Study Of The Efficacy And Safety Of Pregabalin Compared To Placebo For Treatment Of Post-Surgical Pain From Hysterectomy

Viatris

Status and phase: Completed; Phase 3

Conditions: Pain, Postoperative

Treatments: Drug: matched placebo; Drug: pregabalin (Lyrica)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00468845

A0081153

Details and patient eligibility

About

To assess the efficacy of pregabalin compared to placebo on pain following hysterectomy , measured using subject reported assessments of pain.

Enrollment: 501 patients

Sex: Female

Ages: 25 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• The subject will have elective total abdominal hysterectomy using a transverse incision with or without bilateral salpingo-oophorectomy. The total hysterectomy may, however, be cervix-sparing.
• The subject is expected to remain at the hospital (or intermediate care facility) for a minimum of 2 days following surgery.
• The subject's preoperative health is graded as the American Society of Anesthesiologist P1 to P2.

Exclusion criteria

• Subjects having vaginal hysterectomy (whether laparoscopically assisted or not)
• Subjects having additional procedures (such as those involving the bladder) at the same time as the total abdominal hysterectomy
• The use of nerve block, spinal anesthesia or epidural anesthesia for post-surgical pain control
• Subjects who have been using any opioid medications 2 weeks or more continuously within 3 months prior to the screening visit.
• The subject has taken any NSAID or any analgesic other than acetaminophen within 3 days prior to surgery or is unwilling to abstain from NSAIDs or other analgesics, except as specified in the protocol, during the study. (Subjects taking <325 mg per day of aspirin at a stable dose for at least 30 days before the first dose of study medication will be allowed to continue their aspirin regimen for the duration of the study).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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501 participants in 3 patient groups, including a placebo group

1

Experimental group

Treatment:

Drug: pregabalin (Lyrica)

Drug: pregabalin (Lyrica)

2

Experimental group

Treatment:

Drug: pregabalin (Lyrica)

Drug: pregabalin (Lyrica)

3

Placebo Comparator group

Treatment:

Drug: matched placebo