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

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.

Study Overview

• Status: Unknown
• Conditions: Post Operative Pain
• Intervention / Treatment: Other: preoperative information about pain

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 Type: Interventional
• Enrollment (Anticipated): 340
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Moses Othin; Phone Number: +256 753 020430; Email: othinm@gmail.com
• Study Contact Backup: Name: Claire Lubulwa; Phone Number: +256 782 444854; Email: lubulwac@gmail.com

Study Locations

• Uganda
  • Kampala, Uganda, +256
    • Recruiting
    • Mulago National Referral Hospital
    • Contact: Claire Lubulwa; Phone Number: +256 782 444854; Email: lubulwac@gmail.com
    • Contact: Mark Kasumba; Phone Number: +256 793 625678

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	2 days
Patient satisfaction (answer yes or no)	Is the patient happy with how the pain has been managed answer yes or no	2 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to ambulation	when does the patient start doing some activity with the operated limb less than or greater than 3 days	3 days

Collaborators and Investigators

• Sponsor: Makerere University
• Investigators: Principal Investigator: Moses Othin, Makerere University College of Health Sciences

Study record dates

Study Major Dates

• Study Start: June 1, 2016
• Primary Completion (Anticipated): February 1, 2017
• Study Completion (Anticipated): March 1, 2017

Study Registration Dates

• First Submitted: February 15, 2017
• First Submitted That Met QC Criteria: February 16, 2017
• First Posted (Actual): February 17, 2017

Study Record Updates

• Last Update Posted (Actual): February 17, 2017
• Last Update Submitted That Met QC Criteria: February 16, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: 2014/HD07/939U

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No