Trial Outcomes & Findings for Comparison of Intratechal Levobupivacaine and Adding With Sufetanil and Fentanyl in Ceserean Section (NCT NCT02430090)
NCT ID: NCT02430090
Last Updated: 2021-11-19
Results Overview
The frequency and the severity (ex) of the side effects including nausea and vomiting, hypotension, pruritus, and bradycardia were recorded.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
45 participants
Primary outcome timeframe
Up to 4 months
Results posted on
2021-11-19
Participant Flow
Participant milestones
| Measure |
Levobupivacaine
Levobupivacaine, a local anesthetic agent, is indicated for the production of local or regional anesthesia or analgesia for surgery, for oral surgery procedures, for diagnostic and therapeutic procedures, and for obstetrical procedures.
Injection Surgical anaesthesia
Adult: Epidural block: 50-100 mg (10-20 ml) of a 0.5% solution or 75-150 mg (10-20 ml) of a 0.75% solution. Caesarean section: 75-150 mg (15-30 ml) of a 0.5% solution. Spinal block: 15 mg (3 ml) of a 0.5% solution. Max: 150 mg/dose; 400 mg/day. Injection Peripheral nerve block
Read more: http://www.ndrugs.com/?s=levobupivacaine#ixzz3Xvp0iS5T
Levobupivacaine: this used in intratechal area and for spinal anesthesia in ceserean section
|
Levobupivacaine + Fentanyl
Fentanyl - Used for: Producing anesthesia for surgery and treating pain before, during, and after surgery.Fentanyl is a narcotic (opioid) analgesic. It works in the brain and nervous system to cause anesthesia and decrease pain.
Indications:
Adult: PO Breakthrough cancer pain As a loz: Initially, 200 mcg over 15 minutes for an episode of breakthrough pain; may repeat once after 15 minutes if needed. Not more than 4 unit doses/day. IV Adjunct to general anesth Patients w/ spontaneous resp: Initial: 50-200 mcg, w/ supplements of 50 mcg. Patients w/ assisted ventilation: Initial: 300-3,500 mcg (up to 50 mcg/kg), w/ supplements of 100-200 mcg depending on response.
Read more: http://www.ndrugs.com/?s=fentanyl#ixzz3XvpAcULL
Fentanyl: this used in intratechal area and for spinal anesthesia in ceserean section
Levobupivacaine: this used in intratechal area and for spinal anesthesia in ceserean section
|
Levobupivacaine + Sufentanil
Sufentanil is a synthetic opioid analgesic. Sufentanil exerts its principal pharmacologic effects on the central nervous system. Its primary actions of therapeutic value are analgesia and sedation.
Maintenance: Additional doses of 0.5-10 mcg/kg may be given if needed. Max (total dose): 30 mcg/kg. Post-op pain Initial: 30-60 mcg. Additional doses of up to 25 mcg may be given at intervals of ≥1 hr if needed. Epidural Pain relief during labour and delivery W/ bupivacaine: 10-15 mcg w/ or w/o epinephrine. May repeat dose twice at intervals of ≥1 hr till delivery. Max (total dose): 30 mcg.
Read more: http://www.ndrugs.com/?s=sufentanil#ixzz3XvqVyLzx
Sufentanil: this used in intratechal area and for spinal anesthesia in ceserean section
Levobupivacaine: this used in intratechal area and for spinal anesthesia in ceserean section
|
|---|---|---|---|
|
Overall Study
STARTED
|
15
|
15
|
15
|
|
Overall Study
COMPLETED
|
15
|
15
|
15
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Comparison of Intratechal Levobupivacaine and Adding With Sufetanil and Fentanyl in Ceserean Section
Baseline characteristics by cohort
| Measure |
Levobupivacaine
n=15 Participants
Levobupivacaine, a local anesthetic agent, is indicated for the production of local or regional anesthesia or analgesia for surgery, for oral surgery procedures, for diagnostic and therapeutic procedures, and for obstetrical procedures.
Injection Surgical anaesthesia
Adult: Epidural block: 50-100 mg (10-20 ml) of a 0.5% solution or 75-150 mg (10-20 ml) of a 0.75% solution. Caesarean section: 75-150 mg (15-30 ml) of a 0.5% solution. Spinal block: 15 mg (3 ml) of a 0.5% solution. Max: 150 mg/dose; 400 mg/day. Injection Peripheral nerve block
Read more: http://www.ndrugs.com/?s=levobupivacaine#ixzz3Xvp0iS5T
Levobupivacaine: this used in intratechal area and for spinal anesthesia in ceserean section
|
Levobupivacaine + Fentanyl
n=15 Participants
Fentanyl - Used for: Producing anesthesia for surgery and treating pain before, during, and after surgery.Fentanyl is a narcotic (opioid) analgesic. It works in the brain and nervous system to cause anesthesia and decrease pain.
Indications:
Adult: PO Breakthrough cancer pain As a loz: Initially, 200 mcg over 15 minutes for an episode of breakthrough pain; may repeat once after 15 minutes if needed. Not more than 4 unit doses/day. IV Adjunct to general anesth Patients w/ spontaneous resp: Initial: 50-200 mcg, w/ supplements of 50 mcg. Patients w/ assisted ventilation: Initial: 300-3,500 mcg (up to 50 mcg/kg), w/ supplements of 100-200 mcg depending on response.
Read more: http://www.ndrugs.com/?s=fentanyl#ixzz3XvpAcULL
Fentanyl: this used in intratechal area and for spinal anesthesia in ceserean section
Levobupivacaine: this used in intratechal area and for spinal anesthesia in ceserean section
|
Levobupivacaine + Sufentanil
n=15 Participants
Sufentanil is a synthetic opioid analgesic. Sufentanil exerts its principal pharmacologic effects on the central nervous system. Its primary actions of therapeutic value are analgesia and sedation.
Maintenance: Additional doses of 0.5-10 mcg/kg may be given if needed. Max (total dose): 30 mcg/kg. Post-op pain Initial: 30-60 mcg. Additional doses of up to 25 mcg may be given at intervals of ≥1 hr if needed. Epidural Pain relief during labour and delivery W/ bupivacaine: 10-15 mcg w/ or w/o epinephrine. May repeat dose twice at intervals of ≥1 hr till delivery. Max (total dose): 30 mcg.
Read more: http://www.ndrugs.com/?s=sufentanil#ixzz3XvqVyLzx
Sufentanil: this used in intratechal area and for spinal anesthesia in ceserean section
Levobupivacaine: this used in intratechal area and for spinal anesthesia in ceserean section
|
Total
n=45 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
27.8 years
STANDARD_DEVIATION 7.4 • n=5 Participants
|
25.5 years
STANDARD_DEVIATION 5.2 • n=7 Participants
|
27.4 years
STANDARD_DEVIATION 7.1 • n=5 Participants
|
26.9 years
STANDARD_DEVIATION 7.5 • n=4 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
45 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
45 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
Turkey
|
15 participants
n=5 Participants
|
15 participants
n=7 Participants
|
15 participants
n=5 Participants
|
45 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Up to 4 monthsThe frequency and the severity (ex) of the side effects including nausea and vomiting, hypotension, pruritus, and bradycardia were recorded.
Outcome measures
| Measure |
Levobupivacaine
n=15 Participants
2 ml of 0.5% levobupivacaine was added to 1 ml of saline in group I by intrathecal administration
|
Levobupivacaine + Fentanyl
n=15 Participants
2 ml of 0.5% levobupivacaine was added to 1 ml of 15 µcg of fentanyl in group II by intrathecal administration
|
Levobupivacaine + Sufentanil
n=15 Participants
2 ml of 0.5% levobupivacaine was added to 1 ml of 1,5 µcg sufentanil in group III by intrathecal administration
|
|---|---|---|---|
|
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
|
5 participants
|
10 participants
|
9 participants
|
SECONDARY outcome
Timeframe: Up to 4 monthsHemodynamic parameters, characteristics of sensory and motor blockade, peri-operative and postoperative visual analogue scale (VAS) pain scores, the time to the first analgesic requirement were recorded.
Outcome measures
Outcome data not reported
Adverse Events
Levobupivacaine
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Levobupivacaine + Fentanyl
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Levobupivacaine + Sufentanil
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Levobupivacaine
n=15 participants at risk
Levobupivacaine, a local anesthetic agent, is indicated for the production of local or regional anesthesia or analgesia for surgery, for oral surgery procedures, for diagnostic and therapeutic procedures, and for obstetrical procedures.
Injection Surgical anaesthesia
Adult: Epidural block: 50-100 mg (10-20 ml) of a 0.5% solution or 75-150 mg (10-20 ml) of a 0.75% solution. Caesarean section: 75-150 mg (15-30 ml) of a 0.5% solution. Spinal block: 15 mg (3 ml) of a 0.5% solution. Max: 150 mg/dose; 400 mg/day. Injection Peripheral nerve block
Read more: http://www.ndrugs.com/?s=levobupivacaine#ixzz3Xvp0iS5T
Levobupivacaine: this used in intratechal area and for spinal anesthesia in ceserean section
|
Levobupivacaine + Fentanyl
n=15 participants at risk
Fentanyl - Used for: Producing anesthesia for surgery and treating pain before, during, and after surgery.Fentanyl is a narcotic (opioid) analgesic. It works in the brain and nervous system to cause anesthesia and decrease pain.
Indications:
Adult: PO Breakthrough cancer pain As a loz: Initially, 200 mcg over 15 minutes for an episode of breakthrough pain; may repeat once after 15 minutes if needed. Not more than 4 unit doses/day. IV Adjunct to general anesth Patients w/ spontaneous resp: Initial: 50-200 mcg, w/ supplements of 50 mcg. Patients w/ assisted ventilation: Initial: 300-3,500 mcg (up to 50 mcg/kg), w/ supplements of 100-200 mcg depending on response.
Read more: http://www.ndrugs.com/?s=fentanyl#ixzz3XvpAcULL
Fentanyl: this used in intratechal area and for spinal anesthesia in ceserean section
Levobupivacaine: this used in intratechal area and for spinal anesthesia in ceserean section
|
Levobupivacaine + Sufentanil
n=15 participants at risk
Sufentanil is a synthetic opioid analgesic. Sufentanil exerts its principal pharmacologic effects on the central nervous system. Its primary actions of therapeutic value are analgesia and sedation.
Maintenance: Additional doses of 0.5-10 mcg/kg may be given if needed. Max (total dose): 30 mcg/kg. Post-op pain Initial: 30-60 mcg. Additional doses of up to 25 mcg may be given at intervals of ≥1 hr if needed. Epidural Pain relief during labour and delivery W/ bupivacaine: 10-15 mcg w/ or w/o epinephrine. May repeat dose twice at intervals of ≥1 hr till delivery. Max (total dose): 30 mcg.
Read more: http://www.ndrugs.com/?s=sufentanil#ixzz3XvqVyLzx
Sufentanil: this used in intratechal area and for spinal anesthesia in ceserean section
Levobupivacaine: this used in intratechal area and for spinal anesthesia in ceserean section
|
|---|---|---|---|
|
Cardiac disorders
bradicardia
|
0.00%
0/15
|
6.7%
1/15 • Number of events 1
|
13.3%
2/15 • Number of events 2
|
|
General disorders
vomiting
|
0.00%
0/15
|
13.3%
2/15 • Number of events 2
|
0.00%
0/15
|
|
General disorders
hypotension
|
33.3%
5/15 • Number of events 5
|
66.7%
10/15 • Number of events 10
|
60.0%
9/15 • Number of events 9
|
|
General disorders
nausea
|
6.7%
1/15 • Number of events 1
|
60.0%
9/15 • Number of events 9
|
53.3%
8/15 • Number of events 8
|
Additional Information
Dr. Müge Çakırca
Ankara Numune Training and Research Hospital
Phone: +905054433177
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place