Trial Outcomes & Findings for Evaluate the Use of Paravertebral Block in Reconstructive Breast Surgery (NCT NCT00542542)
NCT ID: NCT00542542
Last Updated: 2015-04-13
Results Overview
Pain assessed using a verbal numeric rating scale (NRS) scored by numeric integers, with scores of 0-10 where 0 is no pain and 10 is the worst pain. Pain evaluated within the first hour, between 1 - 3 hours, between 3 - 6 hours post-operatively. Additional reporting planned for following morning (18 - 24 hours post-operatively).
COMPLETED
PHASE3
89 participants
Starting immediately after surgery, every 2 hours till the 6th hour following surgery
2015-04-13
Participant Flow
Recruitment Period: September 10, 2007 to February 28, 2011. All recruitment done at The University of Texas (UT) MD Anderson Cancer Center.
Of the 89 participants enrolled, one participant was excluded prior to group assignment.
Participant milestones
| Measure |
Group 1: Paravertebral Block + General Anesthesia
Paravertebral Block + General Anesthesia (Ropivacaine)
Paravertebral Block: Paravertebral block given as a bolus injection into the paravertebral space.
Ropivacaine: Ropivacaine given by injection into the paravertebral space along the spinal canal.
|
Group 2: General Anesthesia Alone
General Anesthesia Alone (Propofol, Midazolam, Fentanyl)
Propofol: 2-2.5 mg/kg IV over 1-4 hours during surgery.
Fentanyl: 50-250 mcg IV over 1-4 hours during surgery.
Midazolam: 0.08 mg/kg IV over 1-4 hours during the surgery.
|
|---|---|---|
|
Overall Study
STARTED
|
44
|
44
|
|
Overall Study
COMPLETED
|
44
|
44
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluate the Use of Paravertebral Block in Reconstructive Breast Surgery
Baseline characteristics by cohort
| Measure |
Group 1: Paravertebral Block + General Anesthesia
n=44 Participants
Paravertebral Block + General Anesthesia (Ropivacaine)
Paravertebral Block: Paravertebral block given as a bolus injection into the paravertebral space.
Ropivacaine: Ropivacaine given by injection into the paravertebral space along the spinal canal.
|
Group 2: General Anesthesia Alone
n=44 Participants
General Anesthesia Alone (Propofol, Midazolam, Fentanyl)
Propofol: 2-2.5 mg/kg IV over 1-4 hours during surgery.
Fentanyl: 50-250 mcg IV over 1-4 hours during surgery.
Midazolam: 0.08 mg/kg IV over 1-4 hours during the surgery.
|
Total
n=88 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
49 years
n=5 Participants
|
51 years
n=7 Participants
|
51 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
44 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
88 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
44 participants
n=5 Participants
|
44 participants
n=7 Participants
|
88 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Starting immediately after surgery, every 2 hours till the 6th hour following surgeryPopulation: Analysis was not possible from data collected due to reporting inconsistencies.
Pain assessed using a verbal numeric rating scale (NRS) scored by numeric integers, with scores of 0-10 where 0 is no pain and 10 is the worst pain. Pain evaluated within the first hour, between 1 - 3 hours, between 3 - 6 hours post-operatively. Additional reporting planned for following morning (18 - 24 hours post-operatively).
Outcome measures
Outcome data not reported
Adverse Events
Group 1: Paravertebral Block + General Anesthesia
Group 2: General Anesthesia Alone
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Farzin Goravanchi, Professor, Anesthesiology & Perioperative Medicine
University of Texas MD Anderson Cancer Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place