Analgesic Effect of Pregabalin in Patients Undergoing Total Abdominal Hysterectomy

Northwestern University

Status: Withdrawn

Conditions: Pain

Treatments: Drug: Pregabalin administration; Drug: Placebo administration

Study type: Interventional

Funder types: Other

Identifiers

NCT01466101

STU00025229

Details and patient eligibility

About

Pregabalin will decrease the total amount of opioid required in patients undergoing total abdominal hysterectomy. In addition, pregabalin will decrease the incidence of opioid-related side effects in patients undergoing total abdominal hysterectomy.

Sex: Female

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• ASA Physical Status 1-2
• Age 18-64
• BMI 18-35
• Scheduled for elective total abdominal hysterectomy (with or without bilateral salpingo-oophorectomy)
• Gender: Female
• Consent: Obtained

Exclusion criteria

• Patient refusal
• Allergy to study medication(s)
• Preoperative use of gabapentinoids
• Preoperative use of anticonvulsants
• Daily use of analgesics
• Hepatic disease
• Renal insufficiency (Cr >2.0)
• Alcohol or drug abuse
• Pregnancy
• Language: Non-English speaking
• Patient expected to remain intubated after procedure

Dropout:

• Patient request
• Surgeon request
• Allergic reaction to pregabalin
• Surgical procedure significantly altered from scheduled procedure

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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0 participants in 2 patient groups, including a placebo group

Pregabalin administration

Active Comparator group

Description:

Administration of pregabalin

Treatment:

Drug: Pregabalin administration

Placebo

Placebo Comparator group

Description:

Administration of placebo

Treatment:

Drug: Placebo administration