Surgical Pain After Inguinal Hernia Repair (SPAIHR)

Viatris

Status and phase: Completed; Phase 3

Conditions: Hernia, Inguinal; Pain, Postoperative

Treatments: Drug: placebo; Drug: Pregabalin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00551135

A0081171

Details and patient eligibility

About

The purpose of this study is to test whether pregabalin added to the standard of care with dosing starting preoperatively and continuing for 1 week post surgery will decrease the intensity of acute post-operative pain following inguinal hernia repair.

Enrollment: 425 patients

Sex: Male

Ages: 17 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• The subject will have elective ( the subject chooses, but does not have to undergo surgery for an emergency) open unilateral inguinal herniorraphy (hernia repair), using mesh Lichtenstein surgery procedure and under general anesthesia and fentanyl or sufentanil/propofol initiation and sevoflurane or isoflurane maintenance plus local anesthetic infiltration at the conclusion of surgery. Study surgery should be anticipated to be in the morning.
• Expected to be able to use and tolerate non-steroidal anti-inflammatory drugs (such as naproxen), tramadol, oxycodone, and acetaminophen/paracetamol for pain control after surgery.
• The subject will be available for a visit within 72 hours of the day of surgery if not admitted the night before for baseline assessments before taking any study medication, and then to receive study medication prior to the day before surgery.
• The subject is expected and agrees to remain at the hospital (or intermediate care facility) for a minimum of 3 hours following surgery.

Exclusion criteria

• Subjects with non elective or emergency surgery (must have the surgery no matter what), or hernia with incarceration (the trapping of abdominal contents within the hernia itself).
• Subjects with hernia repair that is not a primary repair. The planned use of nerve block or spinal/epidural/paravertebral anesthesia or surgery is not planned with general anesthesia.
• Subjects that are not allowed to receive the anesthesia agents indicated per protocol and general anesthesia.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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425 participants in 4 patient groups, including a placebo group

3

Experimental group

Treatment:

Drug: Pregabalin

Drug: Pregabalin

Drug: Pregabalin

4

Placebo Comparator group

Treatment:

Drug: placebo

2

Experimental group

Treatment:

Drug: Pregabalin

Drug: Pregabalin

Drug: Pregabalin

1

Experimental group

Treatment:

Drug: Pregabalin

Drug: Pregabalin

Drug: Pregabalin