Post Operative PaineppsNCT03056521
Effect of Preoperative Information About Pain on Postoperative Pain Experience and Patient Satisfaction
A study testing preoperative information about pain in people with Post Operative Pain, run by Makerere University at 1 site in Uganda.
Trial summary
Patients are randomized into 2 groups. The intervention group which receives preoperative counseling about pain and a control group which does not receive this counseling. The patients are followed up looking at pain scores and pain experience and satisfaction with pain management for 2 days post operative. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Post Operative Pain
- What is being tested?
- preoperative information about pain
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 340 participants
- Where
- 1 siteUganda
- Study dates
- Jun 2016to 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age of 18 years and above
- Elective orthopedic surgery patients admitted to orthopedic/trauma ward Mulago hospital
- Patient who gives consent
Who cannot join
- Patients with chronic pain not related to the surgery they are to undergo
- Patients with bone cancer
- Inability to speak or hear (deaf or dumb)
- Previously recruited but comes for re-surgery for same condition
Trial locations and contacts
1 site in 1 country.
Uganda1 site, 1 recruiting
- Recruiting
Mulago National Referral Hospital
Kampala, +256
Claire Lubulwa, +256 782 444854, lubulwac@gmail.com
Mark Kasumba, +256 793 625678
About this study
Official title: Effect of Preoperative Information About Pain on Postoperative Pain Experience and Patient Satisfaction in Adult Elective Orthopedic Patients: A Randomized Controlled Trial
Patients are randomized into 2 groups. The intervention group which receives preoperative counseling about pain and a control group which does not receive this counseling.
The patients are followed up looking at pain scores and pain experience and satisfaction with pain management for 2 days post operative.
Read the detailed description
- All patients admitted for elective upper and lower limb surgery, will be expected to have a preoperative visit by the anesthetic provider on the day before surgery.
- Those who will have consented to participate in the study will be randomized to either the intervention or control group.
- The intervention group will receive specific preoperative information about pain in private by the principal investigator in addition to the preoperative assessment.
- The following variables will be recorded preoperatively: socio-demographics (age, gender, tribe, education level) and vital signs (pulse rate, blood pressure and oxygen saturation).
- A Numerical pain score will be explained to patient before it is recorded preoperatively.
- The patient will also be informed that the pain scores will be repeated after surgery at (someone will take the pain scores again after surgery at) 0, 6, 12, 24, 48hours or till discharge if less than 48hours. In addition the pulse rate, number of analgesic intravenous/ intramuscular injections or tablets needed/or given will be recorded.
- Assessed pain will be classified as no pain (1-3), pain (4-10) but also as no pain (0), mild (1-3), moderate (4-6) and severe pain (7-10).
- Intra operatively, the anaesthetic technique (general or regional), medications given, duration of surgery will be recorded in) the questionnaires.
- Conditions
- Post Operative Pain
- Being tested
- preoperative information about pain
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
preoperative information about painOther
It is information about analgesics, post operative pain, complications of pain, benefits of pain treatment and non pharmacologic treatment options.
| Study group | Role | What they receive |
|---|---|---|
| Info | Experimental | In this arm the patients are counseled preoperatively about post operative pain.
Specific information about post operative pain which includes both pharmacologic and non-pharmacologic treatments, complications of pain and benefits of good pain management. This is in addition to the routine care provided Receives: Other: preoperative information about pain |
| No info | No intervention | These patients are in the control group. They are left to receive only the routine preoperative care as made available to them while on ward. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post operative pain experience (yes or no answer)
Patients subjectively tell you if their pain has been adequately controlled with a yes or no answer
Measured: 2 days
Patient satisfaction (answer yes or no)
Is the patient happy with how the pain has been managed answer yes or no
Measured: 2 days
Secondary outcomes (1)
Time to ambulation
when does the patient start doing some activity with the operated limb less than or greater than 3 days
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2017
- Study startJun 2016
- Primary completionFeb 2017 (estimated)
- Study completionMar 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Operative PainStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 340 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Makerere University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Moses Othin, Principal investigator, Makerere University College of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03056521
- Sponsor's protocol ID
- 2014/HD07/939U
- Acronym
- epps
- Status last verified
- Feb 2017
- First submitted
- 15 Feb 2017
- Last updated
- 17 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Preoperative Information About Pain on Postoperative Pain Experience and Patient Satisfaction in Adult Elective Orthopedic Patients: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03056521
- Acronym / sponsor ID
- epps / 2014/HD07/939U
- Conditions
- Post Operative Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 340 participants (estimated)
- Lead sponsor
- Makerere UniversityUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- Feb 2017 (estimated)
- Study completion
- Mar 2017 (estimated)
- First posted
- 17 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.
Patients are randomized into 2 groups. The intervention group which receives preoperative counseling about pain and a control group which does not receive this counseling.
The patients are followed up looking at pain scores and pain experience and satisfaction with pain management for 2 days post operative.
Detailed description
- All patients admitted for elective upper and lower limb surgery, will be expected to have a preoperative visit by the anesthetic provider on the day before surgery.
- Those who will have consented to participate in the study will be randomized to either the intervention or control group.
- The intervention group will receive specific preoperative information about pain in private by the principal investigator in addition to the preoperative assessment.
- The following variables will be recorded preoperatively: socio-demographics (age, gender, tribe, education level) and vital signs (pulse rate, blood pressure and oxygen saturation).
- A Numerical pain score will be explained to patient before it is recorded preoperatively.
- The patient will also be informed that the pain scores will be repeated after surgery at (someone will take the pain scores again after surgery at) 0, 6, 12, 24, 48hours or till discharge if less than 48hours. In addition the pulse rate, number of analgesic intravenous/ intramuscular injections or tablets needed/or given will be recorded.
- Assessed pain will be classified as no pain (1-3), pain (4-10) but also as no pain (0), mild (1-3), moderate (4-6) and severe pain (7-10).
- Intra operatively, the anaesthetic technique (general or regional), medications given, duration of surgery will be recorded in) the questionnaires.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Info | Experimental | Other: preoperative information about painIn this arm the patients are counseled preoperatively about post operative pain. Specific information about post operative pain which includes both pharmacologic and non-pharmacologic treatments, complications of pain and benefits of good pain management. This is in addition to the routine care provided |
| No info | No intervention | –These patients are in the control group. They are left to receive only the routine preoperative care as made available to them while on ward. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age of 18 years and above
- Elective orthopedic surgery patients admitted to orthopedic/trauma ward Mulago hospital
- Patient who gives consent
Key exclusion criteria (4 listed)
- Patients with chronic pain not related to the surgery they are to undergo
- Patients with bone cancer
- Inability to speak or hear (deaf or dumb)
- Previously recruited but comes for re-surgery for same condition
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 |
|---|---|---|
| preoperative information about painIt is information about analgesics, post operative pain, complications of pain, benefits of pain treatment and non pharmacologic treatment options. | Other | Info |
Primary outcome
Post operative pain experience (yes or no answer)
Time frame: 2 days
Patients subjectively tell you if their pain has been adequately controlled with a yes or no answer
Patient satisfaction (answer yes or no)
Time frame: 2 days
Is the patient happy with how the pain has been managed answer yes or no
1 secondary outcome
Time to ambulation
Time frame: 3 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2017.
- 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.
Moses Othin principal investigator
Makerere University College of Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing preoperative information about pain in people with Post Operative Pain, run by Makerere University at 1 site in Uganda.
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 3 inclusion and 4 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 17 Feb 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 Uganda. 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 Moses Othin (+256 753 020430, othinm@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post operative pain experience (yes or no answer) (time frame: 2 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Feb 2017.