Pain, PostoperativePhase 4NCT04624360
The Effect of IV Dexamethasone on the Duration of Analgesia of Spinal Anaesthesia for C-Sections at a Jamaican Hospital
A Phase 4 study testing Dexamethasone in people with Pain, Postoperative, run by The University of The West Indies at 1 site in Jamaica.
Trial summary
Dexamethasone is one of many adjuncts tested to prolong the duration of spinal anesthesia and its analgesic effect. The intent of this, a single-site, double-blinded, randomized controlled trial, is to determine if a single intravenous (IV) 8 mg dose of Dexamethasone given after clamping of the umbilical cord at… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- Dexamethasone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteJamaica
- Study dates
- 27 Jun 2020to Dec 2020
- 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 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients at Victoria Jubilee Hospital in Jamaica, scheduled for non-emergent LSCS under spinal anesthesia
- Age: 18 to 45 years
- Gestational Age: 37 weeks or more
- American Society of Anesthesiologists physical status class II
- Singleton fetus
Who cannot join
- Emergent Indication for caesarean section including, but not limited to:
- Fetal distress
- Cord prolapse
- Eclampsia
- Severe pre-eclampsia
- Placental abruption
Show all 18Show fewer
- Placenta praevia
- Multiple Gestation
- Allergy to glucocorticoids/opioids/Diclofenac Na/ local anesthetics
- Contra-indication to Spinal Anesthesia
- Gestational Diabetes or Pre-gestational Diabetes
- Asthma
- Other uncontrolled comorbidities (such as cardiac, respiratory, renal, inflammatory, endocrine disease)
- Chronic steroid use
- history of Peptic Ulcer Disease or Glaucoma
- history of chronic pain
- Illicit drug users (including marijuana)
- Any patient who requires general anesthesia secondary to failure of spinal anesthesia will also be excluded
Trial locations and contacts
1 site in 1 country.
Jamaica1 site, 1 recruiting
- Recruiting
Victoria Jubilee Hospital
Kingston, Non-US/Canada, 6
Christine Stephen, MB;BS, DM, 8769220210, rmnesbeth@gmail.com
About this study
Official title: Randomised Controlled Trial Comparing the Effect of Intravenous Dexamethasone vs. Placebo on the Duration of Analgesia of Spinal Anaesthesia for Caesarean Sections at the Victoria Jubilee Hospital in Jamaica
Dexamethasone is one of many adjuncts tested to prolong the duration of spinal anesthesia and its analgesic effect. The intent of this, a single-site, double-blinded, randomized controlled trial, is to determine if a single intravenous (IV) 8 mg dose of Dexamethasone given after clamping of the umbilical cord at Caesarean section will prolong the duration of analgesia provided by spinal anesthesia when compared to placebo. This has the power to determine if the findings in previous studies hold true in the population of women who undergo C-sections at the Victoria Jubilee Hospital. This method does not require expert skill and equipment, as such, it can be easily implemented, with no major adverse effects in the population described and provide an effective option for multimodal analgesia.
Read the detailed description
This study is being conducted in accordance with the Good Clinical Practice guidelines as enunciated in the international Conference on Harmonization (ICP/GCP) of 2016 and the Declaration of Helsinki, 2013.
Sample Size:
The sample size calculated based on a study done by Shahraki et al who studied the efficacy of intravenous Dexamethasone in prolonging the duration of Spinal Anesthesia in elective Caesarean Section in an Indian population (36).
The following values were used for the calculation of the sample size: the required value of α was 5%, β was 10%, a clinically significant difference in Visual Analogue Scale (VAS) score at 1-hour post-surgery was considered 2 and the expected standard deviation was 2.5 (36). The equation used was:
n = (Zα/2+Zβ)2 *2*σ2 / d2,
where Zα/2 is the critical value of the normal distribution at α/2 (α is 0.05), Zβ is the critical value of the normal distribution at β of 0.10. σ2 is the population variance (2.52), and d is the difference to be detected (2). The calculated sample size is 14 patients in each group. In order allow for a potential loss of data up to 10% the target sample size required would be 16 in each group.
Assumptions:
- The population size is limited by:
- patient's age,
- gestational age,
- the type of birth - only Caesarian births,
- use of a single hospital - VJH
- the duration of the research of approximately 2 to 3 months.
- As a result of item 1, when the Finite Population model is used to determine the sample size -
S = Z2 * p(p-1) / E2
1 + (Z2 * p(p-1) / E2N)
Other parameters include:
- 95% Confidence level
- Margin of error 5%
- Number of live births at VJH in 2016 estimated at 8140 live births
- Number of Caesarian births same period = 1652
- Percent of Caesarian births (with access to in 2 to 3 months) = 3.6 to 5%
The computed sample size ranges from 53 (2 months) to 72 (3 months) The decision was made to include 30 patients in each group totaling 60 persons for the sample size for this study.
Research assistants received training in the study protocol. Presentations were made to the registration clerks, obstetricians, midwives and other nursing staff to introduce them to the study.
Recruitment The registration clerk informs the patients of the study being carried out from admission to hospital. The ward nurse, upon admitting the patient, determine if they meet the criteria and indicates same to a member of the research team. Written informed consent is obtained by an independent research assistant, once it is confirmed that the patient meets the criteria, to avoid any perception of coercion on the night before or the morning of their procedure. The patient's autonomy is respected and quality medical care will is provided for those who participate in the study as well as those who decline.
Conceptual Definition of Variables Duration of analgesia: the time from intrathecal injection to the time of the first request for analgesia or Visual Analogue Pain Scale score > 4.
Duration of motor blockade: the time from intrathecal injection to the time when the patient is able to flex their knees with free movement of their feet in any plane.
Data Collection/ Storage The data collected for research is stored in a secured area in the Anesthetic Office at the Kingston Public Hospital with access limited to the research team only. Back-up of the data is stored off-site in a locked room in the Anesthetic Office of the University Hospital of the West Indies. Each patient is assigned a study number, and strict security measures are employed to ensure maximum protection of data and the privacy of the research subjects such as password protection and anonymity of data.
If a participant decides to withdraw from the study, the data collected prior to withdrawal may be used in data analysis and the same anonymity applies. Withdrawal from the study will not affect the participant's access to quality health care.
Source Data Verification This is done by cross-referencing the data entered on the data collection forms with the patients' dockets.
Statistical Analysis The data will be managed and analyzed using Statistical Package for the Social Sciences [SPSS] version 26.0 (2019). Uni-variate, bi-variate and multi-variate analysis of the data will be done. Uni-variate analysis will include means ± standard deviation. Bi-variate analysis will include will include independent/ paired t-tests for quantitative data; Chi square test and Mann-Whitney's U test where applicable. Multi-variate analysis will include regression and other measurements where necessary. A p value of less than 0.05 will be deemed statistically significant.
- Conditions
- Pain, Postoperative
- Being tested
- Dexamethasone, Placebo
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamethasoneDrug
Also called Study Drug A
Intravenous of Dexamethasone 8 mg post clamping of the umbilical cord
PlaceboOther
Also called Study Drug B
2cc 0.9% Saline
| Study group | Role | What they receive |
|---|---|---|
| Study Drug A | Experimental | Dexamethasone 8mg intravenous administration stat dose post clamping of the umbilical cord Receives: Drug: Dexamethasone |
| Study Drug B | Placebo comparator | Normal saline 2cc intravenous stat dose administered after clamping of the umbilical cord Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of analgesia
The duration of time from the administration of drugs intrathecally for spinal anesthesia to the first request for analgesia or first time the pain score is greater than 4
Measured: first 4 hours after spinal anesthesia administered
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2020
- Study start27 Jun 2020
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (28)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
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of The West Indies
- Sponsor type
- University, hospital or other
- Collaborators
- National Health Fund of Jamaica
- Responsible party
- Principal investigator, Renee Nesbeth, The University of The West Indies
- Investigators
- Christine Stephen, MB;BS, DM, Principal investigator, University of the West Indies
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04624360
- Sponsor's protocol ID
- VJH Dexa Study
- Status last verified
- Nov 2020
- First submitted
- 9 Nov 2020
- Last updated
- 10 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Joshi GP, Ogunnaike BO. Consequences of inadequate postoperative pain relief and chronic persistent postoperative pain. Anesthesiol Clin North Am. 2005 Mar;23(1):21-36. doi: 10.1016/j.atc.2004.11.013.
PubMed 15763409Carvalho B, Cohen SE, Lipman SS, Fuller A, Mathusamy AD, Macario A. Patient preferences for anesthesia outcomes associated with cesarean delivery. Anesth Analg. 2005 Oct;101(4):1182-1187. doi: 10.1213/01.ane.0000167774.36833.99.
PubMed 16192541Jadon A, Bagai R. Effective pain relief after caesarean section; Are we on the right path or still on the crossroad. Journal of Obstetric Anaesthesia and Critical Care. 2019;9(1):3-6
Eisenach JC, Pan PH, Smiley R, Lavand'homme P, Landau R, Houle TT. Severity of acute pain after childbirth, but not type of delivery, predicts persistent pain and postpartum depression. Pain. 2008 Nov 15;140(1):87-94. doi: 10.1016/j.pain.2008.07.011. Epub 2008 Sep 24.
PubMed 18818022Marian Knight KB, Derek Tuffnell, Hemali Jayakody,Judy Shakespeare RK, Sara Kenyon,, Kurinczuk JJ. MBRRACE-UK: Saving Lives, Improving Mothers' Care - Lessons learned to inform maternity care from the UK and Ireland Confidential Enquiries into Maternal Deaths and Morbidity 2014-16. Oxford: University of Oxford; 2018
Jno-Baptiste B, Scarlett MD, Harding H, Ehikmetalor K: The Effect of Dexamethasone on Post-operative Opioid Requirement in Patients who Underwent Gynecology Surgery at the University Hospital in Jamaica. Journal of Anesthesia & Clinical Research. 2014;5(11):5
Sutton CD, Carvalho B. Optimal Pain Management After Cesarean Delivery. Anesthesiol Clin. 2017 Mar;35(1):107-124. doi: 10.1016/j.anclin.2016.09.010. Epub 2016 Dec 12.
PubMed 28131114De Oliveira GS Jr, Almeida MD, Benzon HT, McCarthy RJ. Perioperative single dose systemic dexamethasone for postoperative pain: a meta-analysis of randomized controlled trials. Anesthesiology. 2011 Sep;115(3):575-88. doi: 10.1097/ALN.0b013e31822a24c2.
PubMed 21799397Salerno A, Hermann R. Efficacy and safety of steroid use for postoperative pain relief. Update and review of the medical literature. J Bone Joint Surg Am. 2006 Jun;88(6):1361-72. doi: 10.2106/JBJS.D.03018.
PubMed 16757774Shalu PS, Ghodki PS. To Study the Efficacy of Intravenous Dexamethasone in Prolonging the Duration of Spinal Anesthesia in Elective Cesarean Section. Anesth Essays Res. 2017 Apr-Jun;11(2):321-325. doi: 10.4103/0259-1162.194537.
PubMed 28663614Cummings KC 3rd, Napierkowski DE, Parra-Sanchez I, Kurz A, Dalton JE, Brems JJ, Sessler DI. Effect of dexamethasone on the duration of interscalene nerve blocks with ropivacaine or bupivacaine. Br J Anaesth. 2011 Sep;107(3):446-53. doi: 10.1093/bja/aer159. Epub 2011 Jun 14.
PubMed 21676892Wu CL, Raja SN. Treatment of acute postoperative pain. Lancet. 2011 Jun 25;377(9784):2215-25. doi: 10.1016/S0140-6736(11)60245-6.
PubMed 21704871Liu K, Hsu CC, Chia YY. Effect of dexamethasone on postoperative emesis and pain. Br J Anaesth. 1998 Jan;80(1):85-6. doi: 10.1093/bja/80.1.85.
PubMed 9505784Desmet M, Braems H, Reynvoet M, Plasschaert S, Van Cauwelaert J, Pottel H, Carlier S, Missant C, Van de Velde M. I.V. and perineural dexamethasone are equivalent in increasing the analgesic duration of a single-shot interscalene block with ropivacaine for shoulder surgery: a prospective, randomized, placebo-controlled study. Br J Anaesth. 2013 Sep;111(3):445-52. doi: 10.1093/bja/aet109. Epub 2013 Apr 15.
PubMed 23587875Mathew R, Radha KR, Hema VR. Effect of Perineural and Intravenous Dexamethasone on Duration of Analgesia in Supraclavicular Brachial Plexus Block with Bupivacaine: A Comparative Study. Anesth Essays Res. 2019 Apr-Jun;13(2):280-283. doi: 10.4103/aer.AER_15_19.
PubMed 31198245
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Controlled Trial Comparing the Effect of Intravenous Dexamethasone vs. Placebo on the Duration of Analgesia of Spinal Anaesthesia for Caesarean Sections at the Victoria Jubilee Hospital in Jamaica
- ClinicalTrials.gov ID
- NCT04624360
- Acronym / sponsor ID
- VJH Dexa Study
- Conditions
- Pain, Postoperative
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- The University of The West IndiesUniversity, hospital or other
- Collaborators
- National Health Fund of Jamaica
- Study start
- 27 Jun 2020 (actual)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 10 Nov 2020 (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.
Dexamethasone is one of many adjuncts tested to prolong the duration of spinal anesthesia and its analgesic effect. The intent of this, a single-site, double-blinded, randomized controlled trial, is to determine if a single intravenous (IV) 8 mg dose of Dexamethasone given after clamping of the umbilical cord at Caesarean section will prolong the duration of analgesia provided by spinal anesthesia when compared to placebo. This has the power to determine if the findings in previous studies hold true in the population of women who undergo C-sections at the Victoria Jubilee Hospital. This method does not require expert skill and equipment, as such, it can be easily implemented, with no major adverse effects in the population described and provide an effective option for multimodal analgesia.
Detailed description
This study is being conducted in accordance with the Good Clinical Practice guidelines as enunciated in the international Conference on Harmonization (ICP/GCP) of 2016 and the Declaration of Helsinki, 2013.
Sample Size:
The sample size calculated based on a study done by Shahraki et al who studied the efficacy of intravenous Dexamethasone in prolonging the duration of Spinal Anesthesia in elective Caesarean Section in an Indian population (36).
The following values were used for the calculation of the sample size: the required value of α was 5%, β was 10%, a clinically significant difference in Visual Analogue Scale (VAS) score at 1-hour post-surgery was considered 2 and the expected standard deviation was 2.5 (36). The equation used was:
n = (Zα/2+Zβ)2 *2*σ2 / d2,
where Zα/2 is the critical value of the normal distribution at α/2 (α is 0.05), Zβ is the critical value of the normal distribution at β of 0.10. σ2 is the population variance (2.52), and d is the difference to be detected (2). The calculated sample size is 14 patients in each group. In order allow for a potential loss of data up to 10% the target sample size required would be 16 in each group.
Assumptions:
- The population size is limited by:
- patient's age,
- gestational age,
- the type of birth - only Caesarian births,
- use of a single hospital - VJH
- the duration of the research of approximately 2 to 3 months.
- As a result of item 1, when the Finite Population model is used to determine the sample size -
S = Z2 * p(p-1) / E2
1 + (Z2 * p(p-1) / E2N)
Other parameters include:
- 95% Confidence level
- Margin of error 5%
- Number of live births at VJH in 2016 estimated at 8140 live births
- Number of Caesarian births same period = 1652
- Percent of Caesarian births (with access to in 2 to 3 months) = 3.6 to 5%
The computed sample size ranges from 53 (2 months) to 72 (3 months) The decision was made to include 30 patients in each group totaling 60 persons for the sample size for this study.
Research assistants received training in the study protocol. Presentations were made to the registration clerks, obstetricians, midwives and other nursing staff to introduce them to the study.
Recruitment The registration clerk informs the patients of the study being carried out from admission to hospital. The ward nurse, upon admitting the patient, determine if they meet the criteria and indicates same to a member of the research team. Written informed consent is obtained by an independent research assistant, once it is confirmed that the patient meets the criteria, to avoid any perception of coercion on the night before or the morning of their procedure. The patient's autonomy is respected and quality medical care will is provided for those who participate in the study as well as those who decline.
Conceptual Definition of Variables Duration of analgesia: the time from intrathecal injection to the time of the first request for analgesia or Visual Analogue Pain Scale score > 4.
Duration of motor blockade: the time from intrathecal injection to the time when the patient is able to flex their knees with free movement of their feet in any plane.
Data Collection/ Storage The data collected for research is stored in a secured area in the Anesthetic Office at the Kingston Public Hospital with access limited to the research team only. Back-up of the data is stored off-site in a locked room in the Anesthetic Office of the University Hospital of the West Indies. Each patient is assigned a study number, and strict security measures are employed to ensure maximum protection of data and the privacy of the research subjects such as password protection and anonymity of data.
If a participant decides to withdraw from the study, the data collected prior to withdrawal may be used in data analysis and the same anonymity applies. Withdrawal from the study will not affect the participant's access to quality health care.
Source Data Verification This is done by cross-referencing the data entered on the data collection forms with the patients' dockets.
Statistical Analysis The data will be managed and analyzed using Statistical Package for the Social Sciences [SPSS] version 26.0 (2019). Uni-variate, bi-variate and multi-variate analysis of the data will be done. Uni-variate analysis will include means ± standard deviation. Bi-variate analysis will include will include independent/ paired t-tests for quantitative data; Chi square test and Mann-Whitney's U test where applicable. Multi-variate analysis will include regression and other measurements where necessary. A p value of less than 0.05 will be deemed statistically significant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Drug A | Experimental | Drug: DexamethasoneDexamethasone 8mg intravenous administration stat dose post clamping of the umbilical cord |
| Study Drug B | Placebo comparator | Other: PlaceboNormal saline 2cc intravenous stat dose administered after clamping of the umbilical cord |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Patients at Victoria Jubilee Hospital in Jamaica, scheduled for non-emergent LSCS under spinal anesthesia
- Age: 18 to 45 years
- Gestational Age: 37 weeks or more
- American Society of Anesthesiologists physical status class II
- Singleton fetus
Key exclusion criteria (18 listed)
- Emergent Indication for caesarean section including, but not limited to:
- Fetal distress
- Cord prolapse
- Eclampsia
- Severe pre-eclampsia
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 |
|---|---|---|
| DexamethasoneAlso: Study Drug AIntravenous of Dexamethasone 8 mg post clamping of the umbilical cord | Drug | Study Drug A |
| PlaceboAlso: Study Drug B2cc 0.9% Saline | Other | Study Drug B |
Primary outcome
Duration of analgesia
Time frame: first 4 hours after spinal anesthesia administered
The duration of time from the administration of drugs intrathecally for spinal anesthesia to the first request for analgesia or first time the pain score is greater than 4
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2020.
- Background: PubMed 15763409Joshi GP, Ogunnaike BO. Consequences of inadequate postoperative pain relief and chronic persistent postoperative pain. Anesthesiol Clin North Am. 2005 Mar;23(1):21-36. doi: 10.1016/j.atc.2004.11.013.
- Background: PubMed 16192541Carvalho B, Cohen SE, Lipman SS, Fuller A, Mathusamy AD, Macario A. Patient preferences for anesthesia outcomes associated with cesarean delivery. Anesth Analg. 2005 Oct;101(4):1182-1187. doi: 10.1213/01.ane.0000167774.36833.99.
- BackgroundJadon A, Bagai R. Effective pain relief after caesarean section; Are we on the right path or still on the crossroad. Journal of Obstetric Anaesthesia and Critical Care. 2019;9(1):3-6
- Background: PubMed 18818022Eisenach JC, Pan PH, Smiley R, Lavand'homme P, Landau R, Houle TT. Severity of acute pain after childbirth, but not type of delivery, predicts persistent pain and postpartum depression. Pain. 2008 Nov 15;140(1):87-94. doi: 10.1016/j.pain.2008.07.011. Epub 2008 Sep 24.
- BackgroundMarian Knight KB, Derek Tuffnell, Hemali Jayakody,Judy Shakespeare RK, Sara Kenyon,, Kurinczuk JJ. MBRRACE-UK: Saving Lives, Improving Mothers' Care - Lessons learned to inform maternity care from the UK and Ireland Confidential Enquiries into Maternal Deaths and Morbidity 2014-16. Oxford: University of Oxford; 2018
- BackgroundJno-Baptiste B, Scarlett MD, Harding H, Ehikmetalor K: The Effect of Dexamethasone on Post-operative Opioid Requirement in Patients who Underwent Gynecology Surgery at the University Hospital in Jamaica. Journal of Anesthesia & Clinical Research. 2014;5(11):5
- Background: PubMed 28131114Sutton CD, Carvalho B. Optimal Pain Management After Cesarean Delivery. Anesthesiol Clin. 2017 Mar;35(1):107-124. doi: 10.1016/j.anclin.2016.09.010. Epub 2016 Dec 12.
- Background: PubMed 21799397De Oliveira GS Jr, Almeida MD, Benzon HT, McCarthy RJ. Perioperative single dose systemic dexamethasone for postoperative pain: a meta-analysis of randomized controlled trials. Anesthesiology. 2011 Sep;115(3):575-88. doi: 10.1097/ALN.0b013e31822a24c2.
- Background: PubMed 16757774Salerno A, Hermann R. Efficacy and safety of steroid use for postoperative pain relief. Update and review of the medical literature. J Bone Joint Surg Am. 2006 Jun;88(6):1361-72. doi: 10.2106/JBJS.D.03018.
- Background: PubMed 28663614Shalu PS, Ghodki PS. To Study the Efficacy of Intravenous Dexamethasone in Prolonging the Duration of Spinal Anesthesia in Elective Cesarean Section. Anesth Essays Res. 2017 Apr-Jun;11(2):321-325. doi: 10.4103/0259-1162.194537.
- Background: PubMed 21676892Cummings KC 3rd, Napierkowski DE, Parra-Sanchez I, Kurz A, Dalton JE, Brems JJ, Sessler DI. Effect of dexamethasone on the duration of interscalene nerve blocks with ropivacaine or bupivacaine. Br J Anaesth. 2011 Sep;107(3):446-53. doi: 10.1093/bja/aer159. Epub 2011 Jun 14.
- Background: PubMed 21704871Wu CL, Raja SN. Treatment of acute postoperative pain. Lancet. 2011 Jun 25;377(9784):2215-25. doi: 10.1016/S0140-6736(11)60245-6.
- Individual participant dataSharing planned: Yes
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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.
Christine Stephen, MB;BS, DM principal investigator
University of the West Indies
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 Dexamethasone in people with Pain, Postoperative, run by The University of The West Indies at 1 site in Jamaica.
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 5 inclusion and 18 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 10 Nov 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 Jamaica. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Renee Nesbeth, M.B.;B.S. (8765758155, rmnesbeth@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of analgesia (time frame: first 4 hours after spinal anesthesia administered). 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 NCT04624360, which also lists 28 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 10 Nov 2020.