Pain, PostoperativePhase 3COALASNCT03667001
Comparing Analgesic Efficacy of Systemic Lidocaine Against Placebo in General Anesthesia in Bariatric Surgery
A Phase 3 study testing Lidocaine Hydrochloride and Saline Solution in people with Pain, Postoperative, run by Miodrag Filipovic, Prof. Dr. med. at 1 site in Switzerland.
Trial summary
The investigators plan to evaluate the analgesic effect of systemic Lidocaine in addition to general anesthesia during bariatric surgery. Patients will be subdivided into a "Lidocaine group" and a "Control group". Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- Lidocaine Hydrochloride and Saline Solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- 1 siteSwitzerland
- Study dates
- 16 Nov 2018to 1 Apr 2021
- Phase
- Phase 3
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- elective laparoscopic bariatric surgery
- ASA classification I - III
- age 18 - 80
- given informed consent
Who cannot join
- no written consent
- allergy to the investigational product
- cardiac arrhythmia (pacemaker)
- liver dysfunction (Child-Pugh classification A, B or C)
- pregnancy
- central nervous disease
Show all 9Show fewer
- chronic pain and pre-existing opiate prescription
- expected non-compliance
- drug/alcohol abuse
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparing Analgesic Efficacy of Systemic Lidocaine Against Placebo in General Anesthesia in Bariatric Surgery: Prospective, Randomized, Double-blinded, Placebo Controlled, Mono-Center Study
The investigators plan to evaluate the analgesic effect of systemic Lidocaine in addition to general anesthesia during bariatric surgery. Patients will be subdivided into a "Lidocaine group" and a "Control group".
The primary outcome will be the proportion of patients suffering from higher pain intensity within the first four hours after bariatric surgery.
Secondary outcomes include the average maximal pain intensity during first four hours and during 48 hours, total opiate consumption, occurence of postoperative nausea and vomiting, time to first defecation and total time spent in hospital.
Read the detailed description
Postoperative pain is a common problem in today's surgery, although pain management techniques have improved in the last years. Systemic application of lidocaine has gained interest since several studies have shown its analgesic, anti-inflammatory and antihyperalgesic properties. In this clinical trial the analgesic effect of intravenously administrated lidocaine is compared with placebo. Despite longstanding use as an antiarrhythmic agent and its use in many clinical trial as analgesic, lidocaine is not licensed for this indication and application. Current studies, setting the focus on abdominal surgery, indicated that the systemic application of lidocaine was associated with fewer intensity of pain at rest and during mobilization and resulted in a decrease of patients'opiate consumption.
The intervention to be studied will either be the additional application of systemic lidocaine 1% to general anesthesia in bariatric surgery or the application of placebo. Patients, randomly assigned to one study group, will be surveyed for 48 hours after completion of surgery, experienced pain, occurrence of PONV, time to first defecation and length of hospitalization will be monitored. The population to be studied will include 140 patients listed for bariatric surgery at the Kantonsspital St. Gallen. Patients, medical practitioner, nurses and investigators will be blinded. Each patient will self-evaluate his maximal experienced pain eight-hourly during a sequence of 48 hours after completion of surgery.
- Conditions
- Pain, Postoperative
- Being tested
- Lidocaine Hydrochloride, Saline Solution
- Keywords
- systemic lidocain
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lidocaine HydrochlorideDrug
Also called Lidocaine Group
The intervention to be studied will be the additional application of systemic lidocaine 1% dosed 1.5 ml/kg LBM to general anesthesia in bariatric surgery. Patients, randomly assigned to one study group, will be surveyed for 48 hours after completion of surgery, experienced pain, occurrence of PONV, time to first defecation and length of hospitalization will be monitored. Patients, medical practitioner, nurses and investigators will be blinded by utilization of equal appearance and packing of IMPs, which will be fabricated individually for each patient and on request one to two days before surgery by the pharmacy. Each patient will self-evaluate his maximal experienced pain eight-hourly during a sequence of 48 hours after completion of surgery.
Saline SolutionDrug
Also called Placebo Group
The intervention to be studied will be the additional application of NaCl 0.9% dosed 1.5 ml/kg LBM to general anesthesia in bariatric surgery as a placebo. Patients, randomly assigned to one study group, will be surveyed for 48 hours after completion of surgery, experienced pain, occurrence of PONV, time to first defecation and length of hospitalization will be monitored. Each patient will self-evaluate his maximal experienced pain eight-hourly during a sequence of 48 hours after completion of surgery.
| Study group | Role | What they receive |
|---|---|---|
| Lidocaine Hydrochloride | Experimental | * 1.5 mg/kg lean body mass lidocaine (lidocaine 1%) bolus I.V. as general anesthesia steady state concentration is accomplished
* 1.5 mg/kg lean body mass/h lidocaine I.V. with beginning of surgical procedures
* after completion of surgery: transfer to PACU, pain evaluation for 48 hours
* duration of intervention: lidocaine infusion up to four hours from completion of surgery, or till transfer to surgical ward Receives: Drug: Lidocaine Hydrochloride |
| Saline Solution | Placebo comparator | * 0.15 ml/kg lean body mass saline 0.9% bolus I.V. as general anesthesia steady state concentration is accomplished
* 0.15 ml/kg lean body mass/h saline 0.9% I.V. with beginning of surgical procedure
* after completion of surgery: transfer to PACU, pain evaluation for 48 hours
* duration of intervention: saline infusion up to four hours from completion of surgery, or till transfer to surgical ward Receives: Drug: Saline Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative VAS/NRS Score
Any development of VAS/NRS score > 3 (Visual Analog Scale/Numeric Rating Scale ranging from minimum 0 to maximum 10 points, with 0 points as "no pain" to 10 points as "severe pain") , in hourly measurements within the first four hours after completion of bariatric surgery to evaluate the pain experienced by patients after the surgical intervention
Measured: 0 - 4 hours after surgery
Secondary outcomes (5)
Average experienced maximal pain during the first four hours and 48 hours after Surgery
Average experienced maximal pain during the first four hours and 48 hours (in hourly measurements on post anesthesia care unit (PACU) and in eight-hourly measurements on surgical ward) is assessed by VAS/NRS score (Visual Analog Scale/Numeric Rating Scale ranging from minimum 0 to maximum 10 points, with 0 points as "no pain" to 10 points as "severe pain").
Measured: 0 - 48 hours after surgery
Occurence of Postoperative Nausea and Vomiting after Surgery
Any event of postoperative nausea and vomiting (PONV) (subdivided by event of no nausea (PONV = 0), event of nausea without vomiting (PONV = 1) and event of nausea with vomiting (PONV = 2)) during first 48 hours after completion of surgery
Measured: 0 - 48 hours after surgery
Time to first Defecation
Time to first defecation (quantified in hours)
Measured: 0 - 48 hours after surgery
Duration of Hospitalization
Duration of hospitalization (quantified in days)
Measured: 0 - 48 hours after surgery
Total Amount of Opiate Consumption
The total amount of opiates (given during surgery and on PACU and administrated by nurse controlled analgesia on surgical ward)
Measured: 0 - 48 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2018
- Study start16 Nov 2018
- Primary completion1 Apr 2021
- Study completion1 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The investigators plan to evaluate the analgesic effect of systemic Lidocaine in Addition to general anesthesia during bariatric surgery. * Lidocaine group: perioperative application of systemic Lidocaine up to four hours from end of surgical procedures. * Control group: perioperative application of Placebo (NaCl 0.9%) up to four hours from end of surgical procedures.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Miodrag Filipovic, Prof. Dr. med.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Miodrag Filipovic, Prof. Dr. med., Cantonal Hospital of St. Gallen
- Investigators
- Miodrag Filipovic, Prof.Dr.med., Principal investigator, Deputy Head of the Clinic for Anesthesiology & Intensive Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03667001
- Sponsor's protocol ID
- CTU 17/026
- Acronym
- COALAS
- Status last verified
- Jul 2021
- First submitted
- 24 Aug 2018
- Last updated
- 28 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
McCarthy GC, Megalla SA, Habib AS. Impact of intravenous lidocaine infusion on postoperative analgesia and recovery from surgery: a systematic review of randomized controlled trials. Drugs. 2010 Jun 18;70(9):1149-63. doi: 10.2165/10898560-000000000-00000.
PubMed 20518581Vigneault L, Turgeon AF, Cote D, Lauzier F, Zarychanski R, Moore L, McIntyre LA, Nicole PC, Fergusson DA. Perioperative intravenous lidocaine infusion for postoperative pain control: a meta-analysis of randomized controlled trials. Can J Anaesth. 2011 Jan;58(1):22-37. doi: 10.1007/s12630-010-9407-0.
PubMed 21061107Cui W, Li Y, Li S, Wang R, Li J. Systemic administration of lidocaine reduces morphine requirements and postoperative pain of patients undergoing thoracic surgery after propofol-remifentanil-based anaesthesia. Eur J Anaesthesiol. 2010 Jan;27(1):41-6. doi: 10.1097/EJA.0b013e32832d5426.
PubMed 19478674Herroeder S, Pecher S, Schonherr ME, Kaulitz G, Hahnenkamp K, Friess H, Bottiger BW, Bauer H, Dijkgraaf MG, Durieux ME, Hollmann MW. Systemic lidocaine shortens length of hospital stay after colorectal surgery: a double-blinded, randomized, placebo-controlled trial. Ann Surg. 2007 Aug;246(2):192-200. doi: 10.1097/SLA.0b013e31805dac11.
PubMed 17667496Groudine SB, Fisher HA, Kaufman RP Jr, Patel MK, Wilkins LJ, Mehta SA, Lumb PD. Intravenous lidocaine speeds the return of bowel function, decreases postoperative pain, and shortens hospital stay in patients undergoing radical retropubic prostatectomy. Anesth Analg. 1998 Feb;86(2):235-9. doi: 10.1097/00000539-199802000-00003.
PubMed 9459225Weibel S, Jokinen J, Pace NL, Schnabel A, Hollmann MW, Hahnenkamp K, Eberhart LH, Poepping DM, Afshari A, Kranke P. Efficacy and safety of intravenous lidocaine for postoperative analgesia and recovery after surgery: a systematic review with trial sequential analysis. Br J Anaesth. 2016 Jun;116(6):770-83. doi: 10.1093/bja/aew101.
PubMed 27199310De Oliveira GS Jr, Duncan K, Fitzgerald P, Nader A, Gould RW, McCarthy RJ. Systemic lidocaine to improve quality of recovery after laparoscopic bariatric surgery: a randomized double-blinded placebo-controlled trial. Obes Surg. 2014 Feb;24(2):212-8. doi: 10.1007/s11695-013-1077-x.
PubMed 24036842Janmahasatian S, Duffull SB, Ash S, Ward LC, Byrne NM, Green B. Quantification of lean bodyweight. Clin Pharmacokinet. 2005;44(10):1051-65. doi: 10.2165/00003088-200544100-00004.
PubMed 16176118Yurttas T, Djurdjevic M, Schnider TW, Filipovic M. Analgesic efficacy of systemic lidocaine using lean body mass based dosing regime versus placebo in bariatric surgery: a prospective, randomised, double-blind, placebo-controlled, single-centre study. Br J Anaesth. 2023 Jul;131(1):122-129. doi: 10.1016/j.bja.2023.03.027. Epub 2023 May 12.
PubMed 37183098
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Analgesic Efficacy of Systemic Lidocaine Against Placebo in General Anesthesia in Bariatric Surgery: Prospective, Randomized, Double-blinded, Placebo Controlled, Mono-Center Study
- ClinicalTrials.gov ID
- NCT03667001
- Acronym / sponsor ID
- COALAS / CTU 17/026
- Conditions
- Pain, Postoperative
- Keywords
- systemic lidocain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Miodrag Filipovic, Prof. Dr. med.University, hospital or other
- Study start
- 16 Nov 2018 (actual)
- Primary completion
- 1 Apr 2021 (actual)
- Study completion
- 1 Apr 2021 (actual)
- First posted
- 12 Sep 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 investigators plan to evaluate the analgesic effect of systemic Lidocaine in addition to general anesthesia during bariatric surgery. Patients will be subdivided into a "Lidocaine group" and a "Control group".
The primary outcome will be the proportion of patients suffering from higher pain intensity within the first four hours after bariatric surgery.
Secondary outcomes include the average maximal pain intensity during first four hours and during 48 hours, total opiate consumption, occurence of postoperative nausea and vomiting, time to first defecation and total time spent in hospital.
Detailed description
Postoperative pain is a common problem in today's surgery, although pain management techniques have improved in the last years. Systemic application of lidocaine has gained interest since several studies have shown its analgesic, anti-inflammatory and antihyperalgesic properties. In this clinical trial the analgesic effect of intravenously administrated lidocaine is compared with placebo. Despite longstanding use as an antiarrhythmic agent and its use in many clinical trial as analgesic, lidocaine is not licensed for this indication and application. Current studies, setting the focus on abdominal surgery, indicated that the systemic application of lidocaine was associated with fewer intensity of pain at rest and during mobilization and resulted in a decrease of patients'opiate consumption.
The intervention to be studied will either be the additional application of systemic lidocaine 1% to general anesthesia in bariatric surgery or the application of placebo. Patients, randomly assigned to one study group, will be surveyed for 48 hours after completion of surgery, experienced pain, occurrence of PONV, time to first defecation and length of hospitalization will be monitored. The population to be studied will include 140 patients listed for bariatric surgery at the Kantonsspital St. Gallen. Patients, medical practitioner, nurses and investigators will be blinded. Each patient will self-evaluate his maximal experienced pain eight-hourly during a sequence of 48 hours after completion of surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The investigators plan to evaluate the analgesic effect of systemic Lidocaine in Addition to general anesthesia during bariatric surgery. * Lidocaine group: perioperative application of systemic Lidocaine up to four hours from end of surgical procedures. * Control group: perioperative application of Placebo (NaCl 0.9%) up to four hours from end of surgical procedures.
| Arm | Type | Receives |
|---|---|---|
| Lidocaine Hydrochloride | Experimental | Drug: Lidocaine Hydrochloride* 1.5 mg/kg lean body mass lidocaine (lidocaine 1%) bolus I.V. as general anesthesia steady state concentration is accomplished * 1.5 mg/kg lean body mass/h lidocaine I.V. with beginning of surgical procedures * after completion of surgery: transfer to PACU, pain evaluation for 48 hours * duration of intervention: lidocaine infusion up to four hours from completion of surgery, or till transfer to surgical ward |
| Saline Solution | Placebo comparator | Drug: Saline Solution* 0.15 ml/kg lean body mass saline 0.9% bolus I.V. as general anesthesia steady state concentration is accomplished * 0.15 ml/kg lean body mass/h saline 0.9% I.V. with beginning of surgical procedure * after completion of surgery: transfer to PACU, pain evaluation for 48 hours * duration of intervention: saline infusion up to four hours from completion of surgery, or till transfer to surgical ward |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- elective laparoscopic bariatric surgery
- ASA classification I - III
- age 18 - 80
- given informed consent
Key exclusion criteria (9 listed)
- no written consent
- allergy to the investigational product
- cardiac arrhythmia (pacemaker)
- liver dysfunction (Child-Pugh classification A, B or C)
- pregnancy
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 |
|---|---|---|
| Lidocaine HydrochlorideAlso: Lidocaine GroupThe intervention to be studied will be the additional application of systemic lidocaine 1% dosed 1.5 ml/kg LBM to general anesthesia in bariatric surgery. Patients, randomly assigned to one study group, will be surveyed for 48 hours after completion of surgery, experienced pain, occurrence of PONV, time to first defecation and length of hospitalization will be monitored. Patients, medical practitioner, nurses and investigators will be blinded by utilization of equal appearance and packing of IMPs, which will be fabricated individually for each patient and on request one to two days before surgery by the pharmacy. Each patient will self-evaluate his maximal experienced pain eight-hourly during a sequence of 48 hours after completion of surgery. | Drug | Lidocaine Hydrochloride |
| Saline SolutionAlso: Placebo GroupThe intervention to be studied will be the additional application of NaCl 0.9% dosed 1.5 ml/kg LBM to general anesthesia in bariatric surgery as a placebo. Patients, randomly assigned to one study group, will be surveyed for 48 hours after completion of surgery, experienced pain, occurrence of PONV, time to first defecation and length of hospitalization will be monitored. Each patient will self-evaluate his maximal experienced pain eight-hourly during a sequence of 48 hours after completion of surgery. | Drug | Saline Solution |
Primary outcome
Postoperative VAS/NRS Score
Time frame: 0 - 4 hours after surgery
Any development of VAS/NRS score > 3 (Visual Analog Scale/Numeric Rating Scale ranging from minimum 0 to maximum 10 points, with 0 points as "no pain" to 10 points as "severe pain") , in hourly measurements within the first four hours after completion of bariatric surgery to evaluate the pain experienced by patients after the surgical intervention
5 secondary outcomes
Average experienced maximal pain during the first four hours and 48 hours after Surgery
Time frame: 0 - 48 hours after surgery
Occurence of Postoperative Nausea and Vomiting after Surgery
Time frame: 0 - 48 hours after surgery
Time to first Defecation
Time frame: 0 - 48 hours after surgery
Duration of Hospitalization
Time frame: 0 - 48 hours after surgery
Total Amount of Opiate Consumption
Time frame: 0 - 48 hours after surgery
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 28 Jul 2021.
- Background: PubMed 20518581McCarthy GC, Megalla SA, Habib AS. Impact of intravenous lidocaine infusion on postoperative analgesia and recovery from surgery: a systematic review of randomized controlled trials. Drugs. 2010 Jun 18;70(9):1149-63. doi: 10.2165/10898560-000000000-00000.
- Background: PubMed 21061107Vigneault L, Turgeon AF, Cote D, Lauzier F, Zarychanski R, Moore L, McIntyre LA, Nicole PC, Fergusson DA. Perioperative intravenous lidocaine infusion for postoperative pain control: a meta-analysis of randomized controlled trials. Can J Anaesth. 2011 Jan;58(1):22-37. doi: 10.1007/s12630-010-9407-0.
- Background: PubMed 19478674Cui W, Li Y, Li S, Wang R, Li J. Systemic administration of lidocaine reduces morphine requirements and postoperative pain of patients undergoing thoracic surgery after propofol-remifentanil-based anaesthesia. Eur J Anaesthesiol. 2010 Jan;27(1):41-6. doi: 10.1097/EJA.0b013e32832d5426.
- Background: PubMed 17667496Herroeder S, Pecher S, Schonherr ME, Kaulitz G, Hahnenkamp K, Friess H, Bottiger BW, Bauer H, Dijkgraaf MG, Durieux ME, Hollmann MW. Systemic lidocaine shortens length of hospital stay after colorectal surgery: a double-blinded, randomized, placebo-controlled trial. Ann Surg. 2007 Aug;246(2):192-200. doi: 10.1097/SLA.0b013e31805dac11.
- Background: PubMed 9459225Groudine SB, Fisher HA, Kaufman RP Jr, Patel MK, Wilkins LJ, Mehta SA, Lumb PD. Intravenous lidocaine speeds the return of bowel function, decreases postoperative pain, and shortens hospital stay in patients undergoing radical retropubic prostatectomy. Anesth Analg. 1998 Feb;86(2):235-9. doi: 10.1097/00000539-199802000-00003.
- Background: PubMed 27199310Weibel S, Jokinen J, Pace NL, Schnabel A, Hollmann MW, Hahnenkamp K, Eberhart LH, Poepping DM, Afshari A, Kranke P. Efficacy and safety of intravenous lidocaine for postoperative analgesia and recovery after surgery: a systematic review with trial sequential analysis. Br J Anaesth. 2016 Jun;116(6):770-83. doi: 10.1093/bja/aew101.
- Background: PubMed 24036842De Oliveira GS Jr, Duncan K, Fitzgerald P, Nader A, Gould RW, McCarthy RJ. Systemic lidocaine to improve quality of recovery after laparoscopic bariatric surgery: a randomized double-blinded placebo-controlled trial. Obes Surg. 2014 Feb;24(2):212-8. doi: 10.1007/s11695-013-1077-x.
- Background: PubMed 16176118Janmahasatian S, Duffull SB, Ash S, Ward LC, Byrne NM, Green B. Quantification of lean bodyweight. Clin Pharmacokinet. 2005;44(10):1051-65. doi: 10.2165/00003088-200544100-00004.
- Derived from this study: PubMed 37183098Yurttas T, Djurdjevic M, Schnider TW, Filipovic M. Analgesic efficacy of systemic lidocaine using lean body mass based dosing regime versus placebo in bariatric surgery: a prospective, randomised, double-blind, placebo-controlled, single-centre study. Br J Anaesth. 2023 Jul;131(1):122-129. doi: 10.1016/j.bja.2023.03.027. Epub 2023 May 12.
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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.
Miodrag Filipovic, Prof.Dr.med. principal investigator
Deputy Head of the Clinic for Anesthesiology & Intensive Care
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Lidocaine Hydrochloride and Saline Solution in people with Pain, Postoperative, run by Miodrag Filipovic, Prof. Dr. med. at 1 site in Switzerland.
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 4 inclusion and 9 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 28 Jul 2021. 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 Switzerland. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 VAS/NRS Score (time frame: 0 - 4 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03667001, which also lists 9 linked publications.
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 28 Jul 2021.