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Effect of Preoperative Information About Pain on Postoperative Pain Experience and Patient Satisfaction (epps)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03056521
Recruitment Status : Unknown
Verified February 2017 by Makerere University.
Recruitment status was:  Recruiting
First Posted : February 17, 2017
Last Update Posted : February 17, 2017
Sponsor:
Information provided by (Responsible Party):
Makerere University

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.


Condition or disease Intervention/treatment Phase
Post Operative Pain Other: preoperative information about pain Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 340 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Masking Description: The participants and the healthcare providers do not know which patient belongs to which arm
Primary Purpose: Treatment
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 Start Date : June 2016
Estimated Primary Completion Date : February 2017
Estimated Study Completion Date : March 2017

Arm Intervention/treatment
Experimental: Info

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

Other: preoperative information about pain
It is information about analgesics, post operative pain, complications of pain, benefits of pain treatment and non pharmacologic treatment options.

No Intervention: No info
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.



Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. Time to ambulation [ Time Frame: 3 days ]
    when does the patient start doing some activity with the operated limb less than or greater than 3 days



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03056521


Contacts
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Contact: Moses Othin +256 753 020430 othinm@gmail.com
Contact: Claire Lubulwa +256 782 444854 lubulwac@gmail.com

Locations
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Uganda
Mulago National Referral Hospital Recruiting
Kampala, Uganda, +256
Contact: Claire Lubulwa    +256 782 444854    lubulwac@gmail.com   
Contact: Mark Kasumba    +256 793 625678      
Sponsors and Collaborators
Makerere University
Investigators
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Principal Investigator: Moses Othin Makerere University College of Health Sciences
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Responsible Party: Makerere University
ClinicalTrials.gov Identifier: NCT03056521    
Other Study ID Numbers: 2014/HD07/939U
First Posted: February 17, 2017    Key Record Dates
Last Update Posted: February 17, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations