Trial Outcomes & Findings for Surgical Pain Control With Ropivacaine by Atomized Delivery (NCT NCT01480089)
NCT ID: NCT01480089
Last Updated: 2016-07-27
Results Overview
Participants are asked to rate their pain level using the visual analog scale (VAS). The VAS is a measurement of pain where respondents specify their level of pain by indicating a position along a continuous line between two end-points. The VAS used in this study was a horizontal line of 100 mm length anchored by two word descriptors - one word at each end: No pain (left end) and Very Severe Pain (right end). The VAS score is determined by measuring in millimeters from the left hand end of the line to the point that the patient marks. The VAS range is 0 to 100.
COMPLETED
PHASE4
56 participants
2 hours after surgery
2016-07-27
Participant Flow
Women undergoing minimally invasive laparoscopic surgery in urogynecology, benign gynecology, and gynecologic-oncology clinics were recruited. All women who were scheduled to undergo a minimally invasive hysterectomy for benign and cancerous conditions between February 2012 and March 2013 were invited to participate.
One enrolled participant was excluded from the trial before assignment to groups because her physician prescribed Ropivacaine and, consequently, the participant was converted to open label before study drug was assigned or administered.
Participant milestones
| Measure |
Atomized Intraperitoneal Saline (AIS)
Participants randomized to this arm are given atomized intraperitoneal saline(AIS) to the peritoneal cavity at the completion of surgery.
|
Intraperitoneal Ropivacaine(AIR)
Participants randomized to this arm receive atomized intraperitoneal ropivacaine (AIR). That is, 2 mg/kg of lean body mass up to no more than 200mg total dose is atomized and delivered into the peritoneal cavity at the completion of surgery.
|
|---|---|---|
|
Overall Study
STARTED
|
25
|
30
|
|
Overall Study
COMPLETED
|
25
|
30
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Surgical Pain Control With Ropivacaine by Atomized Delivery
Baseline characteristics by cohort
| Measure |
Intraperitoneal Ropivacaine(AIR)
n=25 Participants
Participants randomized to this arm receive atomized intraperitoneal ropivacaine (AIR). That is, 2 mg/kg of lean body mass up to no more than 200mg total dose is atomized and delivered into the peritoneal cavity at the completion of surgery.
|
Atomized Intraperitoneal Saline (AIS)
n=30 Participants
Participants randomized to this arm are given atomized intraperitoneal saline(AIS) to the peritoneal cavity at the completion of surgery.
|
Total
n=55 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
54.6 years
n=5 Participants
|
58.8 years
n=7 Participants
|
56.9 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
21 participants
n=5 Participants
|
22 participants
n=7 Participants
|
43 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
2 participants
n=5 Participants
|
5 participants
n=7 Participants
|
7 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Surgical Approach
Laparoscopic
|
11 participants
n=5 Participants
|
11 participants
n=7 Participants
|
22 participants
n=5 Participants
|
|
Surgical Approach
Robotic
|
14 participants
n=5 Participants
|
19 participants
n=7 Participants
|
33 participants
n=5 Participants
|
|
Attending Specialty
Benign Gynecology
|
2 participants
n=5 Participants
|
4 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Attending Specialty
Urogynecology
|
12 participants
n=5 Participants
|
14 participants
n=7 Participants
|
26 participants
n=5 Participants
|
|
Attending Specialty
Gynecologic Oncology
|
11 participants
n=5 Participants
|
12 participants
n=7 Participants
|
23 participants
n=5 Participants
|
|
Length of Hospital Stay
Less than 24 hours
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Length of Hospital Stay
24 to 48 hours
|
19 participants
n=5 Participants
|
23 participants
n=7 Participants
|
42 participants
n=5 Participants
|
|
Length of Hospital Stay
Greater than 48 hours
|
6 participants
n=5 Participants
|
7 participants
n=7 Participants
|
13 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 hours after surgeryPopulation: All individuals randomized are included in this analysis.
Participants are asked to rate their pain level using the visual analog scale (VAS). The VAS is a measurement of pain where respondents specify their level of pain by indicating a position along a continuous line between two end-points. The VAS used in this study was a horizontal line of 100 mm length anchored by two word descriptors - one word at each end: No pain (left end) and Very Severe Pain (right end). The VAS score is determined by measuring in millimeters from the left hand end of the line to the point that the patient marks. The VAS range is 0 to 100.
Outcome measures
| Measure |
Intraperitoneal Ropivacaine(AIR)
n=25 Participants
Participants randomized to this arm receive atomized intraperitoneal ropivacaine (AIR). That is, 2 mg/kg of lean body mass up to no more than 200mg total dose is atomized and delivered into the peritoneal cavity at the completion of surgery.
|
Atomized Intraperitoneal Saline (AIS)
n=30 Participants
Participants randomized to this arm are given atomized intraperitoneal saline(AIS) to the peritoneal cavity at the completion of surgery.
|
|---|---|---|
|
Post-op Pain With Atomized Intraperitoneal Ropivacaine (AIR)
|
2.536 millimeters
Standard Deviation 2.7
|
3.844 millimeters
Standard Deviation 3.0
|
SECONDARY outcome
Timeframe: 12 hours after surgeryPopulation: All individuals randomized are included in this analysis.
Participants are asked to rate their pain level using the visual analog scale (VAS). The VAS is a measurement of pain where respondents specify their level of pain by indicating a position along a continuous line between two end-points. The VAS used in this study was a horizontal line of 100 mm length anchored by two word descriptors - one word at each end: No pain (left end) and Very Severe Pain (right end). The VAS score is determined by measuring in millimeters from the left hand end of the line to the point that the patient marks. The VAS range is 0 to 100.
Outcome measures
| Measure |
Intraperitoneal Ropivacaine(AIR)
n=25 Participants
Participants randomized to this arm receive atomized intraperitoneal ropivacaine (AIR). That is, 2 mg/kg of lean body mass up to no more than 200mg total dose is atomized and delivered into the peritoneal cavity at the completion of surgery.
|
Atomized Intraperitoneal Saline (AIS)
n=30 Participants
Participants randomized to this arm are given atomized intraperitoneal saline(AIS) to the peritoneal cavity at the completion of surgery.
|
|---|---|---|
|
Post-op Pain With Atomized Intraperitoneal Ropivacaine (AIR)
|
2.154 millimeters
Standard Deviation 1.9
|
2.219 millimeters
Standard Deviation 2.00
|
Adverse Events
Intraperitoneal Ropivacaine(AIR)
Atomized Intraperitoneal Saline (AIS)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place