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

Post Operative Pain Clinical Trial

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Official title:

Effect of Preoperative Information About Pain on Postoperative Pain Experience and Patient Satisfaction in Adult Elective Orthopedic Patients: A Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03056521
• Other study ID #: 2014/HD07/939U
• Status: Recruiting
• Phase: N/A
• First received: February 15, 2017
• Last updated: February 16, 2017
• Start date: June 2016
• Est. completion date: March 2017

Study information

• Verified date: February 2017
• Source: Makerere University
• Contact: Moses Othin
• Phone: +256 753 020430
• Email: othinm[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 340
• Est. completion date: March 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative
• Post Operative Pain

Intervention

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.

Locations

Country	Name	City	State
Uganda	Mulago National Referral Hospital	Kampala

Sponsors (1)

Lead Sponsor	Collaborator
Makerere University

Country where clinical trial is conducted

Uganda, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Patient satisfaction (answer yes or no)	Is the patient happy with how the pain has been managed answer yes or no	2 days
Secondary	Time to ambulation	when does the patient start doing some activity with the operated limb less than or greater than 3 days	3 days