Trial Outcomes & Findings for Local Anesthesia Versus Saline Serum in Surgical Incision of Colorectal or Hepatic Surgery (NCT NCT01075646)
NCT ID: NCT01075646
Last Updated: 2017-03-27
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
225 participants
Primary outcome timeframe
48 hours
Results posted on
2017-03-27
Participant Flow
Study recruitment took place at the hospital Universitari de Bellvitge in Barcelona, Spain, from April 2010 to April 2012 in the case of colorrectal surgery. In hepatic surgery the study recruitment took place at the same hospital, from April 2010 to June 2014.
In colorrectal surgery 117 patients were assessed for elegibility. Of these 50 patients were excluded before randomization including 23 with exclusion criteria and 18 with a surgical or organization reason. In hepatic surgery 108 patients were assesed for eligibility, 9 patients were excluded with a surgical reason.
Participant milestones
| Measure |
Ropivacaine Colorectal Surgery
After a bolus administration of Ropivacaine a perfusion ot the same anesthetic is initiated through an elastomeric wound during 48 hours
ropivacaine: Laparotomy of colorectal surgery: 10 ml bolus ropivacaine 0,75% + infusion with elastomeric pump with ropivacaine 0,38% at a 5ml/h.
Laparoscopy of colorectal surgery: 5 ml bolus ropivacaine 0,75% + infusion with elastomeric pump with ropivacaine 0,38% at a 2 ml/h.
|
Saline Solution Colorectal Surgery
After a bolus administration of saline solution a perfusion ot saline solution is initiated through an elastomeric wound during 48 hours
placebo: Laparotomy of colorectal surgery: 10 ml bolus saline solution 0.9% + infusion with elastomeric pump with saline solution 0.9% at a 5ml/h.
Laparoscopy of colorectal surgery: 10 ml bolus saline solution 0.9% + infusion with elastomeric pump with saline solution 0.9% at a 2 ml/h.
|
Ropivacaine Hepatic Surgery
After a bolus administration of Ropivacaine a perfusion ot the same anesthetic is initiated through an elastomeric wound during 48 hours Hepatic surgery: 10 ml of ropivacaine 0,45% + infusion with elastomeric pump with ropivacaine 0,23 at a 5ml/h.
|
Saline Solution Hepatic Surgery
After a bolus administration of saline solution a perfusion ot saline solution is initiated through an elastomeric wound during 48 hours Hepatic surgery: 10 ml de saline solution 0.9% + infusion with elastomeric pump with saline solution 0.9% at a 5ml/h
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
33
|
34
|
53
|
46
|
|
Overall Study
COMPLETED
|
29
|
31
|
52
|
44
|
|
Overall Study
NOT COMPLETED
|
4
|
3
|
1
|
2
|
Reasons for withdrawal
| Measure |
Ropivacaine Colorectal Surgery
After a bolus administration of Ropivacaine a perfusion ot the same anesthetic is initiated through an elastomeric wound during 48 hours
ropivacaine: Laparotomy of colorectal surgery: 10 ml bolus ropivacaine 0,75% + infusion with elastomeric pump with ropivacaine 0,38% at a 5ml/h.
Laparoscopy of colorectal surgery: 5 ml bolus ropivacaine 0,75% + infusion with elastomeric pump with ropivacaine 0,38% at a 2 ml/h.
|
Saline Solution Colorectal Surgery
After a bolus administration of saline solution a perfusion ot saline solution is initiated through an elastomeric wound during 48 hours
placebo: Laparotomy of colorectal surgery: 10 ml bolus saline solution 0.9% + infusion with elastomeric pump with saline solution 0.9% at a 5ml/h.
Laparoscopy of colorectal surgery: 10 ml bolus saline solution 0.9% + infusion with elastomeric pump with saline solution 0.9% at a 2 ml/h.
|
Ropivacaine Hepatic Surgery
After a bolus administration of Ropivacaine a perfusion ot the same anesthetic is initiated through an elastomeric wound during 48 hours Hepatic surgery: 10 ml of ropivacaine 0,45% + infusion with elastomeric pump with ropivacaine 0,23 at a 5ml/h.
|
Saline Solution Hepatic Surgery
After a bolus administration of saline solution a perfusion ot saline solution is initiated through an elastomeric wound during 48 hours Hepatic surgery: 10 ml de saline solution 0.9% + infusion with elastomeric pump with saline solution 0.9% at a 5ml/h
|
|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
4
|
3
|
1
|
2
|
Baseline Characteristics
Local Anesthesia Versus Saline Serum in Surgical Incision of Colorectal or Hepatic Surgery
Baseline characteristics by cohort
| Measure |
Ropivacaine Colorectal Surgery
n=33 Participants
After a bolus administration of Ropivacaine a perfusion ot the same anesthetic is initiated through an elastomeric wound during 48 hours
ropivacaine: Laparotomy of colorectal surgery: 10 ml bolus ropivacaine 0,75% + infusion with elastomeric pump with ropivacaine 0,38% at a 5ml/h.
Laparoscopy of colorectal surgery: 5 ml bolus ropivacaine 0,75% + infusion with elastomeric pump with ropivacaine 0,38% at a 2 ml/h.
|
Saline Solution Colorectal Surgery
n=34 Participants
After a bolus administration of saline solution a perfusion ot saline solution is initiated through an elastomeric wound during 48 hours
placebo: Laparotomy of colorectal surgery: 10 ml bolus saline solution 0.9% + infusion with elastomeric pump with saline solution 0.9% at a 5ml/h.
Laparoscopy of colorectal surgery: 10 ml bolus saline solution 0.9% + infusion with elastomeric pump with saline solution 0.9% at a 2 ml/h.
|
Ropivacaine Hepatic Surgery
n=53 Participants
After a bolus administration of Ropivacaine a perfusion ot the same anesthetic is initiated through an elastomeric wound during 48 hours Hepatic surgery: 10 ml of ropivacaine 0,45% + infusion with elastomeric pump with ropivacaine 0,23 at a 5ml/h.
|
Saline Solution Hepatic Surgery
n=46 Participants
After a bolus administration of saline solution a perfusion ot saline solution is initiated through an elastomeric wound during 48 hours Hepatic surgery: 10 ml de saline solution 0.9% + infusion with elastomeric pump with saline solution 0.9% at a 5ml/h
|
Total
n=166 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
64 years
n=99 Participants
|
64.5 years
n=107 Participants
|
63.62 years
n=206 Participants
|
59.73 years
n=7 Participants
|
62.96 years
n=31 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
17 Participants
n=7 Participants
|
52 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=99 Participants
|
26 Participants
n=107 Participants
|
39 Participants
n=206 Participants
|
29 Participants
n=7 Participants
|
114 Participants
n=31 Participants
|
|
Hypertension
Yes
|
15 participants
n=99 Participants
|
17 participants
n=107 Participants
|
23 participants
n=206 Participants
|
15 participants
n=7 Participants
|
70 participants
n=31 Participants
|
|
Hypertension
No
|
18 participants
n=99 Participants
|
17 participants
n=107 Participants
|
30 participants
n=206 Participants
|
31 participants
n=7 Participants
|
96 participants
n=31 Participants
|
|
Diabetes
Yes
|
10 participants
n=99 Participants
|
7 participants
n=107 Participants
|
10 participants
n=206 Participants
|
11 participants
n=7 Participants
|
38 participants
n=31 Participants
|
|
Diabetes
No
|
23 participants
n=99 Participants
|
27 participants
n=107 Participants
|
43 participants
n=206 Participants
|
35 participants
n=7 Participants
|
128 participants
n=31 Participants
|
|
Antiplatelet drugs
Yes
|
5 participants
n=99 Participants
|
4 participants
n=107 Participants
|
3 participants
n=206 Participants
|
1 participants
n=7 Participants
|
13 participants
n=31 Participants
|
|
Antiplatelet drugs
No
|
28 participants
n=99 Participants
|
30 participants
n=107 Participants
|
50 participants
n=206 Participants
|
45 participants
n=7 Participants
|
153 participants
n=31 Participants
|
|
Anemia
Yes
|
3 participants
n=99 Participants
|
2 participants
n=107 Participants
|
2 participants
n=206 Participants
|
2 participants
n=7 Participants
|
9 participants
n=31 Participants
|
|
Anemia
No
|
30 participants
n=99 Participants
|
32 participants
n=107 Participants
|
51 participants
n=206 Participants
|
44 participants
n=7 Participants
|
157 participants
n=31 Participants
|
|
Stroke
Yes
|
3 participants
n=99 Participants
|
1 participants
n=107 Participants
|
2 participants
n=206 Participants
|
2 participants
n=7 Participants
|
8 participants
n=31 Participants
|
|
Stroke
No
|
30 participants
n=99 Participants
|
33 participants
n=107 Participants
|
51 participants
n=206 Participants
|
44 participants
n=7 Participants
|
158 participants
n=31 Participants
|
|
Myocardial disease
Yes
|
1 participants
n=99 Participants
|
0 participants
n=107 Participants
|
2 participants
n=206 Participants
|
2 participants
n=7 Participants
|
5 participants
n=31 Participants
|
|
Myocardial disease
No
|
32 participants
n=99 Participants
|
34 participants
n=107 Participants
|
51 participants
n=206 Participants
|
44 participants
n=7 Participants
|
161 participants
n=31 Participants
|
|
Chronic respiratory insuficiency
Yes
|
6 participants
n=99 Participants
|
0 participants
n=107 Participants
|
1 participants
n=206 Participants
|
0 participants
n=7 Participants
|
7 participants
n=31 Participants
|
|
Chronic respiratory insuficiency
No
|
27 participants
n=99 Participants
|
34 participants
n=107 Participants
|
52 participants
n=206 Participants
|
46 participants
n=7 Participants
|
159 participants
n=31 Participants
|
|
Surgical procedure
Right hemicolectomy
|
7 participants
n=99 Participants
|
5 participants
n=107 Participants
|
0 participants
n=206 Participants
|
0 participants
n=7 Participants
|
12 participants
n=31 Participants
|
|
Surgical procedure
Left hemicolectomy
|
14 participants
n=99 Participants
|
15 participants
n=107 Participants
|
0 participants
n=206 Participants
|
0 participants
n=7 Participants
|
29 participants
n=31 Participants
|
|
Surgical procedure
Total colectomy
|
1 participants
n=99 Participants
|
4 participants
n=107 Participants
|
0 participants
n=206 Participants
|
0 participants
n=7 Participants
|
5 participants
n=31 Participants
|
|
Surgical procedure
Rectal resections
|
11 participants
n=99 Participants
|
10 participants
n=107 Participants
|
0 participants
n=206 Participants
|
0 participants
n=7 Participants
|
21 participants
n=31 Participants
|
|
Surgical procedure
mayor hepatectomy
|
0 participants
n=99 Participants
|
0 participants
n=107 Participants
|
22 participants
n=206 Participants
|
17 participants
n=7 Participants
|
39 participants
n=31 Participants
|
|
Surgical procedure
minor hepatectomy
|
0 participants
n=99 Participants
|
0 participants
n=107 Participants
|
30 participants
n=206 Participants
|
29 participants
n=7 Participants
|
59 participants
n=31 Participants
|
|
Surgical procedure
radiofrequency
|
0 participants
n=99 Participants
|
0 participants
n=107 Participants
|
1 participants
n=206 Participants
|
0 participants
n=7 Participants
|
1 participants
n=31 Participants
|
|
Duration of surgery
|
205 minutes
n=99 Participants
|
225 minutes
n=107 Participants
|
274.26 minutes
n=206 Participants
|
263.57 minutes
n=7 Participants
|
241.95 minutes
n=31 Participants
|
|
Size of incision
|
16.5 cm
n=99 Participants
|
17.5 cm
n=107 Participants
|
31.5 cm
n=206 Participants
|
29.67 cm
n=7 Participants
|
23.79 cm
n=31 Participants
|
PRIMARY outcome
Timeframe: 48 hoursOutcome measures
| Measure |
Ropivacaine Colorectal Surgery
n=29 Participants
After a bolus administration of Ropivacaine a perfusion ot the same anesthetic is initiated through an elastomeric wound during 48 hours
ropivacaine: Laparotomy of colorectal surgery: 10 ml bolus ropivacaine 0,75% + infusion with elastomeric pump with ropivacaine 0,38% at a 5ml/h.
Laparoscopy of colorectal surgery: 5 ml bolus ropivacaine 0,75% + infusion with elastomeric pump with ropivacaine 0,38% at a 2 ml/h.
|
Saline Solution Colorectal Surgery
n=31 Participants
After a bolus administration of saline solution a perfusion ot saline solution is initiated through an elastomeric wound during 48 hours
placebo: Laparotomy of colorectal surgery: 10 ml bolus saline solution 0.9% + infusion with elastomeric pump with saline solution 0.9% at a 5ml/h.
Laparoscopy of colorectal surgery: 10 ml bolus saline solution 0.9% + infusion with elastomeric pump with saline solution 0.9% at a 2 ml/h.
|
Ropivacaine Hepatic Surgery
n=52 Participants
After a bolus administration of Ropivacaine a perfusion ot the same anesthetic is initiated through an elastomeric wound during 48 hours Hepatic surgery: 10 ml of ropivacaine 0,45% + infusion with elastomeric pump with ropivacaine 0,23 at a 5ml/h.
|
Saline Solution Hepatic Surgery
n=44 Participants
After a bolus administration of saline solution a perfusion ot saline solution is initiated through an elastomeric wound during 48 hours Hepatic surgery: 10 ml de saline solution 0.9% + infusion with elastomeric pump with saline solution 0.9% at a 5ml/h
|
|---|---|---|---|---|
|
Mg of Morphine Consumption During 48 Hours Administered by Patient Controlled Analgesia System
|
23 mg
Interval 11.25 to 42.75
|
52 mg
Interval 24.5 to 64.0
|
24.63 mg
Interval 19.97 to 29.29
|
26.78 mg
Interval 21.7 to 31.85
|
SECONDARY outcome
Timeframe: At interval periods during 48 hoursVerbal pain scale is a numeric measure of intensity pain, values range from 0 (no pain) to 10 (excruciating pain), Each patient rate the paín that feel with a number from 0 to 10.
Outcome measures
| Measure |
Ropivacaine Colorectal Surgery
n=33 Participants
After a bolus administration of Ropivacaine a perfusion ot the same anesthetic is initiated through an elastomeric wound during 48 hours
ropivacaine: Laparotomy of colorectal surgery: 10 ml bolus ropivacaine 0,75% + infusion with elastomeric pump with ropivacaine 0,38% at a 5ml/h.
Laparoscopy of colorectal surgery: 5 ml bolus ropivacaine 0,75% + infusion with elastomeric pump with ropivacaine 0,38% at a 2 ml/h.
|
Saline Solution Colorectal Surgery
n=34 Participants
After a bolus administration of saline solution a perfusion ot saline solution is initiated through an elastomeric wound during 48 hours
placebo: Laparotomy of colorectal surgery: 10 ml bolus saline solution 0.9% + infusion with elastomeric pump with saline solution 0.9% at a 5ml/h.
Laparoscopy of colorectal surgery: 10 ml bolus saline solution 0.9% + infusion with elastomeric pump with saline solution 0.9% at a 2 ml/h.
|
Ropivacaine Hepatic Surgery
n=53 Participants
After a bolus administration of Ropivacaine a perfusion ot the same anesthetic is initiated through an elastomeric wound during 48 hours Hepatic surgery: 10 ml of ropivacaine 0,45% + infusion with elastomeric pump with ropivacaine 0,23 at a 5ml/h.
|
Saline Solution Hepatic Surgery
n=46 Participants
After a bolus administration of saline solution a perfusion ot saline solution is initiated through an elastomeric wound during 48 hours Hepatic surgery: 10 ml de saline solution 0.9% + infusion with elastomeric pump with saline solution 0.9% at a 5ml/h
|
|---|---|---|---|---|
|
Intensity of Pain Measured by Verbal Pain Scale.
Verbal numeric scale 0h after surgery
|
1 units on a scale
Interval 0.0 to 3.0
|
2.5 units on a scale
Interval 0.0 to 6.5
|
2.75 units on a scale
Interval 1.94 to 3.57
|
2.5 units on a scale
Interval 1.63 to 3.37
|
|
Intensity of Pain Measured by Verbal Pain Scale.
Verbal numeric scale 6h after surgery
|
2 units on a scale
Interval 1.0 to 3.0
|
3 units on a scale
Interval 1.0 to 4.0
|
1.72 units on a scale
Interval 1.33 to 2.1
|
2.38 units on a scale
Interval 1.81 to 2.95
|
|
Intensity of Pain Measured by Verbal Pain Scale.
Verbal numeric scale 12h after surgery
|
2 units on a scale
Interval 1.0 to 3.0
|
2 units on a scale
Interval 1.0 to 2.75
|
1.45 units on a scale
Interval 1.09 to 1.81
|
1.8 units on a scale
Interval 1.22 to 2.38
|
|
Intensity of Pain Measured by Verbal Pain Scale.
Verbal numeric scale 24h after surgery
|
2 units on a scale
Interval 2.0 to 3.0
|
2 units on a scale
Interval 1.0 to 3.0
|
1.64 units on a scale
Interval 1.32 to 1.96
|
2 units on a scale
Interval 1.44 to 2.56
|
|
Intensity of Pain Measured by Verbal Pain Scale.
Verbal numeric scale 48h after surgery
|
2 units on a scale
Interval 1.0 to 3.0
|
2 units on a scale
Interval 1.0 to 2.0
|
1.62 units on a scale
Interval 1.29 to 1.94
|
2.14 units on a scale
Interval 1.59 to 2.68
|
SECONDARY outcome
Timeframe: 7 Days (from Day 8-15)Outcome measures
| Measure |
Ropivacaine Colorectal Surgery
n=33 Participants
After a bolus administration of Ropivacaine a perfusion ot the same anesthetic is initiated through an elastomeric wound during 48 hours
ropivacaine: Laparotomy of colorectal surgery: 10 ml bolus ropivacaine 0,75% + infusion with elastomeric pump with ropivacaine 0,38% at a 5ml/h.
Laparoscopy of colorectal surgery: 5 ml bolus ropivacaine 0,75% + infusion with elastomeric pump with ropivacaine 0,38% at a 2 ml/h.
|
Saline Solution Colorectal Surgery
n=34 Participants
After a bolus administration of saline solution a perfusion ot saline solution is initiated through an elastomeric wound during 48 hours
placebo: Laparotomy of colorectal surgery: 10 ml bolus saline solution 0.9% + infusion with elastomeric pump with saline solution 0.9% at a 5ml/h.
Laparoscopy of colorectal surgery: 10 ml bolus saline solution 0.9% + infusion with elastomeric pump with saline solution 0.9% at a 2 ml/h.
|
Ropivacaine Hepatic Surgery
n=53 Participants
After a bolus administration of Ropivacaine a perfusion ot the same anesthetic is initiated through an elastomeric wound during 48 hours Hepatic surgery: 10 ml of ropivacaine 0,45% + infusion with elastomeric pump with ropivacaine 0,23 at a 5ml/h.
|
Saline Solution Hepatic Surgery
n=46 Participants
After a bolus administration of saline solution a perfusion ot saline solution is initiated through an elastomeric wound during 48 hours Hepatic surgery: 10 ml de saline solution 0.9% + infusion with elastomeric pump with saline solution 0.9% at a 5ml/h
|
|---|---|---|---|---|
|
Time Spent Sitting in a Chair, Deambulation, Solid Ingestion.
Sitting in the chair
|
46 hours
Interval 24.0 to 48.0
|
48 hours
Interval 42.0 to 48.0
|
51.75 hours
Interval 45.5 to 58.0
|
43.2 hours
Interval 38.25 to 48.14
|
|
Time Spent Sitting in a Chair, Deambulation, Solid Ingestion.
Deambulation
|
72 hours
Interval 48.0 to 104.0
|
72 hours
Interval 69.0 to 96.0
|
81.2 hours
Interval 73.71 to 88.69
|
87.37 hours
Interval 70.97 to 103.77
|
|
Time Spent Sitting in a Chair, Deambulation, Solid Ingestion.
Solid food intake
|
96 hours
Interval 72.0 to 120.0
|
120 hours
Interval 72.0 to 158.0
|
88 hours
Interval 79.8 to 96.19
|
79.79 hours
Interval 64.25 to 95.34
|
SECONDARY outcome
Timeframe: during 48 hoursOutcome measures
| Measure |
Ropivacaine Colorectal Surgery
n=33 Participants
After a bolus administration of Ropivacaine a perfusion ot the same anesthetic is initiated through an elastomeric wound during 48 hours
ropivacaine: Laparotomy of colorectal surgery: 10 ml bolus ropivacaine 0,75% + infusion with elastomeric pump with ropivacaine 0,38% at a 5ml/h.
Laparoscopy of colorectal surgery: 5 ml bolus ropivacaine 0,75% + infusion with elastomeric pump with ropivacaine 0,38% at a 2 ml/h.
|
Saline Solution Colorectal Surgery
n=34 Participants
After a bolus administration of saline solution a perfusion ot saline solution is initiated through an elastomeric wound during 48 hours
placebo: Laparotomy of colorectal surgery: 10 ml bolus saline solution 0.9% + infusion with elastomeric pump with saline solution 0.9% at a 5ml/h.
Laparoscopy of colorectal surgery: 10 ml bolus saline solution 0.9% + infusion with elastomeric pump with saline solution 0.9% at a 2 ml/h.
|
Ropivacaine Hepatic Surgery
n=53 Participants
After a bolus administration of Ropivacaine a perfusion ot the same anesthetic is initiated through an elastomeric wound during 48 hours Hepatic surgery: 10 ml of ropivacaine 0,45% + infusion with elastomeric pump with ropivacaine 0,23 at a 5ml/h.
|
Saline Solution Hepatic Surgery
n=46 Participants
After a bolus administration of saline solution a perfusion ot saline solution is initiated through an elastomeric wound during 48 hours Hepatic surgery: 10 ml de saline solution 0.9% + infusion with elastomeric pump with saline solution 0.9% at a 5ml/h
|
|---|---|---|---|---|
|
Secondary Effects Due to Morphine: Nausea and Vomiting
Yes
|
5 participants
|
6 participants
|
2 participants
|
6 participants
|
|
Secondary Effects Due to Morphine: Nausea and Vomiting
No
|
28 participants
|
28 participants
|
51 participants
|
40 participants
|
SECONDARY outcome
Timeframe: During 8-15 daysOutcome measures
| Measure |
Ropivacaine Colorectal Surgery
n=33 Participants
After a bolus administration of Ropivacaine a perfusion ot the same anesthetic is initiated through an elastomeric wound during 48 hours
ropivacaine: Laparotomy of colorectal surgery: 10 ml bolus ropivacaine 0,75% + infusion with elastomeric pump with ropivacaine 0,38% at a 5ml/h.
Laparoscopy of colorectal surgery: 5 ml bolus ropivacaine 0,75% + infusion with elastomeric pump with ropivacaine 0,38% at a 2 ml/h.
|
Saline Solution Colorectal Surgery
n=34 Participants
After a bolus administration of saline solution a perfusion ot saline solution is initiated through an elastomeric wound during 48 hours
placebo: Laparotomy of colorectal surgery: 10 ml bolus saline solution 0.9% + infusion with elastomeric pump with saline solution 0.9% at a 5ml/h.
Laparoscopy of colorectal surgery: 10 ml bolus saline solution 0.9% + infusion with elastomeric pump with saline solution 0.9% at a 2 ml/h.
|
Ropivacaine Hepatic Surgery
n=53 Participants
After a bolus administration of Ropivacaine a perfusion ot the same anesthetic is initiated through an elastomeric wound during 48 hours Hepatic surgery: 10 ml of ropivacaine 0,45% + infusion with elastomeric pump with ropivacaine 0,23 at a 5ml/h.
|
Saline Solution Hepatic Surgery
n=46 Participants
After a bolus administration of saline solution a perfusion ot saline solution is initiated through an elastomeric wound during 48 hours Hepatic surgery: 10 ml de saline solution 0.9% + infusion with elastomeric pump with saline solution 0.9% at a 5ml/h
|
|---|---|---|---|---|
|
Local Reaction in the Wound and Insertion Point of the Catheter (Inflammation Signs and Infection)
No
|
27 participants
|
24 participants
|
51 participants
|
44 participants
|
|
Local Reaction in the Wound and Insertion Point of the Catheter (Inflammation Signs and Infection)
Yes
|
6 participants
|
10 participants
|
2 participants
|
2 participants
|
SECONDARY outcome
Timeframe: at 48 hoursOutcome measures
| Measure |
Ropivacaine Colorectal Surgery
n=33 Participants
After a bolus administration of Ropivacaine a perfusion ot the same anesthetic is initiated through an elastomeric wound during 48 hours
ropivacaine: Laparotomy of colorectal surgery: 10 ml bolus ropivacaine 0,75% + infusion with elastomeric pump with ropivacaine 0,38% at a 5ml/h.
Laparoscopy of colorectal surgery: 5 ml bolus ropivacaine 0,75% + infusion with elastomeric pump with ropivacaine 0,38% at a 2 ml/h.
|
Saline Solution Colorectal Surgery
n=34 Participants
After a bolus administration of saline solution a perfusion ot saline solution is initiated through an elastomeric wound during 48 hours
placebo: Laparotomy of colorectal surgery: 10 ml bolus saline solution 0.9% + infusion with elastomeric pump with saline solution 0.9% at a 5ml/h.
Laparoscopy of colorectal surgery: 10 ml bolus saline solution 0.9% + infusion with elastomeric pump with saline solution 0.9% at a 2 ml/h.
|
Ropivacaine Hepatic Surgery
n=53 Participants
After a bolus administration of Ropivacaine a perfusion ot the same anesthetic is initiated through an elastomeric wound during 48 hours Hepatic surgery: 10 ml of ropivacaine 0,45% + infusion with elastomeric pump with ropivacaine 0,23 at a 5ml/h.
|
Saline Solution Hepatic Surgery
n=46 Participants
After a bolus administration of saline solution a perfusion ot saline solution is initiated through an elastomeric wound during 48 hours Hepatic surgery: 10 ml de saline solution 0.9% + infusion with elastomeric pump with saline solution 0.9% at a 5ml/h
|
|---|---|---|---|---|
|
Contamination of the Catheter (Microbiologist Analysis)
Yes
|
6 participants
|
4 participants
|
2 participants
|
2 participants
|
|
Contamination of the Catheter (Microbiologist Analysis)
No
|
27 participants
|
30 participants
|
51 participants
|
44 participants
|
Adverse Events
Ropivacaine Colorectal Surgery
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Saline Solution Colorectal Surgery
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Ropivacaine Hepatic Surgery
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Saline Solution Hepatic Surgery
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Noelia Fustran
Department of Anesthesia, Reanimation Bellvitge University Hospital
Phone: 932607323
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place