Clinical trial NCT03056521: Effect of Preoperative Information About Pain on Postoperative Pain Experience and Patient Satisfaction
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
Overall status: UNKNOWN
Phase: NA
Conditions: Post Operative Pain
Lead sponsor: Makerere University
Sponsor class: OTHER
First posted: 2017-02-17
Enrollment: 340
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Post operative pain experience (yes or no answer)
timeFrame: 2 days
measure: Patient satisfaction (answer yes or no)
timeFrame: 2 days
Secondary outcomes:
measure: Time to ambulation
timeFrame: 3 days
Other outcomes:
Locations:
city: Kampala
country: Uganda
facility: Mulago National Referral Hospital
Study officials:
affiliation: Makerere University College of Health Sciences
name: Moses Othin
role: PRINCIPAL_INVESTIGATOR
References: