measured: Intraoperative
Change in depth of anesthesia
Maintenance of Bispectral index (BIS) values of 40 to 50
Measured: Intraoperative
Side effect related to administration of lidocaine
The percentage of patients who had tremor, dizziness, dysarthria, agitation, hallucinations and drowsiness during the first 24 hours
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2018
- Study start2 Jul 2018
- Primary completion31 Jan 2022
- Study completion31 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Larissa University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ioannis Baloyiannis, Larissa University Hospital
- Investigators
- Ioannis Baloyiannis, Study director, University Hospital of LarissaChamaidi Sarakatsianou, Principal investigator, University Hospital of LarissaStavroula Georgopoulou, Study chair, University Hospital of Larissa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03620591
- Sponsor's protocol ID
- UHL27823/06/28/2018
- Status last verified
- Apr 2022
- First submitted
- 18 Jul 2018
- Last updated
- 5 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative Use of Lidocaine and Postoperative Analgesia After Laparoscopic Cholecystectomy
- ClinicalTrials.gov ID
- NCT03620591
- Acronym / sponsor ID
- UHL27823/06/28/2018
- Conditions
- Postoperative Pain, Opioid Consumption
- Keywords
- Lidocaine, Postoperative Pain, Opioid consumption, Laparoscopic cholecystectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Larissa University HospitalUniversity, hospital or other
- Study start
- 2 Jul 2018 (actual)
- Primary completion
- 31 Jan 2022 (actual)
- Study completion
- 31 Jan 2022 (actual)
- First posted
- 8 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate how effective is the intraoperative use of lidocaine to attenuate postoperative pain and opioids consumption after laparoscopic cholecystectomy
Detailed description
Acute postoperative pain may predict the development of chronic pain.Recently, the analgesic effect of lidocaine, as a part of a multimodal analgesia, has been evaluated in many studies. They have shown that lidocaine may have a role in the postoperative pain management, as an adjunct.
Acute postoperative pain after laparoscopic cholecystectomy is complex in nature. Postoperative pain is the main complaint and the primary reason for delay discharge after laparoscopic cholecystectomy.The study includes patients undergoing laparoscopic cholecystectomy.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lidocaine | Active comparator | Drug: LidocaineIntraoperative administration of lidocaine to patients undergo laparoscopic cholecystectomy. Prior induction to anesthesia, lidocaine bolus 1.5 mg / kg will be administered to the lidocaine group and then patients will be connected to a continuous 2 mg / kg / h administration of lidocaine until the end of the procedure. |
| Placebo | Placebo comparator | Drug: PlaceboIntraoperative administration of normal saline to patients undergo laparoscopic cholecystectomy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ASA physical status I-II
- Age ≥ 18 years old
- BMI ≤ 35
Key exclusion criteria (5 listed)
- Allergy in local anesthetics
- History of liver, kidney or heart failure
- Existence of chronic pain history or daily analgesics
- Psychiatric disorders
- Inability to understand pain assessment
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 |
|---|---|---|
| LidocaineIntraoperative administration of lidocaine | Drug | Lidocaine |
| PlaceboIntraoperative administration of normal saline | Drug | Placebo |
Primary outcome
Postoperative opioid consumption
Time frame: 24 hours after the procedure
The total dose of tramadol is calculated as mg and administered intravenously.
12 secondary outcomes
Postoperative pain
Time frame: Departure of the patient from the recovery room (0hrs)
Postoperative pain
Time frame: 6 hrs after the procedure
Postoperative pain
Time frame: 12 hrs after the procedure
Postoperative pain
Time frame: 24 hrs after the procedure
Incidence of Nausea and Vomiting
Time frame: 24 hours
Incidence of sedation and respiratory depression
Time frame: 24 hours
Incidence of shoulder pain
Time frame: 24 hours
Incidence of headache and dizziness
Time frame: 24 hours
Change from baseline Mean Blood Pressure
Time frame: Intraoperative
Change from Baseline Heart Rate
Time frame: Intraoperative
Change in depth of anesthesia
Time frame: Intraoperative
Side effect related to administration of lidocaine
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2022.
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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.
Ioannis Baloyiannis study director
University Hospital of Larissa
Chamaidi Sarakatsianou principal investigator
University Hospital of Larissa
Stavroula Georgopoulou study chair
University Hospital of Larissa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lidocaine in people with Postoperative Pain and Opioid Consumption, run by Larissa University Hospital at 1 site 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 3 inclusion and 5 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 5 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Postoperative opioid consumption (time frame: 24 hours after the procedure). 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 5 Apr 2022.