Pain, PostoperativePhase 4NCT04017013
Therapeutic Efficacy of Intravenous Lidocaine Infusion Compared With Epidural Analgesia for Postoperative Pain Control in Adult Patients Undergoing Major Abdominal Surgery: Non-Inferiority Clinical Trial
A Phase 4 study testing Epidural Analgesia and Lidocaine Infusion in people with Pain, Postoperative and Opioid Use, run by Universidad de Antioquia at 1 site in Colombia.
Trial summary
Major abdominal surgery continues is one of the most performed surgical procedures in the world, both electively and urgently. One of the main problems of this type of intervention is postoperative pain. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pain, Postoperative, Opioid Use
- What is being tested?
- Epidural Analgesia and Lidocaine Infusion
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 1 siteColombia
- Study dates
- 1 Mar 2020to 5 Sep 2022
- Phase
- Phase 4
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patient over 18 years.
- Elective major open intra-abdominal surgery:
- Cholecystectomy.
- Total or subtotal gastrectomy.
- Colectomy or Hemicolectomy.
- Pancreatoduodenectomy.
Show all 11Show fewer
- Hepatectomy 1 or 2 segments.
- Exploration and / or reconstruction of the bile duct.
- Abdominal demolition.
- Sigmoidectomy.
- Patient classified as ASA (American Association of Anesthesiology) 1, 2 or 3.
Who cannot join
- Pregnant woman
- Patient with contraindication for epidural analgesic techniques:
- Anticoagulated patient
- Active infection in the puncture site.
- Malformation in spinal cord.
- Sepsis without antibiotic treatment.
Show all 13Show fewer
- Patient with contraindication for the use of intravenous lidocaine: Arrhythmias of any type not treated.
- Patient with known allergy to opioids and / or local anesthetics.
- Patient with chronic pain in previous management with strong opioids, gabapentinoids or epidural technique.
- Patient with liver failure or terminal renal failure.
- Patient who is scheduled for intubated admission to an intensive care unit after the procedure.
- Patient who refuses to participate in the study or who refuses to receive epidural analgesia.
- Patient who was technically impossible to place an epidural catheter in surgery.
Trial locations and contacts
1 site in 1 country.
Colombia1 site
Antioquias Univervesity Health Institution
Medellín, Antioquia
About this study
Major abdominal surgery continues is one of the most performed surgical procedures in the world, both electively and urgently. One of the main problems of this type of intervention is postoperative pain. it is shown that it increases health costs related to longer recovery times, longer hospital stay and related complications such as the increased risk of presenting chronic POP pain, which it has been estimated up to 20%, much higher if the surgery involves surgery in the gastrointestinal system.
The goal of analgesia in the postoperative setting is precisely to provide comfort to patients, minimize adverse effects and complications arising from the procedure.
Read more
The epidural analgesic technique (has been proposed as an analgesic management standard, since multiple studies have shown that it reduces opioid consumption, improves recovery and is a useful strategy for pain control. However, it is an invasive technique, with risk of complications such as hematomas and epidural abscesses, and it may be difficult to perform.
Currently it has been shown in multiple studies that the intravenous infusion of a local anesthetic, such as lidocaine, in this type of surgical scenarios can reduce the intensity of pain, opioid consumption, hospital stay and ileus with few adverse effects. In addition, these studies propose that, being a less invasive technique, it could be easier to implement and even be safer than the epidural technique.
The main hypothesis of this study is precisely that the infusion of lidocaine may be non-inferior to epidural analgesia in the analgesic management of patients undergoing major abdominal surgery.
- Conditions
- Pain, Postoperative, Opioid Use
- Being tested
- Epidural Analgesia, Lidocaine Infusion
- Keywords
- Pain, Abdominal Surgery, Epidural analgesia, lidocaine
- Medical subject headings
- Pain, Postoperative, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epidural AnalgesiaProcedure or surgery
The epidural infusion will be as follows:
- Isobaric Bupivacaine 0.5% 40 cc
- Morphine 4 mg (1 ampoule up to 10 cc and 4 cc of the mixture will be applied)
- Saline solution 0.9% 156 cc.
- Total Volume: 200 cc.
This mixture will be prepared by a nurse outside the research group outside the operating room once indicated.
The infusion will be scheduled at 7 cc / hour per continuous infusion set and will be connected to the epidural catheter after its placement.
Lidocaine InfusionDrug
2% Lidocaine IV without epinephrine: 1 mg/kg/ hour for up to 24 hours, started immediately after anesthetic induction.
| Study group | Role | What they receive |
|---|---|---|
| Epidural Analgesia | Active comparator | The placement of the thoracic epidural catheter will be located depending on surgical incision as follows:
* Surgery of the upper abdomen: T7-T8.
* Surgery of lower abdomen: T8-T9. The epidural catheter placement technique will be determined by the treating anesthesiologist. However, once the epidural space is located and the respective catheter is inserted, the correct location of the catheter should be tested with lidocaine at 2% CE 5 cc and a sensitivity test with temperature should be performed on the target dermatomes. A negative test for an adequate location of the catheter indicates that the procedure should be repeated until the epidural space is correctly located. Once this is achieved, the catheter will be left 4 cm away from the skin. The catheter will be fixed according to the institutional protocol. Receives: Procedure: Epidural Analgesia |
| Lidocaine Infussion | Experimental | Intravenous lidocaine Receives: Drug: Lidocaine Infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Posoperative Pain
Numerical Rating Scale (NRS) for pain. The NRS for pain is a unidimensional measure of pain intensity in adults.The pain NRS is a single 11-point numeric scale. An 11-point numeric scale (NRS 11) with 0 representing one pain extreme (e.g., "no pain") and 10 representing the other pain extreme (e.g., "pain as bad as you can imagine" and "worst pain imaginable").
Measured: 24 hours after surgery
Secondary outcomes (6)
Posoperative Pain
Numerical Rating Scale (NRS) for pain. The NRS for pain is a unidimensional measure of pain intensity in adults.The pain NRS is a single 11-point numeric scale. An 11-point numeric scale (NRS 11) with 0 representing one pain extreme (e.g., "no pain") and 10 representing the other pain extreme (e.g., "pain as bad as you can imagine" and "worst pain imaginable").
Measured: 2, 6, 12, 48 and 72 hours after surgery
Posoperative opioid use
mg of morphine
Measured: 24 hours after surgery
Hospital Stay
days
Measured: From date of randomization until the date day of discharge or date of death from any cause, whichever came first, assessed up to 100 months
Perioperative Satisfaction
Evaluation du Vecu de l'Anesthesie Generale (EVAN G scale). The EVAN questionnaire is composed of 6 dimensions (attention, privacy, information, pain, discomfort and waiting times), which in turn consist of 26 items. Each item is evaluated with in an ordinal scale. The minimum value is 1, meaning the worst value for the item and the maximum value is 5, meaning the better value for the item.
Measured: 24 hours
Toxicity by local anesthetics proportion
Proportion of patients presenting signs of toxicity by local anesthetics.
- Metal taste
- Tinnitus
- Hypotension (SBP less than 80 mmHg)
- Tachycardia (FC greater than 130)
- Bradycardia (FC less than 40)
- Alterations of the mental state. It is positive for this outcome with 3 signs or if patient presents seizures or coma without a non-surgical or medical cause associated with the patient's clinical status.
Measured: 24 hours after surgery
Posoperative nausea and vomiting
Proportion of patients with at least one episode of nausea or vomiting in the postoperative period.
Measured: 24 hours after surgey
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2019
- Study start1 Mar 2020
- Primary completion5 Sep 2022
- Study completion5 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (26)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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- All patients who accept participation in the study and meet all inclusion criteria will be randomly assigned at the time of anesthetic induction. The assignment to the group of epidural analgesia vs IV lidocaine will be 1: 1 randomly using permuted blocks generated by a computer operated by an external assistant to the investigation. The size of the blocks will be variable between 4, 6, and 8, and will be kept confidential to guarantee the concealment of the groups.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Antioquia
- Sponsor type
- University, hospital or other
- Collaborators
- IPS Universitaria-Universidad de Antioquia
- Responsible party
- Sponsor
- Investigators
- Fabian Casas, Dr, Principal investigator, Univeridad de Antioquia's Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04017013
- Sponsor's protocol ID
- SIIU 2001-15550
- Status last verified
- May 2022
- First submitted
- 19 Jun 2019
- Last updated
- 26 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Shipton EA. The transition from acute to chronic post surgical pain. Anaesth Intensive Care. 2011 Sep;39(5):824-36. doi: 10.1177/0310057X1103900506.
PubMed 21970126Kranke P, Jokinen J, Pace NL, Schnabel A, Hollmann MW, Hahnenkamp K, Eberhart LH, Poepping DM, Weibel S. Continuous intravenous perioperative lidocaine infusion for postoperative pain and recovery. Cochrane Database Syst Rev. 2015 Jul 16;(7):CD009642. doi: 10.1002/14651858.CD009642.pub2.
PubMed 26184397Couceiro TC, Valenca MM, Lima LC, de Menezes TC, Raposo MC. Prevalence and influence of gender, age, and type of surgery on postoperative pain. Rev Bras Anestesiol. 2009 May-Jun;59(3):314-20. doi: 10.1590/s0034-70942009000300006. English, Portuguese.
PubMed 19488544Singh PK, Saikia P, Lahakar M. Prevalence of acute post-operative pain in patients in adult age-group undergoing inpatient abdominal surgery and correlation of intensity of pain and satisfaction with analgesic management: A cross-sectional single institute-based study. Indian J Anaesth. 2016 Oct;60(10):737-743. doi: 10.4103/0019-5049.191686.
PubMed 27761037Bouman EA, Theunissen M, Bons SA, van Mook WN, Gramke HF, van Kleef M, Marcus MA. Reduced incidence of chronic postsurgical pain after epidural analgesia for abdominal surgery. Pain Pract. 2014 Feb;14(2):E76-84. doi: 10.1111/papr.12091. Epub 2013 Jun 12.
PubMed 23758753Li M, Li L, Xu Y, Wang X. Intravenous analgesics for pain management in post- operative patients : a comparative study of their efficacy and adverse effects. 2016;15(August):1799-806.
Singh AP, Singh D, Singh Y, Jain G. Postoperative analgesic efficacy of epidural tramadol as adjutant to ropivacaine in adult upper abdominal surgeries. Anesth Essays Res. 2015 Sep-Dec;9(3):369-73. doi: 10.4103/0259-1162.161805.
PubMed 26712976Nworah U. From documentation to the problem: controlling postoperative pain. Nurs Forum. 2012 Apr-Jun;47(2):91-9. doi: 10.1111/j.1744-6198.2012.00262.x.
PubMed 22512766Sun Y, Li T, Wang N, Yun Y, Gan TJ. Perioperative systemic lidocaine for postoperative analgesia and recovery after abdominal surgery: a meta-analysis of randomized controlled trials. Dis Colon Rectum. 2012 Nov;55(11):1183-94. doi: 10.1097/DCR.0b013e318259bcd8.
PubMed 23044681Ventham NT, Kennedy ED, Brady RR, Paterson HM, Speake D, Foo I, Fearon KC. Efficacy of Intravenous Lidocaine for Postoperative Analgesia Following Laparoscopic Surgery: A Meta-Analysis. World J Surg. 2015 Sep;39(9):2220-34. doi: 10.1007/s00268-015-3105-6.
PubMed 26044546Kahokehr A, Sammour T, Soop M, Hill AG. Intraperitoneal local anaesthetic in abdominal surgery - a systematic review. ANZ J Surg. 2011 Apr;81(4):237-45. doi: 10.1111/j.1445-2197.2010.05573.x. Epub 2010 Nov 17.
PubMed 21418466Yu N, Long X, Lujan-Hernandez JR, Succar J, Xin X, Wang X. Transversus abdominis-plane block versus local anesthetic wound infiltration in lower abdominal surgery: a systematic review and meta-analysis of randomized controlled trials. BMC Anesthesiol. 2014 Dec 15;14:121. doi: 10.1186/1471-2253-14-121. eCollection 2014.
PubMed 25580086Ventham NT, Hughes M, O'Neill S, Johns N, Brady RR, Wigmore SJ. Systematic review and meta-analysis of continuous local anaesthetic wound infiltration versus epidural analgesia for postoperative pain following abdominal surgery. Br J Surg. 2013 Sep;100(10):1280-9. doi: 10.1002/bjs.9204.
PubMed 24244968Nimmo SM, Harrington LS. What is the role of epidural analgesia in abdominal surgery? Contin Educ Anaesthesia, Crit Care Pain. 2014;14(5):224-9.
Nishimori M, Ballantyne JC, Low JH. Epidural pain relief versus systemic opioid-based pain relief for abdominal aortic surgery. Cochrane Database Syst Rev. 2006 Jul 19;(3):CD005059. doi: 10.1002/14651858.CD005059.pub2.
PubMed 16856074
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Efficacy of Intravenous Lidocaine Infusion Compared With Epidural Analgesia for Postoperative Pain Control in Adult Patients Undergoing Major Abdominal Surgery: Non-Inferiority Clinical Trial
- ClinicalTrials.gov ID
- NCT04017013
- Acronym / sponsor ID
- SIIU 2001-15550
- Conditions
- Pain, Postoperative, Opioid Use
- Keywords
- Pain, Abdominal Surgery, Epidural analgesia, lidocaine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- Universidad de AntioquiaUniversity, hospital or other
- Collaborators
- IPS Universitaria-Universidad de Antioquia
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 5 Sep 2022 (actual)
- Study completion
- 5 Sep 2022 (actual)
- First posted
- 12 Jul 2019 (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.
Major abdominal surgery continues is one of the most performed surgical procedures in the world, both electively and urgently. One of the main problems of this type of intervention is postoperative pain. it is shown that it increases health costs related to longer recovery times, longer hospital stay and related complications such as the increased risk of presenting chronic POP pain, which it has been estimated up to 20%, much higher if the surgery involves surgery in the gastrointestinal system.
The goal of analgesia in the postoperative setting is precisely to provide comfort to patients, minimize adverse effects and complications arising from the procedure.
The epidural analgesic technique (has been proposed as an analgesic management standard, since multiple studies have shown that it reduces opioid consumption, improves recovery and is a useful strategy for pain control. However, it is an invasive technique, with risk of complications such as hematomas and epidural abscesses, and it may be difficult to perform.
Currently it has been shown in multiple studies that the intravenous infusion of a local anesthetic, such as lidocaine, in this type of surgical scenarios can reduce the intensity of pain, opioid consumption, hospital stay and ileus with few adverse effects. In addition, these studies propose that, being a less invasive technique, it could be easier to implement and even be safer than the epidural technique.
The main hypothesis of this study is precisely that the infusion of lidocaine may be non-inferior to epidural analgesia in the analgesic management of patients undergoing major abdominal surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- All patients who accept participation in the study and meet all inclusion criteria will be randomly assigned at the time of anesthetic induction. The assignment to the group of epidural analgesia vs IV lidocaine will be 1: 1 randomly using permuted blocks generated by a computer operated by an external assistant to the investigation. The size of the blocks will be variable between 4, 6, and 8, and will be kept confidential to guarantee the concealment of the groups.
| Arm | Type | Receives |
|---|---|---|
| Epidural Analgesia | Active comparator | Procedure: Epidural AnalgesiaThe placement of the thoracic epidural catheter will be located depending on surgical incision as follows: * Surgery of the upper abdomen: T7-T8. * Surgery of lower abdomen: T8-T9. The epidural catheter placement technique will be determined by the treating anesthesiologist. However, once the epidural space is located and the respective catheter is inserted, the correct location of the catheter should be tested with lidocaine at 2% CE 5 cc and a sensitivity test with temperature should be performed on the target dermatomes. A negative test for an adequate location of the catheter indicates that the procedure should be repeated until the epidural space is correctly located. Once this is achieved, the catheter will be left 4 cm away from the skin. The catheter will be fixed according to the institutional protocol. |
| Lidocaine Infussion | Experimental | Drug: Lidocaine InfusionIntravenous lidocaine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Patient over 18 years.
- Elective major open intra-abdominal surgery:
- Patient classified as ASA (American Association of Anesthesiology) 1, 2 or 3.
Key exclusion criteria (13 listed)
- Pregnant woman
- Patient with contraindication for epidural analgesic techniques:
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 |
|---|---|---|
| Epidural AnalgesiaThe epidural infusion will be as follows: * Isobaric Bupivacaine 0.5% 40 cc * Morphine 4 mg (1 ampoule up to 10 cc and 4 cc of the mixture will be applied) * Saline solution 0.9% 156 cc. * Total Volume: 200 cc. This mixture will be prepared by a nurse outside the research group outside the operating room once indicated. The infusion will be scheduled at 7 cc / hour per continuous infusion set and will be connected to the epidural catheter after its placement. | Procedure or surgery | Epidural Analgesia |
| Lidocaine Infusion2% Lidocaine IV without epinephrine: 1 mg/kg/ hour for up to 24 hours, started immediately after anesthetic induction. | Drug | Lidocaine Infussion |
Primary outcome
Posoperative Pain
Time frame: 24 hours after surgery
Numerical Rating Scale (NRS) for pain. The NRS for pain is a unidimensional measure of pain intensity in adults.The pain NRS is a single 11-point numeric scale. An 11-point numeric scale (NRS 11) with 0 representing one pain extreme (e.g., "no pain") and 10 representing the other pain extreme (e.g., "pain as bad as you can imagine" and "worst pain imaginable").
6 secondary outcomes
Posoperative Pain
Time frame: 2, 6, 12, 48 and 72 hours after surgery
Posoperative opioid use
Time frame: 24 hours after surgery
Hospital Stay
Time frame: From date of randomization until the date day of discharge or date of death from any cause, whichever came first, assessed up to 100 months
Perioperative Satisfaction
Time frame: 24 hours
Toxicity by local anesthetics proportion
Time frame: 24 hours after surgery
Posoperative nausea and vomiting
Time frame: 24 hours after surgey
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 26 Sep 2022.
- Results publication: PubMed 21970126Shipton EA. The transition from acute to chronic post surgical pain. Anaesth Intensive Care. 2011 Sep;39(5):824-36. doi: 10.1177/0310057X1103900506.
- Results publication: PubMed 26184397Kranke P, Jokinen J, Pace NL, Schnabel A, Hollmann MW, Hahnenkamp K, Eberhart LH, Poepping DM, Weibel S. Continuous intravenous perioperative lidocaine infusion for postoperative pain and recovery. Cochrane Database Syst Rev. 2015 Jul 16;(7):CD009642. doi: 10.1002/14651858.CD009642.pub2.
- Results publication: PubMed 19488544Couceiro TC, Valenca MM, Lima LC, de Menezes TC, Raposo MC. Prevalence and influence of gender, age, and type of surgery on postoperative pain. Rev Bras Anestesiol. 2009 May-Jun;59(3):314-20. doi: 10.1590/s0034-70942009000300006. English, Portuguese.
- Results publication: PubMed 27761037Singh PK, Saikia P, Lahakar M. Prevalence of acute post-operative pain in patients in adult age-group undergoing inpatient abdominal surgery and correlation of intensity of pain and satisfaction with analgesic management: A cross-sectional single institute-based study. Indian J Anaesth. 2016 Oct;60(10):737-743. doi: 10.4103/0019-5049.191686.
- Results publication: PubMed 23758753Bouman EA, Theunissen M, Bons SA, van Mook WN, Gramke HF, van Kleef M, Marcus MA. Reduced incidence of chronic postsurgical pain after epidural analgesia for abdominal surgery. Pain Pract. 2014 Feb;14(2):E76-84. doi: 10.1111/papr.12091. Epub 2013 Jun 12.
- Results publicationLi M, Li L, Xu Y, Wang X. Intravenous analgesics for pain management in post- operative patients : a comparative study of their efficacy and adverse effects. 2016;15(August):1799-806.
- Results publication: PubMed 26712976Singh AP, Singh D, Singh Y, Jain G. Postoperative analgesic efficacy of epidural tramadol as adjutant to ropivacaine in adult upper abdominal surgeries. Anesth Essays Res. 2015 Sep-Dec;9(3):369-73. doi: 10.4103/0259-1162.161805.
- Results publication: PubMed 22512766Nworah U. From documentation to the problem: controlling postoperative pain. Nurs Forum. 2012 Apr-Jun;47(2):91-9. doi: 10.1111/j.1744-6198.2012.00262.x.
- Results publication: PubMed 23044681Sun Y, Li T, Wang N, Yun Y, Gan TJ. Perioperative systemic lidocaine for postoperative analgesia and recovery after abdominal surgery: a meta-analysis of randomized controlled trials. Dis Colon Rectum. 2012 Nov;55(11):1183-94. doi: 10.1097/DCR.0b013e318259bcd8.
- Results publication: PubMed 26044546Ventham NT, Kennedy ED, Brady RR, Paterson HM, Speake D, Foo I, Fearon KC. Efficacy of Intravenous Lidocaine for Postoperative Analgesia Following Laparoscopic Surgery: A Meta-Analysis. World J Surg. 2015 Sep;39(9):2220-34. doi: 10.1007/s00268-015-3105-6.
- Results publication: PubMed 21418466Kahokehr A, Sammour T, Soop M, Hill AG. Intraperitoneal local anaesthetic in abdominal surgery - a systematic review. ANZ J Surg. 2011 Apr;81(4):237-45. doi: 10.1111/j.1445-2197.2010.05573.x. Epub 2010 Nov 17.
- Results publication: PubMed 25580086Yu N, Long X, Lujan-Hernandez JR, Succar J, Xin X, Wang X. Transversus abdominis-plane block versus local anesthetic wound infiltration in lower abdominal surgery: a systematic review and meta-analysis of randomized controlled trials. BMC Anesthesiol. 2014 Dec 15;14:121. doi: 10.1186/1471-2253-14-121. eCollection 2014.
- Individual participant dataSharing planned: No
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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.
Fabian Casas, Dr principal investigator
Univeridad de Antioquia's Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Epidural Analgesia and Lidocaine Infusion in people with Pain, Postoperative and Opioid Use, run by Universidad de Antioquia at 1 site in Colombia.
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 11 inclusion and 13 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 26 Sep 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 Colombia. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Posoperative Pain (time frame: 24 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 NCT04017013, which also lists 26 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 26 Sep 2022.