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Analgesic Effect of Pregabalin in Patients Undergoing Total Abdominal Hysterectomy

Analgesic Effect of Pregabalin in Patients Undergoing Total Abdominal Hysterectomy

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01466101
Enrollment
0
Registered
2011-11-07
Start date
2011-01-31
Completion date
Unknown
Last updated
2012-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain

Keywords

Hysterectomy, Pain, Pregabalin

Brief summary

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.

Interventions

DRUGPlacebo administration

Administration of placebo

DRUGPregabalin administration

Administration of pregabalin

Sponsors

Northwestern University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 64 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
total hydromorphone consumption24 hourstotal hydromorphone consumption 24 hours post operatively

Secondary

MeasureTime frameDescription
Pain Scores postoperativePost operative periodPost operative pain scores

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026