Trial Outcomes & Findings for Safety and Efficacy of the Addition of Morphine Chloride to a Low Dose of Bupivacaine as Intradural Anaesthetic for the Removal Surgery of the Hemorrhoids (NCT NCT02046772)
NCT ID: NCT02046772
Last Updated: 2016-08-15
Results Overview
To compare whether the addition of morphine chloride to a low dose intradural solution of the local anaesthetic bupivacaine is as effective as an administration of a single dose of bupivacaine.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
63 participants
Primary outcome timeframe
First 20 minutes between administration and beginning of surgery
Results posted on
2016-08-15
Participant Flow
Participant milestones
| Measure |
Bupivacaine + Morphine Chloride
People in this arm will receive treatment with morphine chloride (50 mcgr) in addition to a low dose solution of the local intradural anaesthetic bupivacaine (3mg).
Bupivacaine low dose: A dose of morphine chloride added to a low dose solution of bupivacaine administered intradural.
Morphine Chloride: A dose of morphine chloride added to a low dose solution of bupivacaine administered intradural.
|
Bupivacaine Standard Dose
People in this arm will receive treatment with the standard dose of the local intradural anaesthetic bupivacaine (5mg).
Bupivacaine standard dose: Single intradural standard dose of bupivacaine.
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
33
|
|
Overall Study
COMPLETED
|
30
|
33
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Efficacy of the Addition of Morphine Chloride to a Low Dose of Bupivacaine as Intradural Anaesthetic for the Removal Surgery of the Hemorrhoids
Baseline characteristics by cohort
| Measure |
Bupivacaine + Morphine Chloride
n=30 Participants
People in this arm will receive treatment with morphine chloride (50 mcgr) in addition to a low dose solution of the local intradural anaesthetic bupivacaine (3mg).
Bupivacaine low dose: A dose of morphine chloride added to a low dose solution of bupivacaine administered intradural.
Morphine Chloride: A dose of morphine chloride added to a low dose solution of bupivacaine administered intradural.
|
Bupivacaine Standard Dose
n=33 Participants
People in this arm will receive treatment with the standard dose of the local intradural anaesthetic bupivacaine (5mg).
Bupivacaine standard dose: Single intradural standard dose of bupivacaine.
|
Total
n=63 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
45.8 years
STANDARD_DEVIATION 10.5 • n=5 Participants
|
51.3 years
STANDARD_DEVIATION 10.8 • n=7 Participants
|
48.7 years
STANDARD_DEVIATION 10.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
30 participants
n=5 Participants
|
33 participants
n=7 Participants
|
63 participants
n=5 Participants
|
|
BMI
|
25.1 Kg*m^-2
STANDARD_DEVIATION 3.3 • n=5 Participants
|
27.2 Kg*m^-2
STANDARD_DEVIATION 4 • n=7 Participants
|
26.2 Kg*m^-2
STANDARD_DEVIATION 3.9 • n=5 Participants
|
|
ASA
ASA I
|
7 participants
n=5 Participants
|
8 participants
n=7 Participants
|
15 participants
n=5 Participants
|
|
ASA
ASA II
|
22 participants
n=5 Participants
|
25 participants
n=7 Participants
|
47 participants
n=5 Participants
|
|
ASA
ASA III
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Number of haemorrhoidal packs removed
1 haemorrhoidal pack
|
8 participants
n=5 Participants
|
12 participants
n=7 Participants
|
20 participants
n=5 Participants
|
|
Number of haemorrhoidal packs removed
2 haemorrhoidal packs
|
12 participants
n=5 Participants
|
13 participants
n=7 Participants
|
25 participants
n=5 Participants
|
|
Number of haemorrhoidal packs removed
3 haemorrhoidal packs
|
8 participants
n=5 Participants
|
8 participants
n=7 Participants
|
16 participants
n=5 Participants
|
|
Number of haemorrhoidal packs removed
Unavailable
|
2 participants
n=5 Participants
|
0 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Need of pre-surgery sedation
Yes
|
23 participants
n=5 Participants
|
23 participants
n=7 Participants
|
46 participants
n=5 Participants
|
|
Need of pre-surgery sedation
No
|
7 participants
n=5 Participants
|
10 participants
n=7 Participants
|
17 participants
n=5 Participants
|
|
Duration of surgery
|
28 minutes
STANDARD_DEVIATION 11.1 • n=5 Participants
|
20.4 minutes
STANDARD_DEVIATION 9.2 • n=7 Participants
|
24 minutes
STANDARD_DEVIATION 10.8 • n=5 Participants
|
PRIMARY outcome
Timeframe: First 20 minutes between administration and beginning of surgeryTo compare whether the addition of morphine chloride to a low dose intradural solution of the local anaesthetic bupivacaine is as effective as an administration of a single dose of bupivacaine.
Outcome measures
| Measure |
Bupivacaine + Morphine Chloride
n=30 Participants
People in this arm will receive treatment with morphine chloride (50 mcgr) in addition to a low dose solution of the local intradural anaesthetic bupivacaine (3mg).
Bupivacaine low dose: A dose of morphine chloride added to a low dose solution of bupivacaine administered intradural.
Morphine Chloride: A dose of morphine chloride added to a low dose solution of bupivacaine administered intradural.
|
Bupivacaine Standard Dose
n=33 Participants
People in this arm will receive treatment with the standard dose of the local intradural anaesthetic bupivacaine (5mg).
Bupivacaine standard dose: Single intradural standard dose of bupivacaine.
|
|---|---|---|
|
Measurement of Time to Start the Anaesthetic Effect
Time to sensitive blocking
|
2.1 minutes
Standard Deviation 1.8
|
1.6 minutes
Standard Deviation 1.5
|
|
Measurement of Time to Start the Anaesthetic Effect
Time to motor blocking
|
7.7 minutes
Standard Deviation 5.9
|
4.7 minutes
Standard Deviation 3.3
|
PRIMARY outcome
Timeframe: Up to 72 hours from the end of the surgery in the hospital stay and during the next 7 days at home, after dischargeTo compare whether the addition of morphine chloride to a low dose solution of bupivacaine and improves the analgesic treatment than a single administration of bupivacaine.
Outcome measures
| Measure |
Bupivacaine + Morphine Chloride
n=30 Participants
People in this arm will receive treatment with morphine chloride (50 mcgr) in addition to a low dose solution of the local intradural anaesthetic bupivacaine (3mg).
Bupivacaine low dose: A dose of morphine chloride added to a low dose solution of bupivacaine administered intradural.
Morphine Chloride: A dose of morphine chloride added to a low dose solution of bupivacaine administered intradural.
|
Bupivacaine Standard Dose
n=33 Participants
People in this arm will receive treatment with the standard dose of the local intradural anaesthetic bupivacaine (5mg).
Bupivacaine standard dose: Single intradural standard dose of bupivacaine.
|
|---|---|---|
|
Measurement of the Analgesic Effect After Surgery by VAS From 0 to 10, Where 0 is no Pain and 10 is the Worst Pain Imaginable.
VAS at the enter in the reanimation unit
|
0.03 units on a scale
Standard Deviation 0.1
|
0.15 units on a scale
Standard Deviation 0.7
|
|
Measurement of the Analgesic Effect After Surgery by VAS From 0 to 10, Where 0 is no Pain and 10 is the Worst Pain Imaginable.
VAS after 10 minutes in reanimation unit
|
0 units on a scale
Standard Deviation 0
|
0.3 units on a scale
Standard Deviation 1
|
|
Measurement of the Analgesic Effect After Surgery by VAS From 0 to 10, Where 0 is no Pain and 10 is the Worst Pain Imaginable.
VAS after 30 minutes in reanimation unit
|
0.06 units on a scale
Standard Deviation 0.3
|
0.72 units on a scale
Standard Deviation 1.5
|
|
Measurement of the Analgesic Effect After Surgery by VAS From 0 to 10, Where 0 is no Pain and 10 is the Worst Pain Imaginable.
VAS day 1 after surgery
|
1.5 units on a scale
Standard Deviation 1.2
|
3.3 units on a scale
Standard Deviation 2.2
|
|
Measurement of the Analgesic Effect After Surgery by VAS From 0 to 10, Where 0 is no Pain and 10 is the Worst Pain Imaginable.
VAS day 2 after surgery
|
3.8 units on a scale
Standard Deviation 2.8
|
4 units on a scale
Standard Deviation 2.5
|
|
Measurement of the Analgesic Effect After Surgery by VAS From 0 to 10, Where 0 is no Pain and 10 is the Worst Pain Imaginable.
VAS day 3 after surgery
|
3.7 units on a scale
Standard Deviation 2.7
|
4.5 units on a scale
Standard Deviation 2.3
|
|
Measurement of the Analgesic Effect After Surgery by VAS From 0 to 10, Where 0 is no Pain and 10 is the Worst Pain Imaginable.
VAS day 4 after surgery
|
3.6 units on a scale
Standard Deviation 2.6
|
4.4 units on a scale
Standard Deviation 2.3
|
|
Measurement of the Analgesic Effect After Surgery by VAS From 0 to 10, Where 0 is no Pain and 10 is the Worst Pain Imaginable.
VAS day 5 after surgery
|
3.6 units on a scale
Standard Deviation 2.3
|
4 units on a scale
Standard Deviation 2.2
|
|
Measurement of the Analgesic Effect After Surgery by VAS From 0 to 10, Where 0 is no Pain and 10 is the Worst Pain Imaginable.
VAS day 6 after surgery
|
3.2 units on a scale
Standard Deviation 2.6
|
3.5 units on a scale
Standard Deviation 2.3
|
|
Measurement of the Analgesic Effect After Surgery by VAS From 0 to 10, Where 0 is no Pain and 10 is the Worst Pain Imaginable.
VAS day 7 after surgery
|
2.5 units on a scale
Standard Deviation 2.3
|
3 units on a scale
Standard Deviation 2.2
|
SECONDARY outcome
Timeframe: During the first 24 hours after surgery and at the entry and exit of the resuscitation unitTo assess whether the administration of morphine chloride in addition to a low dose solution of local intradural anaesthetic (bupivacaine) improves the mobilization of the patients after surgery more than the single intradural administration of bupivacaine. Total Score in the Bromage Scale goes from 1 to 5, where: 1: complete motor blocking - 2: capable to move the feet - 3: moves the feet and bends the knee - 4: raise the leg straight more or less than 30 degrees but no against resistance - 5: raise the leg straight more than 30 degrees against resistance (no motor blocking)
Outcome measures
| Measure |
Bupivacaine + Morphine Chloride
n=30 Participants
People in this arm will receive treatment with morphine chloride (50 mcgr) in addition to a low dose solution of the local intradural anaesthetic bupivacaine (3mg).
Bupivacaine low dose: A dose of morphine chloride added to a low dose solution of bupivacaine administered intradural.
Morphine Chloride: A dose of morphine chloride added to a low dose solution of bupivacaine administered intradural.
|
Bupivacaine Standard Dose
n=33 Participants
People in this arm will receive treatment with the standard dose of the local intradural anaesthetic bupivacaine (5mg).
Bupivacaine standard dose: Single intradural standard dose of bupivacaine.
|
|---|---|---|
|
Greater and Earlier Mobilization Measured by Bromage Scale.
Bromage at the exit of surgery
|
4 units on a scale
Standard Deviation 1.3
|
3.7 units on a scale
Standard Deviation 1
|
|
Greater and Earlier Mobilization Measured by Bromage Scale.
Bromage at the enter in the reanimation unit
|
4.1 units on a scale
Standard Deviation 1.1
|
3.8 units on a scale
Standard Deviation 1
|
|
Greater and Earlier Mobilization Measured by Bromage Scale.
Bromage at the exit of the reanimation unit
|
4.7 units on a scale
Standard Deviation 0.4
|
4.8 units on a scale
Standard Deviation 0.3
|
SECONDARY outcome
Timeframe: Up to 72 hours from the intervention and the hopitalary stay and during the next 7 days after dischargeTo assess if the experimental treatment causes less, equal or more adverse events than the comparator treatment.
Outcome measures
| Measure |
Bupivacaine + Morphine Chloride
n=30 Participants
People in this arm will receive treatment with morphine chloride (50 mcgr) in addition to a low dose solution of the local intradural anaesthetic bupivacaine (3mg).
Bupivacaine low dose: A dose of morphine chloride added to a low dose solution of bupivacaine administered intradural.
Morphine Chloride: A dose of morphine chloride added to a low dose solution of bupivacaine administered intradural.
|
Bupivacaine Standard Dose
n=33 Participants
People in this arm will receive treatment with the standard dose of the local intradural anaesthetic bupivacaine (5mg).
Bupivacaine standard dose: Single intradural standard dose of bupivacaine.
|
|---|---|---|
|
Number of Adverse Events
Urinary retention
|
7 participants
|
3 participants
|
|
Number of Adverse Events
Nausea/Vomits
|
0 participants
|
1 participants
|
|
Number of Adverse Events
Fever
|
1 participants
|
0 participants
|
|
Number of Adverse Events
Pruritus
|
2 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Up to 72 hours after the interventionTo see if the hospitalization time is shortened or not by the experimental treatment.
Outcome measures
| Measure |
Bupivacaine + Morphine Chloride
n=30 Participants
People in this arm will receive treatment with morphine chloride (50 mcgr) in addition to a low dose solution of the local intradural anaesthetic bupivacaine (3mg).
Bupivacaine low dose: A dose of morphine chloride added to a low dose solution of bupivacaine administered intradural.
Morphine Chloride: A dose of morphine chloride added to a low dose solution of bupivacaine administered intradural.
|
Bupivacaine Standard Dose
n=33 Participants
People in this arm will receive treatment with the standard dose of the local intradural anaesthetic bupivacaine (5mg).
Bupivacaine standard dose: Single intradural standard dose of bupivacaine.
|
|---|---|---|
|
Time of Hospitalization
1 day of hospitalization
|
26 participants
|
30 participants
|
|
Time of Hospitalization
2 days of hospitalization
|
3 participants
|
2 participants
|
|
Time of Hospitalization
3 days of hospitalization
|
1 participants
|
1 participants
|
Adverse Events
Bupivacaine + Morphine Chloride
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Bupivacaine Standard Dose
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Bupivacaine + Morphine Chloride
n=30 participants at risk
People in this arm will receive treatment with morphine chloride (50 mcgr) in addition to a low dose solution of the local intradural anaesthetic bupivacaine (3mg).
Bupivacaine low dose: A dose of morphine chloride added to a low dose solution of bupivacaine administered intradural.
Morphine Chloride: A dose of morphine chloride added to a low dose solution of bupivacaine administered intradural.
|
Bupivacaine Standard Dose
n=33 participants at risk
People in this arm will receive treatment with the standard dose of the local intradural anaesthetic bupivacaine (5mg).
Bupivacaine standard dose: Single intradural standard dose of bupivacaine.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Pruritus
|
6.7%
2/30 • Number of events 2
|
0.00%
0/33
|
|
Renal and urinary disorders
Urinary retention
|
23.3%
7/30 • Number of events 7
|
9.1%
3/33 • Number of events 3
|
|
Gastrointestinal disorders
Nausea or Vomits
|
0.00%
0/30
|
3.0%
1/33 • Number of events 1
|
|
General disorders
Fever
|
3.3%
1/30 • Number of events 1
|
0.00%
0/33
|
Additional Information
Antonio Rodríguez Miguel
Hospital Universitario Príncipe de Asturias
Phone: +34 91 887 81 00
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place