Effect of Preoperative Information About Pain on Postoperative Pain Experience and Patient Satisfaction (epps)
Primary Purpose
Post Operative Pain
Status
Unknown status
Phase
Not Applicable
Locations
Uganda
Study Type
Interventional
Intervention
preoperative information about pain
Sponsored by
About this trial
This is an interventional treatment trial for Post Operative Pain
Eligibility Criteria
Inclusion Criteria:
- Age of 18 years and above
- Elective orthopedic surgery patients admitted to orthopedic/trauma ward Mulago hospital
- Patient who gives consent
Exclusion Criteria:
- 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
Sites / Locations
- Mulago National Referral HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Info
No info
Arm Description
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
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.
Outcomes
Primary Outcome Measures
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
Patient satisfaction (answer yes or no)
Is the patient happy with how the pain has been managed answer yes or no
Secondary Outcome Measures
Time to ambulation
when does the patient start doing some activity with the operated limb less than or greater than 3 days
Full Information
NCT ID
NCT03056521
First Posted
February 15, 2017
Last Updated
February 16, 2017
Sponsor
Makerere University
1. Study Identification
Unique Protocol Identification Number
NCT03056521
Brief Title
Effect of Preoperative Information About Pain on Postoperative Pain Experience and Patient Satisfaction
Acronym
epps
Official Title
Effect of Preoperative Information About Pain on Postoperative Pain Experience and Patient Satisfaction in Adult Elective Orthopedic Patients: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Unknown status
Study Start Date
June 2016 (undefined)
Primary Completion Date
February 2017 (Anticipated)
Study Completion Date
March 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Makerere University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Operative Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Masking Description
The participants and the healthcare providers do not know which patient belongs to which arm
Allocation
Randomized
Enrollment
340 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Info
Arm Type
Experimental
Arm Description
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
Arm Title
No info
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
preoperative information about pain
Intervention Description
It is information about analgesics, post operative pain, complications of pain, benefits of pain treatment and non pharmacologic treatment options.
Primary Outcome Measure Information:
Title
Post operative pain experience (yes or no answer)
Description
Patients subjectively tell you if their pain has been adequately controlled with a yes or no answer
Time Frame
2 days
Title
Patient satisfaction (answer yes or no)
Description
Is the patient happy with how the pain has been managed answer yes or no
Time Frame
2 days
Secondary Outcome Measure Information:
Title
Time to ambulation
Description
when does the patient start doing some activity with the operated limb less than or greater than 3 days
Time Frame
3 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Age of 18 years and above
Elective orthopedic surgery patients admitted to orthopedic/trauma ward Mulago hospital
Patient who gives consent
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Moses Othin
Phone
+256 753 020430
Email
othinm@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Claire Lubulwa
Phone
+256 782 444854
Email
lubulwac@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Moses Othin
Organizational Affiliation
Makerere University College of Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mulago National Referral Hospital
City
Kampala
ZIP/Postal Code
+256
Country
Uganda
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Claire Lubulwa
Phone
+256 782 444854
Email
lubulwac@gmail.com
First Name & Middle Initial & Last Name & Degree
Mark Kasumba
Phone
+256 793 625678
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Effect of Preoperative Information About Pain on Postoperative Pain Experience and Patient Satisfaction
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