Trial Outcomes & Findings for Clinical Trial of the Use of Intraperitoneal Local Anaesthetic (NCT NCT00180687)
NCT ID: NCT00180687
Last Updated: 2015-09-15
Results Overview
Postoperative pain was measured using Pain scale 0-10 (0 = No Pain, 10 = Maximum pain). A trained nursing staff will ask the patient about his / her pain and document that correctly in the chart. The staff will also document if the patient requires any analgesia, the type and the dose.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
80 participants
Primary outcome timeframe
0 hours, 6 hours, 12 hours, 24 hours
Results posted on
2015-09-15
Participant Flow
Participant milestones
| Measure |
Control
No intraperitoneal therapeutics (No nebulised Bupivacaine)
No Intraperitoneal Therapeutics: No Intraperitoneal Therapeutics given
|
IP Aerosolized Normal Saline
Intraperitoneal nebulised 10mls. Normal Saline (No nebulised Bupivacaine)
Normal Saline: Nebulised Normal Saline
|
Nebulised Bupivacaine Intraperitoneally
Intraperitoneal Nebulised 10mls. Bupivacaione (Marcaine)
Nebulised Bupivacaine intraperitoneally: Nebulised Marcaine (Bupivacaine)
|
Injected Bupivacaine Intraperitoneally
Intraperitoeal Injected 10 mls.Bupivacaine (Marcaine) (No nebulised Bupivacaine)
Injected Bupivacaine intraperitoneally: Injected Marcaine directly into the peritoneal cavity
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
20
|
20
|
|
Overall Study
COMPLETED
|
20
|
20
|
20
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Clinical Trial of the Use of Intraperitoneal Local Anaesthetic
Baseline characteristics by cohort
| Measure |
Control
n=20 Participants
No intraperitoneal therapeutics (No nebulised Bupivacaine)
No Intraperitoneal Therapeutics: No Intraperitoneal Therapeutics given
|
IP Aerosolized Normal Saline
n=20 Participants
Intraperitoneal nebulised 10mls. Normal Saline (No nebulised Bupivacaine)
Normal Saline: Nebulised Normal Saline
|
Nebulised Bupivacaine Intraperitoneally
n=20 Participants
Intraperitoneal Nebulised 10mls. Bupivacaione (Marcaine)
Nebulised Bupivacaine intraperitoneally: Nebulised Marcaine (Bupivacaine)
|
Injected Bupivacaine Intraperitoneally
n=20 Participants
Intraperitoeal Injected 10 mls.Bupivacaine (Marcaine) (No nebulised Bupivacaine)
Injected Bupivacaine intraperitoneally: Injected Marcaine directly into the peritoneal cavity
|
Total
n=80 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
47.65 Years
n=5 Participants
|
47.65 Years
n=7 Participants
|
51.60 Years
n=5 Participants
|
48.70 Years
n=4 Participants
|
49 Years
n=21 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
69 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
|
Region of Enrollment
United Kingdom
|
20 participants
n=5 Participants
|
20 participants
n=7 Participants
|
20 participants
n=5 Participants
|
20 participants
n=4 Participants
|
80 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 0 hours, 6 hours, 12 hours, 24 hoursPostoperative pain was measured using Pain scale 0-10 (0 = No Pain, 10 = Maximum pain). A trained nursing staff will ask the patient about his / her pain and document that correctly in the chart. The staff will also document if the patient requires any analgesia, the type and the dose.
Outcome measures
| Measure |
Control
n=20 Participants
No intraperitoneal therapeutics (No nebulised Bupivacaine)
No Intraperitoneal Therapeutics: No Intraperitoneal Therapeutics given
|
IP Aerosolized Normal Saline
n=20 Participants
Intraperitoneal nebulised 10mls. Normal Saline (No nebulised Bupivacaine)
Normal Saline: Nebulised Normal Saline
|
Nebulised Bupivacaine Intraperitoneally
n=20 Participants
Intraperitoneal Nebulised 10mls. Bupivacaione (Marcaine)
Nebulised Bupivacaine intraperitoneally: Nebulised Marcaine (Bupivacaine)
|
Injected Bupivacaine Intraperitoneally
n=20 Participants
Intraperitoeal Injected 10 mls.Bupivacaine (Marcaine) (No nebulised Bupivacaine)
Injected Bupivacaine intraperitoneally: Injected Marcaine directly into the peritoneal cavity
|
|---|---|---|---|---|
|
Reduction in Postoperative Pain
Pain in Recovery (0 Hours)
|
9.2 units on a scale
Interval 3.0 to 10.0
|
10 units on a scale
Interval 10.0 to 10.0
|
3.3 units on a scale
Interval 1.0 to 10.0
|
9.3 units on a scale
Interval 5.0 to 10.0
|
|
Reduction in Postoperative Pain
Pain at 6 hours
|
8.2 units on a scale
Interval 5.0 to 10.0
|
8.1 units on a scale
Interval 4.0 to 10.0
|
0.7 units on a scale
Interval 0.0 to 3.0
|
7.2 units on a scale
Interval 4.0 to 10.0
|
|
Reduction in Postoperative Pain
Pain at 12 hours
|
7.9 units on a scale
Interval 3.0 to 10.0
|
8 units on a scale
Interval 4.0 to 10.0
|
0.6 units on a scale
Interval 0.0 to 3.0
|
6.7 units on a scale
Interval 4.0 to 10.0
|
|
Reduction in Postoperative Pain
Pain at 24 hours
|
6.1 units on a scale
Interval 4.0 to 10.0
|
6.2 units on a scale
Interval 2.0 to 10.0
|
0.5 units on a scale
Interval 0.0 to 3.0
|
5.6 units on a scale
Interval 3.0 to 8.0
|
SECONDARY outcome
Timeframe: 24 hoursNausea and vomiting are known adverse effect of opioids usage. By reducing the use of opioids we can reduce or abolish these side effect which will enhance early patient recovery and discharge and reduce hospital cost. We will measure the number of episodes when the patient suffers from these side effect and correlate them with opioids use.
Outcome measures
| Measure |
Control
n=20 Participants
No intraperitoneal therapeutics (No nebulised Bupivacaine)
No Intraperitoneal Therapeutics: No Intraperitoneal Therapeutics given
|
IP Aerosolized Normal Saline
n=20 Participants
Intraperitoneal nebulised 10mls. Normal Saline (No nebulised Bupivacaine)
Normal Saline: Nebulised Normal Saline
|
Nebulised Bupivacaine Intraperitoneally
n=20 Participants
Intraperitoneal Nebulised 10mls. Bupivacaione (Marcaine)
Nebulised Bupivacaine intraperitoneally: Nebulised Marcaine (Bupivacaine)
|
Injected Bupivacaine Intraperitoneally
n=20 Participants
Intraperitoeal Injected 10 mls.Bupivacaine (Marcaine) (No nebulised Bupivacaine)
Injected Bupivacaine intraperitoneally: Injected Marcaine directly into the peritoneal cavity
|
|---|---|---|---|---|
|
Number of Vomiting / Nausea Episodes
|
7.1 Number of vomitting / Nausea episodes
Interval 5.0 to 9.0
|
7.1 Number of vomitting / Nausea episodes
Interval 3.0 to 8.0
|
2 Number of vomitting / Nausea episodes
Interval 0.0 to 4.0
|
6.8 Number of vomitting / Nausea episodes
Interval 2.0 to 9.0
|
SECONDARY outcome
Timeframe: 24 HoursDrowsiness and delayed mobilization are known adverse effect of opioids usage. By reducing the use of opioids we can reduce or abolish these side effect which will enhance early patient recovery and discharge and reduce hospital cost. We will measure how many hours will take the patient to mobilize freely and safely and correlate them with opioids use.
Outcome measures
| Measure |
Control
n=20 Participants
No intraperitoneal therapeutics (No nebulised Bupivacaine)
No Intraperitoneal Therapeutics: No Intraperitoneal Therapeutics given
|
IP Aerosolized Normal Saline
n=20 Participants
Intraperitoneal nebulised 10mls. Normal Saline (No nebulised Bupivacaine)
Normal Saline: Nebulised Normal Saline
|
Nebulised Bupivacaine Intraperitoneally
n=20 Participants
Intraperitoneal Nebulised 10mls. Bupivacaione (Marcaine)
Nebulised Bupivacaine intraperitoneally: Nebulised Marcaine (Bupivacaine)
|
Injected Bupivacaine Intraperitoneally
n=20 Participants
Intraperitoeal Injected 10 mls.Bupivacaine (Marcaine) (No nebulised Bupivacaine)
Injected Bupivacaine intraperitoneally: Injected Marcaine directly into the peritoneal cavity
|
|---|---|---|---|---|
|
Hours Needed for Safe Mobilization
|
6.7 Hours needed for safe mobilization
Interval 4.0 to 10.0
|
6.5 Hours needed for safe mobilization
Interval 4.0 to 11.0
|
3 Hours needed for safe mobilization
Interval 2.0 to 4.0
|
6.4 Hours needed for safe mobilization
Interval 3.0 to 9.0
|
SECONDARY outcome
Timeframe: 24 HoiursThe reduction in cost comes from reducing the use of opioid which requires nursing supervision and also special pump to be delivered as in the cases of patient controlled analgesia. With that reduction, there will be a reduction in opioid related adverse events that mandate medical or nursing attention and prolong hospitalization, these adverse events include nausea and vomiting, delay mobilization due to drowsiness and alter mental status caused by opioid usage. For these reasons we are collecting data related to these adverse events
Outcome measures
| Measure |
Control
n=20 Participants
No intraperitoneal therapeutics (No nebulised Bupivacaine)
No Intraperitoneal Therapeutics: No Intraperitoneal Therapeutics given
|
IP Aerosolized Normal Saline
n=20 Participants
Intraperitoneal nebulised 10mls. Normal Saline (No nebulised Bupivacaine)
Normal Saline: Nebulised Normal Saline
|
Nebulised Bupivacaine Intraperitoneally
n=20 Participants
Intraperitoneal Nebulised 10mls. Bupivacaione (Marcaine)
Nebulised Bupivacaine intraperitoneally: Nebulised Marcaine (Bupivacaine)
|
Injected Bupivacaine Intraperitoneally
n=20 Participants
Intraperitoeal Injected 10 mls.Bupivacaine (Marcaine) (No nebulised Bupivacaine)
Injected Bupivacaine intraperitoneally: Injected Marcaine directly into the peritoneal cavity
|
|---|---|---|---|---|
|
Postoperative Morphine Use
|
25.9 mg
Interval 10.0 to 45.0
|
26.3 mg
Interval 10.0 to 50.0
|
1 mg
Interval 0.0 to 10.0
|
16.7 mg
Interval 8.0 to 30.0
|
Adverse Events
Control
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
IP Aerosolized Normal Saline
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Nebulised Bupivacaine Intraperitoneally
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Injected Bupivacaine Intraperitoneally
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Control
n=20 participants at risk
No intraperitoneal therapeutics (No nebulised Bupivacaine)
No Intraperitoneal Therapeutics: No Intraperitoneal Therapeutics given
|
IP Aerosolized Normal Saline
n=20 participants at risk
Intraperitoneal nebulised 10mls. Normal Saline (No nebulised Bupivacaine)
Normal Saline: Nebulised Normal Saline
|
Nebulised Bupivacaine Intraperitoneally
n=20 participants at risk
Intraperitoneal Nebulised 10mls. Bupivacaione (Marcaine)
Nebulised Bupivacaine intraperitoneally: Nebulised Marcaine (Bupivacaine)
|
Injected Bupivacaine Intraperitoneally
n=20 participants at risk
Intraperitoeal Injected 10 mls.Bupivacaine (Marcaine) (No nebulised Bupivacaine)
Injected Bupivacaine intraperitoneally: Injected Marcaine directly into the peritoneal cavity
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea and Vomiting
|
25.0%
5/20 • Number of events 9 • 24 Hours
Nausea and Vomiting
|
25.0%
5/20 • Number of events 8 • 24 Hours
Nausea and Vomiting
|
5.0%
1/20 • Number of events 4 • 24 Hours
Nausea and Vomiting
|
25.0%
5/20 • Number of events 9 • 24 Hours
Nausea and Vomiting
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place