Providing Patients Realistic Expectations of Postoperative Pain

Pain, Postoperative Clinical Trial

— PPREOPP  

Official title:

The PPREOPP Study: Providing Patients Realistic Expectations of Postoperative Pain

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03434847
• Other study ID #: 201709172
• Status: Terminated
• Phase: N/A
• Start date: October 21, 2017
• Est. completion date: January 16, 2018

Study information

• Verified date: August 2018
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Prospective, randomized, single-blind study, whether perioperative educational improves pain-related postoperative outcomes,

Description:

This is a prospective, randomized, single-blind study in 100 patients undergoing open colorectal surgery. If the hypothesis is confirmed, then patients who receive perioperative educational interventions to address their expectation about their postoperative pain will have improved pain-related postoperative outcomes.

Randomization and Blinding 100 eligible patients scheduled to undergo open colorectal surgery will be approached in the Center for Preoperative Assessment and Planning Clinic. At enrollment, each patient will be assigned a study number, which will match a previously prepared computer-generated list of randomization numbers to determine whether they will be in the intervention or control arm. Pre-operatively, all patients will complete an initial questionnaire. The patients in the intervention group (n=50) will, in addition to the standard pre-operative assessment, also receive pre-operative educational instruction of what to expect from a post-operative pain perspective including education material to take home.

For this study, deception will be used, with the reasoning that the patients' knowledge of the different education materials will affect their rating of the impact of the intervention on satisfaction scores.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: January 16, 2018
• Est. primary completion date: January 16, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age > 18 years

• Undergoing open colorectal surgery Able to understand and sign and informed consent form

Exclusion Criteria:

• Age < 18 years

• Unable to complete post-operative CMS questionnaire

• Inability to understand the English language Absolute contraindication to epidural placement (patient refusal, requiring resumption of therapeutic anticoagulation after surgery, anaphylaxis to local anesthetics, local or systemic infections, bleeding diathesis)

Related Conditions & MeSH terms

• Pain, Postoperative

Intervention

Other:
• Education
Participants who receive perioperative educational to address their expectation about their postoperative pain will have improved pain-related postoperative outcomes.

Locations

Country	Name	City	State
United States	Washington University in St. Louis	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

References & Publications (7)

Ghomrawi HM, Mancuso CA, Westrich GH, Marx RG, Mushlin AI; Expectations Discordance Study Group. Discordance in TKA expectations between patients and surgeons. Clin Orthop Relat Res. 2013 Jan;471(1):175-80. doi: 10.1007/s11999-012-2484-3. — View Citation

Kaur H, Singh G, Singh A, Sharda G, Aggarwal S. Evolving with modern technology: Impact of incorporating audiovisual aids in preanesthetic checkup clinics on patient education and anxiety. Anesth Essays Res. 2016 Sep-Dec;10(3):502-507. — View Citation

Koenen P, Bäthis H, Schneider MM, Fröhlich M, Bouillon B, Shafizadeh S. How do we face patients' expectations in joint arthroplasty? Arch Orthop Trauma Surg. 2014 Jul;134(7):925-31. doi: 10.1007/s00402-014-2012-x. Epub 2014 May 24. — View Citation

Noorian C, Aein F. Comparative investigation of the effectiveness of face-to-face verbal training and educational pamphlets on readiness of patients before undergoing non-emergency surgeries. J Educ Health Promot. 2015 May 19;4:45. doi: 10.4103/2277-9531.157231. eCollection 2015. — View Citation

Shuldham C. A review of the impact of pre-operative education on recovery from surgery. Int J Nurs Stud. 1999 Apr;36(2):171-7. Review. — View Citation

Snyder-Ramos SA, Seintsch H, Böttiger BW, Motsch J, Martin E, Bauer M. Patient satisfaction and information gain after the preanesthetic visit: a comparison of face-to-face interview, brochure, and video. Anesth Analg. 2005 Jun;100(6):1753-8. — View Citation

Waljee J, McGlinn EP, Sears ED, Chung KC. Patient expectations and patient-reported outcomes in surgery: a systematic review. Surgery. 2014 May;155(5):799-808. doi: 10.1016/j.surg.2013.12.015. Epub 2013 Dec 16. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Does perioperative education improve satisfaction with postoperative pain control at discharge?	The satisfaction with postoperative pain control will be assessed using an initial, post-operative and discharge questionnaire of participant's pain level, medications (if any) to manage pain, the affects of that pain management, and participant satisfaction of that pain control.	Upon discharge, Day 1 - Day 7

External Links

•   HCAHPS Patient Level Correlations