Ignite Creation Date:
2024-05-06 @ 8:28 AM
Last Modification Date:
2024-10-26 @ 12:00 PM
Study NCT ID:
NCT02740114
Status:
TERMINATED
Last Update Posted:
2021-10-18
First Post:
2016-04-12
Brief Title:
Wound Infiltration With Liposomal Bupivacaine vs Standard Wound Infiltration With Bupivacaine in Patients Undergoing Open Gynecologic Surgery on an Enhanced Recovery Pathway
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Wound Infiltration With Liposomal Bupivacaine vs Standard Wound Infiltration With Bupivacaine in Patients Undergoing Open Gynecologic Surgery on an Enhanced Recovery Pathway A Single-Blinded Randomized Controlled Study
Status:
TERMINATED
Status Verified Date:
2021-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Per PIs request
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Bupivacaine is a drug that is traditionally given as an injection to numb surgical sites Liposomes are molecules that are similar to fats Sometimes drugs are combined with liposomes to make them able to stay in the body for longer periods of time This has been done with bupivacaine to create liposomal bupivacaine
The goal of this clinical research study is to compare the effects of bupivacaine to those of liposomal bupivacaine when given to patients who are having gynecologic surgery Researchers want to compare how long the drugs work to numb the wound and how long patients take to recover from surgery
The goal of this clinical research study is to compare the effects of bupivacaine to those of liposomal bupivacaine when given to patients who are having gynecologic surgery Researchers want to compare how long the drugs work to numb the wound and how long patients take to recover from surgery
Detailed Description:
Study Arms and Drug Administration
If you are found to be eligible to take part in this study you will be randomly assigned as in the flip of a coin to 1 of 2 study arms
If you are in Arm 1 you will receive bupivacaine only
If you are in Arm 2 you will receive a combination of liposomal bupivacaine and bupivacaine
You will have an equal 5050 chance of being assigned to either group You will not know what you are receiving However the study staff will know what you are receiving
In both cases the drugs will be injected into your skin and tissue at the end of your surgery right before the wound is closed
Study Data Collection
Every day while you are in the hospital recovering from surgery you will be asked questions about pain any side effects you may be having symptoms and opioid use
Within 30 days after you leave the hospital you may also be called and asked about side effects you may be having If you are called this call should last about 10-15 minutes This information may also be collected during a routinely scheduled clinic visit and from the medical record
Three 3 and 7 days after you leave the hospital and then 1 time every week after that for a total of 8 weeks you will be called or emailed and asked questions about any symptoms you may be having If you are called each call should last about 10-15 minutes
If you are also enrolled on the study BS99-094 Measuring the Symptom Distress of Cancer Patients Development of a New Assessment System information from your participation in this study may also be collected and used in that study
Length of Study
Your participation on this study will be over 8 weeks after you leave the hospital
This is an investigational study Both bupivacaine and liposomal bupivacaine are FDA approved and commercially available It is investigational to compare the 2 drugs
Up to 200 participants will be enrolled in this study All will take part at MD Anderson
If you are found to be eligible to take part in this study you will be randomly assigned as in the flip of a coin to 1 of 2 study arms
If you are in Arm 1 you will receive bupivacaine only
If you are in Arm 2 you will receive a combination of liposomal bupivacaine and bupivacaine
You will have an equal 5050 chance of being assigned to either group You will not know what you are receiving However the study staff will know what you are receiving
In both cases the drugs will be injected into your skin and tissue at the end of your surgery right before the wound is closed
Study Data Collection
Every day while you are in the hospital recovering from surgery you will be asked questions about pain any side effects you may be having symptoms and opioid use
Within 30 days after you leave the hospital you may also be called and asked about side effects you may be having If you are called this call should last about 10-15 minutes This information may also be collected during a routinely scheduled clinic visit and from the medical record
Three 3 and 7 days after you leave the hospital and then 1 time every week after that for a total of 8 weeks you will be called or emailed and asked questions about any symptoms you may be having If you are called each call should last about 10-15 minutes
If you are also enrolled on the study BS99-094 Measuring the Symptom Distress of Cancer Patients Development of a New Assessment System information from your participation in this study may also be collected and used in that study
Length of Study
Your participation on this study will be over 8 weeks after you leave the hospital
This is an investigational study Both bupivacaine and liposomal bupivacaine are FDA approved and commercially available It is investigational to compare the 2 drugs
Up to 200 participants will be enrolled in this study All will take part at MD Anderson
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2016-00739 | REGISTRY | NCI CTRP | None |