Perioperative Administration of Pregabalin for Pain After Mastectomy

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Study Completion Date

2010-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The investigators hypothesize that pregabalin will decrease post-operative pain scores and analgesic use following total mastectomy compared to placebo. The primary outcome will be acute postoperative pain, measured by a verbal numerical rating score (VNRS) and total analgesic consumption during postoperative 48 hours. The secondary outcome will be VNRS at 1 week and 1 month after operation.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Perioperative Administration of Pregabalin for Pain After Robot-assisted Endoscopic Thyroidectomy

NCT00905580

Pain, Postoperative

COMPLETED PHASE4

The Effects of Peri-operative Pregabalin Administration on Post-operative Analgesia in Patients Undergoing Coronary Bypass Grafting

NCT00623285

Postoperative Pain.

UNKNOWN PHASE3

The Effects of Anesthetics on Persistent Pain Following Breast Cancer Surgery

NCT03782896

Breast Cancer Chronic Post-Procedural Pain

COMPLETED

Perioperative Pregabalin and Continuous Wound Infusion for Pain Control Following Thoracotomy

NCT01726205

Post-thoracotomy Pain

COMPLETED PHASE4

Preoperative Pain Control in Liver Surgery Patients

NCT01923948

Pain, Postoperative Hepatocellular Carcinoma

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pain, Postoperative

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Placebo

Patients receive oral Placebo 1 hour prior to surgery, and 12 hours later

Group Type PLACEBO_COMPARATOR

Vitamin Complex (placebo)

Intervention Type DRUG

Vitamin Complex orally

Pregabalin

Patients receive oral pregabalin 1 hour prior to surgery, and 12 hours later

Group Type EXPERIMENTAL

Pregabalin

Intervention Type DRUG

Pregabalin 75 mg orally

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Pregabalin

Pregabalin 75 mg orally

Intervention Type DRUG

Vitamin Complex (placebo)

Vitamin Complex orally

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. American Society of Anesthesia physical status class I \& II
2. Age \> 20 and \< 70 years
3. Robot- assisted endoscopic thyroidectomy

Exclusion Criteria

1. Known or suspected allergy, sensitivity, or contraindication to pregabalin or any of the standardized medications
2. Body mass index ≥ 40 kg/m2
3. History of seizure disorder
4. Current therapy with pregabalin, gabapentin, or any opioid
5. Any other physical or psychiatric condition which may impair their ability to cooperate with post-operative study data collection
6. Insulin-dependent diabetes mellitus
7. Renal insufficiency (estimated glomerular filtration rate (eGFR) \< 60 mL/min/1.73 m2)

Minimum Eligible Age

21 Years

Maximum Eligible Age

69 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No