Clinical trial NCT03434847: Providing Patients Realistic Expectations of Postoperative Pain
Official title: The PPREOPP Study: Providing Patients Realistic Expectations of Postoperative Pain
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Pain, Postoperative
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2018-02-15
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, randomized, single-blind study
Primary purpose: SUPPORTIVE_CARE

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

Detailed 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Does perioperative education improve satisfaction with postoperative pain control at discharge?
timeFrame: Upon discharge, Day 1 - Day 7
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University in St. Louis
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Michael Bottros, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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.
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.
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. doi: 10.1016/s0020-7489(99)00010-3.
citation: Snyder-Ramos SA, Seintsch H, Bottiger 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):1753-1758. doi: 10.1213/01.ANE.0000153010.49776.E5.
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. doi: 10.4103/0259-1162.177187.
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.