Postoperative PainNCT04052867
Intravenous Lignocaine Infusion in Laparoscopic Donor Nephrectomy
A study testing Lignocaine and Normal saline in people with Postoperative Pain and Renal Transplantation, run by University of Malaya at 1 site in Malaysia.
Trial summary
Background: Administration of morphine as boluses or via a patient controlled analgesic device (PCA) has been the standard practice for donors after nephrectomy. However, administration of morphine is far from being ideal analgesic as it does not provide optimal dynamic pain relief after major surgery, consistently… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Postoperative Pain, Renal Transplantation, Morphine Adverse Reaction
- What is being tested?
- Lignocaine and Normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteMalaysia
- Study dates
- 17 Sep 2019to 31 Jul 2021
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- elective laparoscopic donor nephrectomy
Who cannot join
- refuse consent
- allergic to local anaesthetics or opioids,
- on long term analgesics for chronic pain,
- have impaired liver function
- has history of arrhythmias
Trial locations and contacts
1 site in 1 country.
Sook Hui Chaw, MD contact
Malaysia1 site, 1 recruiting
- Recruiting
University Malaya
Kuala Lumpur, Kuala Lumpur, 50603
University Malaya
About this study
Official title: Intravenous Lignocaine Infusion as a Multimodal Analgesic Approach in Laparoscopic Donor Nephrectomy
Background:
Administration of morphine as boluses or via a patient controlled analgesic device (PCA) has been the standard practice for donors after nephrectomy.
Read more
However, administration of morphine is far from being ideal analgesic as it does not provide optimal dynamic pain relief after major surgery, consistently demonstrate little effect on surgical stress response and organ dysfunction with high incidences of postoperative nausea/vomiting, respiratory depression and sedation. Several studies demonstrated perioperative intravenous lignocaine infusion can improve post-operative pain scores and morphine consumption in abdominal surgery.
The aim of this study is to identify the effectiveness of intra-operative lignocaine infusion in lowering postoperative pain and reduce postoperative morphine consumption in patients who undergo laparoscopic donor nephrectomy.
Read the detailed description
Hypothesis:
Patients who receive intravenous lignocaine infusion as a multimodal analgesic technique will require less morphine postoperatively with lower pain scores on the visual analogue scale (VAS).
Methodology The main clinical study is a randomized double blinded control trial that will start after ethics approval from UMREC and registration at Clinical Trial Registry. All adults undergoing elective laparoscopic donor nephrectomy will be recruited in this double-blinded randomised controlled trial. After obtaining their informed consent, patients will be shown the visual analogue score (VAS) as the post-operative pain assessment and their baseline pain scores obtained. Instructions are also given for patient controlled analgesic (PCA) device using morphine for post-operative pain control.
Randomisation and blinding:
There will be two groups - lignocaine and control. Randomization will be based on a computer generated random number and sealed in opaque envelopes. On the day of surgery, one of the investigators who must not be involved in the care of the case, opens the envelope to follow the allocated group number and prepare either lignocaine or normal saline solutions. Both syringes are labelled with the assigned number only and handed to the attending anaesthesiologist in charge of the surgery. The patient as well as the attending anaesthetic team is blinded to the allocated group. Similarly, post-operative observers who collect the required data will be blinded.
Sample size:
Sample size is calculated based on a pilot study. A power analysis revealed that 15 patients in each group is required to detect a difference of 6 mg between the morphine consumption of the two groups for a power of 80% and and a level of statistical significance at 5%. To provide adequate power for additional analysis, we planned to enrol 20 patients in each group with further allowance for 10% drop out for the per protocol analysis.
Conduct of anaesthesia All patients are administered general anaesthesia with 2mcg/kg of fentanyl, 2-3mg/kg of propofol and 0.6mg/kg of rocuronium for induction, intubated and maintained with desflurane in oxygen-air mixture to MAC of 1.0-1.3. Haemodynamic parameters are measured with standard monitoring and kept within 10% of baseline. All management of ventilation, temperature control and fluids will be done according to institutional protocol for renal transplant.
Study drug protocol 2 groups - Control OR Lignocaine group. Lignocaine group: After induction, securing airway and intravenous lines, patients are turned lateral into the lateral decubitus nephrectomy position. Once the correct position is achieved and haemodynamic status is stable, a slow bolus of 1.5mg/kg of 1% lignocaine is given over 15 min before the start of surgery, followed by an infusion at 1.5mg/kg/hr for the lignocaine group. If the patient's BMI is >30, the ideal body weight (IBW) is used to calculate the bolus and infusion dose at a maximal rate of 100mg/hr for a wide margin of safety.
Control group: An equivalent volume of normal saline is given.
Multimodal analgesia All patients will receive
- 0.05-0.1 mg/kg of intravenous morphine intra-operatively.
- One gram of intravenous paracetamol and 40mg of intravenous parecoxib (30min before end of surgery) unless contraindicated.
- Anti-emetics - dexamethasone 4mg and IV ondansetron 4mg
- 20-30 mls of plain bupivacaine 0.5% (not exceeding 2mg/kg) will be infiltrated subcutaneously
In the recovery room, the PCA device is set to deliver 1mg bolus of morphine without a baseline infusion, lockout period of 5 min and maximum of 30mg morphine in 4 hours.
- The time to first PCA use is noted.
- Pain scores using VAS will be recorded at 30 min, 1 hour, 6 hours, 12 hours and 24 hours post-operatively.
- Other symptoms such as sedation, nausea, vomiting, light headedness, perioral numbness, and pruritus are reported if it occurs during the first postoperative day.
In the ward, oral paracetamol 1g 6hourly and oral celecoxib 200mg 12hourly will be prescribed for administration in the ward. Total IV morphine consumption at the end of the 24 hours are recorded.
Demographic data, medical history, physical examination, pre- and postoperative laboratory results for renal function (eGFR and creatinine clearance) will be collected prospectively. All post-operative pain scores/ satisfaction scores/ complications will be reviewed and recorded by a blinded observer.
4 blood samples will be taken from every recruited patient - baseline pre-op, before nephrectomy, after nephrectomy and 24 hours post-op.
- Being tested
- Lignocaine, Normal saline
- Keywords
- Intravenous lignocaine, Multimodal anagesic approach, Postoperative Pain, living related renal transplantation, Morphine
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LignocaineDrug
Also called Intravenous lignocaine
Slow bolus of lignocaine is given over 15 min before the start of surgery, followed by infusion of lignocaine
Normal salineDrug
An equivalent volume of normal saline is given
| Study group | Role | What they receive |
|---|---|---|
| Lignocaine group | Experimental | 20 patients undergoing elective laparoscopic donor nephrectomy will be given lignocaine infusion as part of the perioperative pain management. Receives: Drug: Lignocaine |
| Control group | Active comparator | 20 patients undergoing elective laparoscopic donor nephrectomy will be receiving an equivalent volume of normal saline. Receives: Drug: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative morphine requirement
Morphine usage post-operatively
Measured: 24 hours postoperatively
Secondary outcomes (1)
Level of systemic lignocaine
Serial venous blood are taken at 4 different intervals
Measured: before lignocaine infusion, after lignocaine infusion just before nephrectomy, half hour after nephrectomy, within 24 post operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2019
- Study start17 Sep 2019
- Primary completion15 Jul 2021 (estimated)
- Study completion31 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by University of MalayaThe sponsor's other registered studies.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Malaya
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Loh Pui San, University of Malaya
- Investigators
- Pui San Loh, MBBS, MMed, Principal investigator, University Malaya, Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04052867
- Sponsor's protocol ID
- U1111-1237-9350
- Status last verified
- Apr 2020
- First submitted
- 8 Aug 2019
- Last updated
- 30 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mathuram Thiyagarajan U, Bagul A, Nicholson ML. Pain management in laparoscopic donor nephrectomy: a review. Pain Res Treat. 2012;2012:201852. doi: 10.1155/2012/201852. Epub 2012 Oct 23.
PubMed 23150820Waller JR, Hiley AL, Mullin EJ, Veitch PS, Nicholson ML. Living kidney donation: a comparison of laparoscopic and conventional open operations. Postgrad Med J. 2002 Mar;78(917):153-7. doi: 10.1136/pmj.78.917.153.
PubMed 11884697Gerbershagen HJ, Dagtekin O, Rothe T, Heidenreich A, Gerbershagen K, Sabatowski R, Petzke F, Ozgur E. Risk factors for acute and chronic postoperative pain in patients with benign and malignant renal disease after nephrectomy. Eur J Pain. 2009 Sep;13(8):853-60. doi: 10.1016/j.ejpain.2008.10.001. Epub 2008 Nov 14.
PubMed 19010073Dolin SJ, Cashman JN, Bland JM. Effectiveness of acute postoperative pain management: I. Evidence from published data. Br J Anaesth. 2002 Sep;89(3):409-23.
PubMed 12402719Weibel 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 27199310Sun 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 23044681Kranke 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 26184397Vigneault 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 21061107McCarthy 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 20518581Kaba A, Laurent SR, Detroz BJ, Sessler DI, Durieux ME, Lamy ML, Joris JL. Intravenous lidocaine infusion facilitates acute rehabilitation after laparoscopic colectomy. Anesthesiology. 2007 Jan;106(1):11-8; discussion 5-6. doi: 10.1097/00000542-200701000-00007.
PubMed 17197840Dunn LK, Durieux ME. Perioperative Use of Intravenous Lidocaine. Anesthesiology. 2017 Apr;126(4):729-737. doi: 10.1097/ALN.0000000000001527. No abstract available.
PubMed 28114177
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravenous Lignocaine Infusion as a Multimodal Analgesic Approach in Laparoscopic Donor Nephrectomy
- ClinicalTrials.gov ID
- NCT04052867
- Acronym / sponsor ID
- U1111-1237-9350
- Keywords
- Intravenous lignocaine, Multimodal anagesic approach, Postoperative Pain, living related renal transplantation, Morphine
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of MalayaUniversity, hospital or other
- Study start
- 17 Sep 2019 (actual)
- Primary completion
- 15 Jul 2021 (estimated)
- Study completion
- 31 Jul 2021 (estimated)
- First posted
- 12 Aug 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.
Background:
Administration of morphine as boluses or via a patient controlled analgesic device (PCA) has been the standard practice for donors after nephrectomy.
However, administration of morphine is far from being ideal analgesic as it does not provide optimal dynamic pain relief after major surgery, consistently demonstrate little effect on surgical stress response and organ dysfunction with high incidences of postoperative nausea/vomiting, respiratory depression and sedation. Several studies demonstrated perioperative intravenous lignocaine infusion can improve post-operative pain scores and morphine consumption in abdominal surgery.
The aim of this study is to identify the effectiveness of intra-operative lignocaine infusion in lowering postoperative pain and reduce postoperative morphine consumption in patients who undergo laparoscopic donor nephrectomy.
Detailed description
Hypothesis:
Patients who receive intravenous lignocaine infusion as a multimodal analgesic technique will require less morphine postoperatively with lower pain scores on the visual analogue scale (VAS).
Methodology The main clinical study is a randomized double blinded control trial that will start after ethics approval from UMREC and registration at Clinical Trial Registry. All adults undergoing elective laparoscopic donor nephrectomy will be recruited in this double-blinded randomised controlled trial. After obtaining their informed consent, patients will be shown the visual analogue score (VAS) as the post-operative pain assessment and their baseline pain scores obtained. Instructions are also given for patient controlled analgesic (PCA) device using morphine for post-operative pain control.
Randomisation and blinding:
There will be two groups - lignocaine and control. Randomization will be based on a computer generated random number and sealed in opaque envelopes. On the day of surgery, one of the investigators who must not be involved in the care of the case, opens the envelope to follow the allocated group number and prepare either lignocaine or normal saline solutions. Both syringes are labelled with the assigned number only and handed to the attending anaesthesiologist in charge of the surgery. The patient as well as the attending anaesthetic team is blinded to the allocated group. Similarly, post-operative observers who collect the required data will be blinded.
Sample size:
Sample size is calculated based on a pilot study. A power analysis revealed that 15 patients in each group is required to detect a difference of 6 mg between the morphine consumption of the two groups for a power of 80% and and a level of statistical significance at 5%. To provide adequate power for additional analysis, we planned to enrol 20 patients in each group with further allowance for 10% drop out for the per protocol analysis.
Conduct of anaesthesia All patients are administered general anaesthesia with 2mcg/kg of fentanyl, 2-3mg/kg of propofol and 0.6mg/kg of rocuronium for induction, intubated and maintained with desflurane in oxygen-air mixture to MAC of 1.0-1.3. Haemodynamic parameters are measured with standard monitoring and kept within 10% of baseline. All management of ventilation, temperature control and fluids will be done according to institutional protocol for renal transplant.
Study drug protocol 2 groups - Control OR Lignocaine group. Lignocaine group: After induction, securing airway and intravenous lines, patients are turned lateral into the lateral decubitus nephrectomy position. Once the correct position is achieved and haemodynamic status is stable, a slow bolus of 1.5mg/kg of 1% lignocaine is given over 15 min before the start of surgery, followed by an infusion at 1.5mg/kg/hr for the lignocaine group. If the patient's BMI is >30, the ideal body weight (IBW) is used to calculate the bolus and infusion dose at a maximal rate of 100mg/hr for a wide margin of safety.
Control group: An equivalent volume of normal saline is given.
Multimodal analgesia All patients will receive
- 0.05-0.1 mg/kg of intravenous morphine intra-operatively.
- One gram of intravenous paracetamol and 40mg of intravenous parecoxib (30min before end of surgery) unless contraindicated.
- Anti-emetics - dexamethasone 4mg and IV ondansetron 4mg
- 20-30 mls of plain bupivacaine 0.5% (not exceeding 2mg/kg) will be infiltrated subcutaneously
In the recovery room, the PCA device is set to deliver 1mg bolus of morphine without a baseline infusion, lockout period of 5 min and maximum of 30mg morphine in 4 hours.
- The time to first PCA use is noted.
- Pain scores using VAS will be recorded at 30 min, 1 hour, 6 hours, 12 hours and 24 hours post-operatively.
- Other symptoms such as sedation, nausea, vomiting, light headedness, perioral numbness, and pruritus are reported if it occurs during the first postoperative day.
In the ward, oral paracetamol 1g 6hourly and oral celecoxib 200mg 12hourly will be prescribed for administration in the ward. Total IV morphine consumption at the end of the 24 hours are recorded.
Demographic data, medical history, physical examination, pre- and postoperative laboratory results for renal function (eGFR and creatinine clearance) will be collected prospectively. All post-operative pain scores/ satisfaction scores/ complications will be reviewed and recorded by a blinded observer.
4 blood samples will be taken from every recruited patient - baseline pre-op, before nephrectomy, after nephrectomy and 24 hours post-op.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lignocaine group | Experimental | Drug: Lignocaine20 patients undergoing elective laparoscopic donor nephrectomy will be given lignocaine infusion as part of the perioperative pain management. |
| Control group | Active comparator | Drug: Normal saline20 patients undergoing elective laparoscopic donor nephrectomy will be receiving an equivalent volume of normal saline. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- elective laparoscopic donor nephrectomy
Key exclusion criteria (5 listed)
- refuse consent
- allergic to local anaesthetics or opioids,
- on long term analgesics for chronic pain,
- have impaired liver function
- has history of arrhythmias
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 |
|---|---|---|
| LignocaineAlso: Intravenous lignocaineSlow bolus of lignocaine is given over 15 min before the start of surgery, followed by infusion of lignocaine | Drug | Lignocaine group |
| Normal salineAn equivalent volume of normal saline is given | Drug | Control group |
Primary outcome
Postoperative morphine requirement
Time frame: 24 hours postoperatively
Morphine usage post-operatively
1 secondary outcome
Level of systemic lignocaine
Time frame: before lignocaine infusion, after lignocaine infusion just before nephrectomy, half hour after nephrectomy, within 24 post operatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2020.
- Background: PubMed 23150820Mathuram Thiyagarajan U, Bagul A, Nicholson ML. Pain management in laparoscopic donor nephrectomy: a review. Pain Res Treat. 2012;2012:201852. doi: 10.1155/2012/201852. Epub 2012 Oct 23.
- Background: PubMed 11884697Waller JR, Hiley AL, Mullin EJ, Veitch PS, Nicholson ML. Living kidney donation: a comparison of laparoscopic and conventional open operations. Postgrad Med J. 2002 Mar;78(917):153-7. doi: 10.1136/pmj.78.917.153.
- Background: PubMed 19010073Gerbershagen HJ, Dagtekin O, Rothe T, Heidenreich A, Gerbershagen K, Sabatowski R, Petzke F, Ozgur E. Risk factors for acute and chronic postoperative pain in patients with benign and malignant renal disease after nephrectomy. Eur J Pain. 2009 Sep;13(8):853-60. doi: 10.1016/j.ejpain.2008.10.001. Epub 2008 Nov 14.
- Background: PubMed 12402719Dolin SJ, Cashman JN, Bland JM. Effectiveness of acute postoperative pain management: I. Evidence from published data. Br J Anaesth. 2002 Sep;89(3):409-23.
- 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 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.
- Background: 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.
- 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 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 17197840Kaba A, Laurent SR, Detroz BJ, Sessler DI, Durieux ME, Lamy ML, Joris JL. Intravenous lidocaine infusion facilitates acute rehabilitation after laparoscopic colectomy. Anesthesiology. 2007 Jan;106(1):11-8; discussion 5-6. doi: 10.1097/00000542-200701000-00007.
- Background: PubMed 28114177Dunn LK, Durieux ME. Perioperative Use of Intravenous Lidocaine. Anesthesiology. 2017 Apr;126(4):729-737. doi: 10.1097/ALN.0000000000001527. No abstract available.
- 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.
Sook Hui Chaw, MD contact
Pui San Loh, MBBS, MMed principal investigator
University Malaya, Malaysia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lignocaine and Normal saline in people with Postoperative Pain and Renal Transplantation, run by University of Malaya at 1 site in Malaysia.
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 1 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: status not confirmed, as of the sponsor's last update on 30 Apr 2020. 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 Malaysia. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pui San Loh, MBBS, MMed (012-2268285, lohps@ummc.edu.my), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative morphine requirement (time frame: 24 hours postoperatively). 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 NCT04052867, which also lists 11 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 30 Apr 2020.