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Completed

NCT Number: NCT01063790

The Effect of an Individualized Education Intervention on Pain Following Inguinal Hernia Repair Surgery

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.

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Key information

Conditions

Pain Neurologic Manifestations Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year–90 year

Sex eligibility

Male

Study type

Interventional

Phase

Early Phase 1

Primary location

St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

individualized education

Behavioral

The intervention consists of written information in the form of a booklet, an individualized face to face education session and two telephone support calls regarding post-discharge pain management, adverse effects of analgesics and common concerns about asking for help with pain.Participants in the intervention group will also receive two telephone support calls. The purpose of the telephone support calls is to readdress the information that patients received in the booklet and to clarify concerns regarding post-operative pain management that were discussed during the individualized education session.

Other names: inginal hernia repair, acute pain

Primary outcomes

  1. The primary outcome measure is pain intensity using a 0 to 10 numeric rating scale.

    Time frame: Second post-operative day

Secondary outcomes

  1. 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.

    Time frame: 7 days after surgery

Sponsors and collaborators

Lead sponsor

University of Toronto

Other

Collaborators

  • Unity Health Toronto

Registry information

Official study title

The Effect of an Individualized Education Intervention Versus Usual Care on Pain Following Ambulatory Inguinal Hernia Repair

Acronym: HREI

Important dates

Study start
2009
Primary completion
2011
Study completion
2012
First posted
Feb 5, 2010
Registry last updated
Jul 16, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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