Lower Extremities FractureNCT03051022
Comparison Between Dexamethasone and Morphine as an Adjuvant to Bupivacaine for Post-operative Analgesia
A study testing Dexamethasone 8 mg and Morphine 2 mg in people with Lower Extremities Fracture, run by Universitas Indonesia at 1 site in Indonesia.
Trial summary
The study aimed to compare the effectivity of dexamethasone 8 mg and morphine 2 mg as an adjuvant to epidural bupivacaine 0,125% 12,5mg for post-operative analgesia in lower extremities. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Lower Extremities Fracture
- What is being tested?
- Dexamethasone 8 mg and Morphine 2 mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 May 2016to 31 Mar 2017
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Subjects aged 18-60 years old with American Society of Anesthesiologists (ASA) physical status I-II and body mass index (BMI) 18,5-25 kg/m2 who were planned to undergo lower extremity surgery
- Subjects have been explained about the study, have agreed to enroll and have signed the informed consent form
Who cannot join
- Subjects with history of bupivacaine allergy
- Subjects with history of morphine allergy
- Subjects with history of urine retention
- Subjects with history of gait disturbance or using prosthetic, Subjects with history of peptic ulcer
- Subjects with history of long term use of corticosteroid
- Subjects with contraindications for epidural anesthesia
Show all 10Show fewer
- Subjects rejected to participate in the study.
- Drop out criteria:
- Subjects with epidural anesthesia complications (e.g. shock, anaphylactic reaction, seizures, severe respiratory disturbance)
- Subjects with failed epidural anesthesia.
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Cipto Mangunkusumo Hospital
Central Jakarta, DKI Jakarta, 10430
About this study
Official title: The Comparison Between Dexamethasone and Morphine as an Adjuvant to Epidural Bupivacaine for Post-operative Analgesia in Lower Extremity Surgery
The study aimed to compare the effectivity of dexamethasone 8 mg and morphine 2 mg as an adjuvant to epidural bupivacaine 0,125% 12,5mg for post-operative analgesia in lower extremities.
Read the detailed description
Approval from Ethical Committee of Faculty of Medicine University of Indonesia was acquired prior conducting the study. Subjects were given informed consent before enrolling the study and randomized into two groups. Intravenous (IV) cannula with Ringer Lactate fluid, non-invasive blood pressure monitor, electrocardiogram (ECG) and pulse-oxymetry were set on the subjects in the operation room. Epidural catheter was inserted (4 cm depth inside the epidural space) with 1,5-2 mg IV midazolam and 50 mcg IV fentanyl as premedication. The catheter insertion was confirmed with vacuum aspiration and negative test-dose. General anesthesia induction was done by fentanyl 2 mcg/kg, propofol 2 mg/kg, and atracurium 0,5 mg/kg. Maintenance was done by sevoflurane 2vol%, fentanyl and atracurium. Surgery starts without intraoperative epidural regimen. Surgery duration, blood pressure, heart rate, respiratory rate, oxygen saturation by pulse oximetry (SpO2) were recorded. For post-operative analgesia, subjects received paracetamol 1 gr IV and intermittent epidural analgesia regimen in a 10 cc syringe: Group 1 received Bupivacaine 0,125% 12,5 mg combined with dexamethasone 8 mg plus 0,9% sodium chloride (NaCl) until the volume was 10 cc; Group 2 received Bupivacaine 0,125% 12,5 mg combined with morphine 2 mg plus 0,9% NaCl until the volume was 10 cc. The injection was given by anesthesiology residents without knowing the syringe's content. Patient Controlled Analgesia (PCA) morphine was given in the recovery room. Data recorded were blood pressure, heart rate, respiratory rate, oxygen saturation, visual analog scale, side effects, the time when first additional analgesia was needed by subjects, the opioid requirement within 24 hours post-operation. Data was analyzed using Statistical Package for the Social Sciences (SPSS) software, for numerical data using unpaired T-test or Mann-Whitney-U test, for categorical data using Chi-square or Fisher Exact Test. Data normality was tested by Kolmogorov-Smirnov test. Significant value is p<0.05.
- Conditions
- Lower Extremities Fracture
- Being tested
- Dexamethasone 8 mg, Morphine 2 mg
- Keywords
- Bupivacaine, adjuvant, regional anesthesia, dexamethasone, morphine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexamethasone 8 mgDrug
Also called 0.9 % sodium chloride, 12.5 mg of 0.125% bupivacaine
Dexamethasone 8 mg was given via epidural catheter as an adjuvant to 12.5 mg of 0.125% bupivacaine in 10 cc syringe and added with 0.9% sodium chloride until the volume was 10 cc.
Morphine 2 mgDrug
Also called 0.9% sodium chloride, 12.5 mg of 0.125% bupivacaine
Morphine 2 mg was given via epidural catheter as an adjuvant to 12.5 mg of 0.125% bupivacaine in 10 cc syringe and added with 0.9% sodium chloride until the volume was 10 cc.
| Study group | Role | What they receive |
|---|---|---|
| Dexamethasone 8 mg | Active comparator | Bupivacaine 0,125% 12,5 mg combined with dexamethasone 8 mg plus NaCl 0,9% until the volume was 10 cc, prepared in a 10 cc syringe. Receives: Drug: Dexamethasone 8 mg |
| Morphine 2 mg | Active comparator | Bupivacaine 0,125% 12,5 mg combined with morphine 2 mg plus NaCl 0,9% until the volume was 10 cc, prepared in a 10 cc syringe. Receives: Drug: Morphine 2 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
The degree of pain at 24-hours post-operative
The degree of pain was measured using Visual Analog Scale (VAS)
Measured: 24 hours post-operative
The time for first requested post-operative additional analgesia
How long (in minutes) until the subject requested for an additional analgesics after surgery.
Measured: 24 hours post-operative
The opioid requirement with the first 24-hours post-operative
Patient Controlled Analgesia (PCA) measured the opioid requirement in milligram.
Measured: 24-hours post-operative
Secondary outcomes (1)
Side Effects
Side effects measured were incidences of nausea/vomiting, motoric inhibition, sedation, respiratory depression, hypotension
Measured: 24-hours post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2017
- Study start1 May 2016
- Primary completion30 Nov 2016
- Study completion31 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Lower Extremities FractureStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe 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
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. dr. Aida Rosita Tantri SpAn-KA, Universitas Indonesia
- Investigators
- Aida R Tantri, PhD, Principal investigator, Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03051022
- Sponsor's protocol ID
- IndonesiaUAnes008
- Status last verified
- Aug 2017
- First submitted
- 5 Feb 2017
- Last updated
- 18 Aug 2017
- Results posted
- No
- Individual data sharing
- Undecided
Publications
Pakzad H, Roffey DM, Knight H, Dagenais S, Yelle JD, Wai EK. Delay in operative stabilization of spine fractures in multitrauma patients without neurologic injuries: effects on outcomes. Can J Surg. 2011 Aug;54(4):270-6. doi: 10.1503/cjs.008810.
PubMed 21651838Nicola R. Early Total Care versus Damage Control: Current Concepts in the Orthopedic Care of Polytrauma Patients. ISRN Orthop. 2013 Mar 21;2013:329452. doi: 10.1155/2013/329452. eCollection 2013.
PubMed 24959356Xing D, Chen Y, Ma JX, Song DH, Wang J, Yang Y, Feng R, Lu J, Ma XL. A methodological systematic review of early versus late stabilization of thoracolumbar spine fractures. Eur Spine J. 2013 Oct;22(10):2157-66. doi: 10.1007/s00586-012-2624-1. Epub 2012 Dec 22.
PubMed 23263169Ramsay MA. Acute postoperative pain management. Proc (Bayl Univ Med Cent). 2000 Jul;13(3):244-7. doi: 10.1080/08998280.2000.11927683. No abstract available.
PubMed 16389390Voscopoulos C, Lema M. When does acute pain become chronic? Br J Anaesth. 2010 Dec;105 Suppl 1:i69-85. doi: 10.1093/bja/aeq323.
PubMed 21148657Garimella V, Cellini C. Postoperative pain control. Clin Colon Rectal Surg. 2013 Sep;26(3):191-6. doi: 10.1055/s-0033-1351138.
PubMed 24436674Moraca RJ, Sheldon DG, Thirlby RC. The role of epidural anesthesia and analgesia in surgical practice. Ann Surg. 2003 Nov;238(5):663-73. doi: 10.1097/01.sla.0000094300.36689.ad.
PubMed 14578727Becker DE, Reed KL. Essentials of local anesthetic pharmacology. Anesth Prog. 2006 Fall;53(3):98-108; quiz 109-10. doi: 10.2344/0003-3006(2006)53[98:EOLAP]2.0.CO;2.
PubMed 17175824Becker DE, Reed KL. Local anesthetics: review of pharmacological considerations. Anesth Prog. 2012 Summer;59(2):90-101; quiz 102-3. doi: 10.2344/0003-3006-59.2.90.
PubMed 22822998Mercanoglu E, Alanoglu Z, Ekmekci P, Demiralp S, Alkis N. Comparison of intravenous morphine, epidural morphine with/ without bupivacaine or ropivacaine in post-thoracotomy pain management with patient controlled analgesia technique. Braz J Anesthesiol. 2013 Mar-Apr;63(2):213-9. doi: 10.1016/S0034-7094(13)70218-6.
PubMed 23601264Nordquist D, Halaszynski TM. Perioperative multimodal anesthesia using regional techniques in the aging surgical patient. Pain Res Treat. 2014;2014:902174. doi: 10.1155/2014/902174. Epub 2014 Jan 20.
PubMed 24579048Tomar GS, Godwin RB, Gaur N, Sethi A, Narang N, Kachhwaha V, Kriplani TC, Tiwari A. A double-blind study on analgesic effects of fentanyl combined with bupivacaine for extradural labor analgesia. Anesth Essays Res. 2011 Jul-Dec;5(2):147-52. doi: 10.4103/0259-1162.94754.
PubMed 25885378George RB, Allen TK, Habib AS. Intermittent epidural bolus compared with continuous epidural infusions for labor analgesia: a systematic review and meta-analysis. Anesth Analg. 2013 Jan;116(1):133-44. doi: 10.1213/ANE.0b013e3182713b26. Epub 2012 Dec 7.
PubMed 23223119Gan TJ, Meyer T, Apfel CC, Chung F, Davis PJ, Eubanks S, Kovac A, Philip BK, Sessler DI, Temo J, Tramer MR, Watcha M; Department of Anesthesiology, Duke University Medical Center. Consensus guidelines for managing postoperative nausea and vomiting. Anesth Analg. 2003 Jul;97(1):62-71, table of contents. doi: 10.1213/01.ane.0000068580.00245.95.
PubMed 12818945Hefni AF, Mahmoud MS, Al Alim AA. Epidural dexamethasone for post-operative analgesia in patients undergoing abdominal hysterectomy: A dose ranging and safety evaluation study. Saudi J Anaesth. 2014 Jul;8(3):323-7. doi: 10.4103/1658-354X.136420.
PubMed 25191180
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Comparison Between Dexamethasone and Morphine as an Adjuvant to Epidural Bupivacaine for Post-operative Analgesia in Lower Extremity Surgery
- ClinicalTrials.gov ID
- NCT03051022
- Acronym / sponsor ID
- IndonesiaUAnes008
- Conditions
- Lower Extremities Fracture
- Keywords
- Bupivacaine, adjuvant, regional anesthesia, dexamethasone, morphine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 1 May 2016 (actual)
- Primary completion
- 30 Nov 2016 (actual)
- Study completion
- 31 Mar 2017 (actual)
- First posted
- 13 Feb 2017 (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 study aimed to compare the effectivity of dexamethasone 8 mg and morphine 2 mg as an adjuvant to epidural bupivacaine 0,125% 12,5mg for post-operative analgesia in lower extremities.
Detailed description
Approval from Ethical Committee of Faculty of Medicine University of Indonesia was acquired prior conducting the study. Subjects were given informed consent before enrolling the study and randomized into two groups. Intravenous (IV) cannula with Ringer Lactate fluid, non-invasive blood pressure monitor, electrocardiogram (ECG) and pulse-oxymetry were set on the subjects in the operation room. Epidural catheter was inserted (4 cm depth inside the epidural space) with 1,5-2 mg IV midazolam and 50 mcg IV fentanyl as premedication. The catheter insertion was confirmed with vacuum aspiration and negative test-dose. General anesthesia induction was done by fentanyl 2 mcg/kg, propofol 2 mg/kg, and atracurium 0,5 mg/kg. Maintenance was done by sevoflurane 2vol%, fentanyl and atracurium. Surgery starts without intraoperative epidural regimen. Surgery duration, blood pressure, heart rate, respiratory rate, oxygen saturation by pulse oximetry (SpO2) were recorded. For post-operative analgesia, subjects received paracetamol 1 gr IV and intermittent epidural analgesia regimen in a 10 cc syringe: Group 1 received Bupivacaine 0,125% 12,5 mg combined with dexamethasone 8 mg plus 0,9% sodium chloride (NaCl) until the volume was 10 cc; Group 2 received Bupivacaine 0,125% 12,5 mg combined with morphine 2 mg plus 0,9% NaCl until the volume was 10 cc. The injection was given by anesthesiology residents without knowing the syringe's content. Patient Controlled Analgesia (PCA) morphine was given in the recovery room. Data recorded were blood pressure, heart rate, respiratory rate, oxygen saturation, visual analog scale, side effects, the time when first additional analgesia was needed by subjects, the opioid requirement within 24 hours post-operation. Data was analyzed using Statistical Package for the Social Sciences (SPSS) software, for numerical data using unpaired T-test or Mann-Whitney-U test, for categorical data using Chi-square or Fisher Exact Test. Data normality was tested by Kolmogorov-Smirnov test. Significant value is p<0.05.
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 |
|---|---|---|
| Dexamethasone 8 mg | Active comparator | Drug: Dexamethasone 8 mgBupivacaine 0,125% 12,5 mg combined with dexamethasone 8 mg plus NaCl 0,9% until the volume was 10 cc, prepared in a 10 cc syringe. |
| Morphine 2 mg | Active comparator | Drug: Morphine 2 mgBupivacaine 0,125% 12,5 mg combined with morphine 2 mg plus NaCl 0,9% until the volume was 10 cc, prepared in a 10 cc syringe. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Subjects aged 18-60 years old with American Society of Anesthesiologists (ASA) physical status I-II and body mass index (BMI) 18,5-25 kg/m2 who were planned to undergo lower extremity surgery
- Subjects have been explained about the study, have agreed to enroll and have signed the informed consent form
Key exclusion criteria (10 listed)
- Subjects with history of bupivacaine allergy
- Subjects with history of morphine allergy
- Subjects with history of urine retention
- Subjects with history of gait disturbance or using prosthetic, Subjects with history of peptic ulcer
- Subjects with history of long term use of corticosteroid
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 |
|---|---|---|
| Dexamethasone 8 mgAlso: 0.9 % sodium chloride, 12.5 mg of 0.125% bupivacaineDexamethasone 8 mg was given via epidural catheter as an adjuvant to 12.5 mg of 0.125% bupivacaine in 10 cc syringe and added with 0.9% sodium chloride until the volume was 10 cc. | Drug | Dexamethasone 8 mg |
| Morphine 2 mgAlso: 0.9% sodium chloride, 12.5 mg of 0.125% bupivacaineMorphine 2 mg was given via epidural catheter as an adjuvant to 12.5 mg of 0.125% bupivacaine in 10 cc syringe and added with 0.9% sodium chloride until the volume was 10 cc. | Drug | Morphine 2 mg |
Primary outcome
The degree of pain at 24-hours post-operative
Time frame: 24 hours post-operative
The degree of pain was measured using Visual Analog Scale (VAS)
The time for first requested post-operative additional analgesia
Time frame: 24 hours post-operative
How long (in minutes) until the subject requested for an additional analgesics after surgery.
The opioid requirement with the first 24-hours post-operative
Time frame: 24-hours post-operative
Patient Controlled Analgesia (PCA) measured the opioid requirement in milligram.
1 secondary outcome
Side Effects
Time frame: 24-hours post-operative
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 18 Aug 2017.
- Background: PubMed 21651838Pakzad H, Roffey DM, Knight H, Dagenais S, Yelle JD, Wai EK. Delay in operative stabilization of spine fractures in multitrauma patients without neurologic injuries: effects on outcomes. Can J Surg. 2011 Aug;54(4):270-6. doi: 10.1503/cjs.008810.
- Background: PubMed 24959356Nicola R. Early Total Care versus Damage Control: Current Concepts in the Orthopedic Care of Polytrauma Patients. ISRN Orthop. 2013 Mar 21;2013:329452. doi: 10.1155/2013/329452. eCollection 2013.
- Background: PubMed 23263169Xing D, Chen Y, Ma JX, Song DH, Wang J, Yang Y, Feng R, Lu J, Ma XL. A methodological systematic review of early versus late stabilization of thoracolumbar spine fractures. Eur Spine J. 2013 Oct;22(10):2157-66. doi: 10.1007/s00586-012-2624-1. Epub 2012 Dec 22.
- Background: PubMed 16389390Ramsay MA. Acute postoperative pain management. Proc (Bayl Univ Med Cent). 2000 Jul;13(3):244-7. doi: 10.1080/08998280.2000.11927683. No abstract available.
- Background: PubMed 21148657Voscopoulos C, Lema M. When does acute pain become chronic? Br J Anaesth. 2010 Dec;105 Suppl 1:i69-85. doi: 10.1093/bja/aeq323.
- Background: PubMed 24436674Garimella V, Cellini C. Postoperative pain control. Clin Colon Rectal Surg. 2013 Sep;26(3):191-6. doi: 10.1055/s-0033-1351138.
- Background: PubMed 14578727Moraca RJ, Sheldon DG, Thirlby RC. The role of epidural anesthesia and analgesia in surgical practice. Ann Surg. 2003 Nov;238(5):663-73. doi: 10.1097/01.sla.0000094300.36689.ad.
- Background: PubMed 17175824Becker DE, Reed KL. Essentials of local anesthetic pharmacology. Anesth Prog. 2006 Fall;53(3):98-108; quiz 109-10. doi: 10.2344/0003-3006(2006)53[98:EOLAP]2.0.CO;2.
- Background: PubMed 22822998Becker DE, Reed KL. Local anesthetics: review of pharmacological considerations. Anesth Prog. 2012 Summer;59(2):90-101; quiz 102-3. doi: 10.2344/0003-3006-59.2.90.
- Background: PubMed 23601264Mercanoglu E, Alanoglu Z, Ekmekci P, Demiralp S, Alkis N. Comparison of intravenous morphine, epidural morphine with/ without bupivacaine or ropivacaine in post-thoracotomy pain management with patient controlled analgesia technique. Braz J Anesthesiol. 2013 Mar-Apr;63(2):213-9. doi: 10.1016/S0034-7094(13)70218-6.
- Background: PubMed 24579048Nordquist D, Halaszynski TM. Perioperative multimodal anesthesia using regional techniques in the aging surgical patient. Pain Res Treat. 2014;2014:902174. doi: 10.1155/2014/902174. Epub 2014 Jan 20.
- Background: PubMed 25885378Tomar GS, Godwin RB, Gaur N, Sethi A, Narang N, Kachhwaha V, Kriplani TC, Tiwari A. A double-blind study on analgesic effects of fentanyl combined with bupivacaine for extradural labor analgesia. Anesth Essays Res. 2011 Jul-Dec;5(2):147-52. doi: 10.4103/0259-1162.94754.
- Individual participant dataSharing planned: Undecided
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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.
Aida R Tantri, PhD principal investigator
Universitas Indonesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dexamethasone 8 mg and Morphine 2 mg in people with Lower Extremities Fracture, run by Universitas Indonesia at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 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 18 Aug 2017. 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 Indonesia. 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?
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?
The degree of pain at 24-hours post-operative (time frame: 24 hours post-operative). The study lists 3 primary outcomes in all. 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 NCT03051022, which also lists 16 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 18 Aug 2017.