Pre- Versus Post-incisional Pregabalin for Postoperative Pain Attenuation and Analgesics Spare in Orthopedic Oncologic Patients

NCT01359059 | Unknown

• 1 other identifier: TASMC-11-HF-0248-11-CTIL
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Hypothesis No studies considered the comparison of preemptive vs. post-surgery Pregabalin (PGL) only administration. The investigators believe that the administration of PGL preemptively would diminish pain sensation and therefore the need for opioids administration in orthopedic-oncologic patients more effectively than if administered starting postoperatively.

Conditions

Postoperative Pain

Keywords

assess the beneficial effects of PGL administered either pre or post surgery; assess the satisfaction rate in the orthopedic oncologic patients

Outcome Measures

Primary Outcomes (1)

• To assess the beneficial effects of PGL administered either pre-incisionally or post-incisionally on the immediate and late (1- and 3 months) postoperative analgesia requirements and pain scores

  In the PACU (post-anesthesia care unit), the parameters (pain, sedation, feeling of anxiety, total morphine, fentanyl, and bupivacaine consumptions, PCA activation, antinociceptives PO/IV, overall maximal pain intensity throughout the study period) will be assessed by the attending physician every 15 min for the first postoperative hour and every 30 min thereafter. On the ward, vital signs will be recorded Q 8 h.

  2 years

Study Arms (2)

IV-PCA (Patient-controlled analgesia) morphine

ACTIVE COMPARATOR

Drug: Pregabalin

Patient controlled epidural analgesia (PCEA) fentanyl

ACTIVE COMPARATOR

Drug: Pregabalin

Interventions

Pregabalin DRUG

Patients in one set (40 patients/set) will receive 150 mg of PGL or placebo at 20:00 the evening before surgery and 1.5 h before surgery and will undergo surgery under GA. The 2nd set of patients will be randomized similarly but will undergo surgery under epidural analgesia. One physician whose duty in the study will end at the point of preoperative preparation will provide the patients with the preemptive drug. No other premedication will be administered to any patient. Post-operatively, patients who received preoperative PGL patients will be given placebo while the pre-surgery-placebo-treated ones will receive PGL, all at 2 h after surgery. All patients will then be given 150 mg twice daily thereafter, Q 12 h postoperatively up to 96 h.

IV-PCA (Patient-controlled analgesia) morphine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA physical status I-III patients who will undergo bone with or without soft tissue cancer surgery type II and III \[24,25\] under general or epidural anesthesia in Tel-aviv Sourasky Medical Center will be enrolled to this study that will be approved by our institutional human research and ethics committee.
• All participants will sign a Helsinki-approved informed consent, and will be given full explanation of the drug, PCA and the numerical rating scale (NRS) during the pre-anesthesia interview.

You may not qualify if:

• These will include allergy to opioids, bupivacaine, midazolam, PGL, or non-steroidal anti-inflammatory drugs (NSAIDs), a history of chronic pain or psychiatric disorders and the use of centrally acting drugs of any sort. Patients \<18 or \>80 years, soldiers and pregnant women will also be excluded from the study.

Sponsors & Collaborators

• Tel-Aviv Sourasky Medical Center: lead

Study Sites (1)

Tel Aviv Sourasky Medical Center

Tel Aviv, Weizman 6, 64239, Israel

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Pregabalin

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Avi Weinbroum, MD

  Tel-Aviv Sourasky Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

AVI Weinbroum, MD

CONTACT

972-524266459; aviw@tasmc.health.gov.il

Elia Dery, MSc

CONTACT

972-36974093; eliadery@zahav.net.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: May 18, 2011
• First Posted: May 24, 2011
• Study Start: June 1, 2011
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: June 10, 2011

Record last verified: 2011-06

Locations

IL (1)