Clinical trial NCT01063790: The Effect of an Individualized Education Intervention on Pain Following Inguinal Hernia Repair Surgery
Official title: The Effect of an Individualized Education Intervention Versus Usual Care on Pain Following Ambulatory Inguinal Hernia Repair
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Pain
Keywords: Post-operative pain
inguinal hernia repair surgery
Patient education
Lead sponsor: University of Toronto
Sponsor class: OTHER
Collaborators: name: Unity Health Toronto
First posted: 2010-02-05
Enrollment: 82
Sex: MALE
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Pain after inguinal hernia repair surgery is common with more than 50% of patients reporting moderate to severe acute pain following surgery. Analgesics are helpful in managing this pain but patients can be reluctant to take analgesics due to potential adverse effects such as nausea, vomiting or constipation. Patients may also be concerned about addiction to analgesics or they may believe that experiencing moderate to severe pain after surgery is to be expected.

The purpose of this study is to investigate the impact of an individualized education program regarding pain and management of adverse effects on pain after inguinal hernia repair surgery.

Detailed description: There is clear evidence that patients who have undergone ambulatory inguinal hernia (IHR) repair have significant pain following surgery. Inguinal hernia repair has been identified as one of the most painful ambulatory surgery procedures, with 98% of patients reporting pain 24 hours following IHR surgery, and 54% of patients experiencing moderate to severe pain in the first 72 hours. Despite experiencing continued pain, patients do not always take the prescribed analgesics. Analgesics are helpful in managing post-operative pain but may have adverse effects, including nausea, vomiting or constipation, which are often not managed. Almost half of all patients who undergo ambulatory surgery experience these adverse effects with 45% experiencing constipation and 46% experiencing nausea and/or vomiting in the first 48 hours after surgery.

As well, patients may have concerns about addiction, or asking for help to manage their pain and may believe that moderate to severe pain is to be expected, contributes to healing and therefore is to be tolerated following surgery. Patients are expected to manage this pain and adverse effects of analgesics at home. Minimal research has been found regarding interventions to manage pain following ambulatory surgery, and none found specifically for patients undergoing inguinal hernia repair.

The purpose of this trial is to investigate the impact of an individualized pre-operative pain education intervention that includes a booklet with telephone support pre-operatively and after discharge home versus usual care for patients having IHR surgery. The primary outcome will be worst pain on movement in the past 24 hours and the secondary outcomes will be pain related interference, pain quality, analgesic use and adverse effects, and patient satisfaction and concerns with pain management.

Eligibility criteria: Inclusion Criteria:

* male
* able to speak, read and understand English,
* have telephone access.
* are scheduled for a unilateral inguinal hernia repair.

Exclusion Criteria:

* patients scheduled for a repeat IHR on the same surgical side
* patients who have emergency surgery.
* patients undergoing bilateral inguinal hernia repair.

Primary outcomes:
measure: The primary outcome measure is pain intensity using a 0 to 10 numeric rating scale.
timeFrame: Second post-operative day
Secondary outcomes:
measure: Secondary measures include: quality of pain, pain related interference, analgesic use, prevalence and intensity of adverse effects of analgesics, patient concerns regarding pain management, and adequacy of post-discharge information.
timeFrame: 7 days after surgery
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
Study officials:
affiliation: University of Toronto
name: Judy Watt-Watson, RN, PhD
role: PRINCIPAL_INVESTIGATOR
References: