- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00500565
Pain Management Following TRAM Flap for Breast Reconstruction
Randomized, Double Blind, Controlled Trial of Two Methods of Postoperative Pain Management Following Free Transverse Rectus Abdominous Musculocutaneous (TRAM) Flap for Breast Reconstruction
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Inadequate control of surgical pain after free TRAM procedures may lead to complications and delay recovery time. This could lead to a longer stay in the hospital. The standard care for pain after a free TRAM procedure has been with drugs that are anesthetics. Unfortunately, these anesthetics are not long lasting and usually require the use of opioids (morphine or hydromorphone) to control "break-through" pain. A continuous delivery of local anesthetic to the wound site may provide better control of pain and decrease the need for the use of opioids. This may decrease the length of the hospital stay as well as other side effects associated with the treatment of pain.
Before the study, you will be asked questions about your health, your age, and about any allergies you may have. Women who are able to have children must have a negative blood pregnancy test. You will have already been scheduled to undergo a free TRAM flap procedure.
During free TRAM flap procedure, you will have two "soaker catheters" placed by the surgeon directly into the surgical site. The catheters are flexible tubes which will allow pain medicine (or saline) to be delivered directly to the donor wound site which is the abdominal site from where the tissue for breast reconstruction is taken. A small pump (On-Q pump) will be connected to the catheter to deliver a constant flow of pain medicine (or saline) for up to 5 days. The On-Q pump is completely portable and can be attached to your hospital gown to allow for movement.
You will be randomly assigned (as in the toss of a coin) to one of two groups. Participants in the first group will have the On-Q pump filled with saline. Participants in the other group will have the On-Q pump filled with bupivicaine.
Participants in both groups will receive IVPCA, which is the standard of care for pain relief. The IVPCA will be placed on PRN mode which means you will be able to press a button to deliver pain medication whenever you feel pain.
You will be asked questions about your pain and your recovery process every 6 hours while you are awake for up to 5 days. You will also be asked to fill out a questionnaire about pain once a day during treatment. It should take around 10 minutes to complete the questionnaire.
The catheters will be removed after 5 days of treatment (or your last day in the hospital, whichever is sooner) by one of the surgeons that participated in the surgery
During the study, if you experience any intolerable side effects or your doctor feels it is in your best interest to stop treatment, you will be taken off the study and other treatment options will be discussed with you.
This is an investigational study. The On-Q device, PCA, and bupivicaine are FDA approved and commercially available. Up to 60 participants will take part in this study (30 in each group). All will be enrolled at The University of Texas (UT) MD Anderson Cancer Center (MDACC).
This protocol is partially funded by a research grant from the I-Flow Corporation.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
Texas
-
Houston, Texas, Forenede Stater, 77030
- U.T.M.D. Anderson Cancer Center
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Patients with or undergoing unilateral elective free TRAM flap for breast reconstruction, immediate or delayed, with or without a surgical revision of the contralateral breast for asymmetry.
- American Society of Anesthesiology Physical Status I - III patients.
- Patients has given voluntary written informed consent before performance of any study-related procedure.
Exclusion Criteria:
- Patients undergoing bilateral TRAM flap reconstruction.
- Patients with a prior allergic reaction to Marcaine (bupivacaine) or other amide local anesthetics.
- Patients with a prior allergic reaction to Morphine and Hydromorphone.
- Patients undergoing any other unrelated surgical procedure to the breast reconstruction.
- Patient refusal to participate.
- Patient required major abdominal surgery within four weeks prior to enrollment.
- Patients being treated for chronic pain or using daily intake of opioid analgesics.
- Patients with a history of abuse of recreational drugs or alcohol.
- Patients with any laboratory values or underlying disease, which in the investigator's opinion would preclude them from participation in the trial, specifically: (A) significant liver dysfunction (eg. bilirubin, AST and/or ALT >1.5 times the upper limit of normal value (B) cardiac conduction defects noted by history or on the pre-op screening EKG.
- Pregnant or breast feeding.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: On-Q pump with Saline
On-Q Pump with Saline
|
On-Q Pain Pump filled with Saline.
The On-Q pump will be connected to the catheter to deliver a constant flow of saline for up to 5 days.
|
Eksperimentel: On-Q Pump with Bupivicaine
On-Q Pump with bupivicaine
|
On-Q Pain Pump filled with 0.375% Bupivicaine through two catheters at a total rate of 4 cc/hr over 111 hours.
The On-Q pump will be connected to the catheter to deliver a constant flow of Bupivicaine for up to 5 days.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Total Postoperative Opioid Use by Patient
Tidsramme: Measurements performed and recorded every 6 hours while patient is hospitalized.
|
Measurements performed and recorded every 6 hours while patient is hospitalized.
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Charles E. Butler, MD, M.D. Anderson Cancer Center
Publikationer og nyttige links
Hjælpsomme links
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- ID03-0046
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