Comparison of Intratechal Levobupivacaine and Adding With Sufetanil and Fentanyl in Ceserean Section
Study Details
Study Description
Brief Summary
45 pregnant women undergoing cesarean section were enrolled in the study in november 2006 to march 2007. 2 ml of 0.5% levobupivacaine was added to 1 ml of saline in group I, 1 ml of 15 µcg of fentanyl in group II and 1 ml of 1,5 µcg sufentanil in group III by intratechal administration. Hemodynamic parameters, characteristics of sensory and motor blockade, peri-operative and postoperative visual analogue scale (VAS) pain scores, the time to the first analgesic requirement and adverse effects were recorded.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
Phase 2 |
Detailed Description
45 pregnant women undergoing cesarean section were enrolled in the study in november 2006 to march 2007. Using CSE technique, 2 ml of 0.5% levobupivacaine was added to 1 ml of saline in group I, 1 ml of 15 µcg of fentanyl in group II and 1 ml of 1,5 µcg sufentanil in group III by intratechal administration. Hemodynamic parameters, characteristics of sensory and motor blockade, peri-operative and postoperative visual analogue scale (VAS) pain scores, the time to the first analgesic requirement and adverse effects were recorded.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: 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 |
Drug: Levobupivacaine
this used in intratechal area and for spinal anesthesia in ceserean section
Other Names:
|
Experimental: 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 |
Drug: Fentanyl
this used in intratechal area and for spinal anesthesia in ceserean section
Drug: Levobupivacaine
this used in intratechal area and for spinal anesthesia in ceserean section
Other Names:
|
Experimental: 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 |
Drug: Sufentanil
this used in intratechal area and for spinal anesthesia in ceserean section
Other Names:
Drug: Levobupivacaine
this used in intratechal area and for spinal anesthesia in ceserean section
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Number of Participants With Adverse Events as a Measure of Safety and Tolerability [Up to 4 months]
The frequency and the severity (ex) of the side effects including nausea and vomiting, hypotension, pruritus, and bradycardia were recorded.
Secondary Outcome Measures
- Number of Participants With Pain Scores on the Visual Analog Scale [Up to 4 months]
Hemodynamic 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
- pregnant women with a single live fetus aged 18-45 years old and classified as ASA I, undergoing elective cesarean section, were included the study in november 2006 to march 2007
Exclusion Criteria:
-
Multiple pregnancies,
-
preterm labor,
-
eclampsia,
-
preeclampsia,
-
concomitant diabetes mellitus,
-
allergy to local anesthetics, fentanyl or sufentanil,
-
contraindication for regional anesthesia were the exclusion criteria.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Ankara City Hospital Bilkent
Investigators
- Principal Investigator: Müge Çakırca, Ankara Numune Training and Research hospital, Anesthesiology and Reanimation Clinic
Study Documents (Full-Text)
None provided.More Information
Publications
- Burke D, Kennedy S, Bannister J. Spinal anesthesia with 0.5% S(-)-bupivacaine for elective lower limb surgery. Reg Anesth Pain Med. 1999 Nov-Dec;24(6):519-23.
- Lee YY, Muchhal K, Chan CK. Levobupivacaine versus racemic bupivacaine in spinal anaesthesia for urological surgery. Anaesth Intensive Care. 2003 Dec;31(6):637-41.
- Stewart J, Kellett N, Castro D. The central nervous system and cardiovascular effects of levobupivacaine and ropivacaine in healthy volunteers. Anesth Analg. 2003 Aug;97(2):412-416. doi: 10.1213/01.ANE.0000069506.68137.F2.
- 2006-099
Study Results
Participant Flow
Recruitment Details | |
---|---|
Pre-assignment Detail |
Arm/Group Title | Levobupivacaine | Levobupivacaine + Fentanyl | Levobupivacaine + Sufentanil |
---|---|---|---|
Arm/Group Description | 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 | 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 | 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 |
Period Title: Overall Study | |||
STARTED | 15 | 15 | 15 |
COMPLETED | 15 | 15 | 15 |
NOT COMPLETED | 0 | 0 | 0 |
Baseline Characteristics
Arm/Group Title | Levobupivacaine | Levobupivacaine + Fentanyl | Levobupivacaine + Sufentanil | Total |
---|---|---|---|---|
Arm/Group Description | 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 | 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 | 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 of all reporting groups |
Overall Participants | 15 | 15 | 15 | 45 |
Age (years) [Mean (Standard Deviation) ] | ||||
Mean (Standard Deviation) [years] |
27.8
(7.4)
|
25.5
(5.2)
|
27.4
(7.1)
|
26.9
(7.5)
|
Sex: Female, Male (Count of Participants) | ||||
Female |
15
100%
|
15
100%
|
15
100%
|
45
100%
|
Male |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
Race (NIH/OMB) (Count of Participants) | ||||
American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
Asian |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
Black or African American |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
White |
15
100%
|
15
100%
|
15
100%
|
45
100%
|
More than one race |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
Region of Enrollment (participants) [Number] | ||||
Turkey |
15
100%
|
15
100%
|
15
100%
|
45
100%
|
Outcome Measures
Title | Number of Participants With Adverse Events as a Measure of Safety and Tolerability |
---|---|
Description | The frequency and the severity (ex) of the side effects including nausea and vomiting, hypotension, pruritus, and bradycardia were recorded. |
Time Frame | Up to 4 months |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Levobupivacaine | Levobupivacaine + Fentanyl | Levobupivacaine + Sufentanil |
---|---|---|---|
Arm/Group Description | 2 ml of 0.5% levobupivacaine was added to 1 ml of saline in group I by intrathecal administration | 2 ml of 0.5% levobupivacaine was added to 1 ml of 15 µcg of fentanyl in group II by intrathecal administration | 2 ml of 0.5% levobupivacaine was added to 1 ml of 1,5 µcg sufentanil in group III by intrathecal administration |
Measure Participants | 15 | 15 | 15 |
Number [participants] |
5
33.3%
|
10
66.7%
|
9
60%
|
Title | Number of Participants With Pain Scores on the Visual Analog Scale |
---|---|
Description | Hemodynamic 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. |
Time Frame | Up to 4 months |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title |
---|
Arm/Group Description |
Adverse Events
Time Frame | ||||||
---|---|---|---|---|---|---|
Adverse Event Reporting Description | ||||||
Arm/Group Title | Levobupivacaine | Levobupivacaine + Fentanyl | Levobupivacaine + Sufentanil | |||
Arm/Group Description | 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 | 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 | 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 | |||
All Cause Mortality |
||||||
Levobupivacaine | Levobupivacaine + Fentanyl | Levobupivacaine + Sufentanil | ||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | / (NaN) | / (NaN) | / (NaN) | |||
Serious Adverse Events |
||||||
Levobupivacaine | Levobupivacaine + Fentanyl | Levobupivacaine + Sufentanil | ||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/15 (0%) | 0/15 (0%) | 0/15 (0%) | |||
Other (Not Including Serious) Adverse Events |
||||||
Levobupivacaine | Levobupivacaine + Fentanyl | Levobupivacaine + Sufentanil | ||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 5/15 (33.3%) | 10/15 (66.7%) | 12/15 (80%) | |||
Cardiac disorders | ||||||
bradicardia | 0/15 (0%) | 0 | 1/15 (6.7%) | 1 | 2/15 (13.3%) | 2 |
General disorders | ||||||
vomiting | 0/15 (0%) | 0 | 2/15 (13.3%) | 2 | 0/15 (0%) | 0 |
hypotension | 5/15 (33.3%) | 5 | 10/15 (66.7%) | 10 | 9/15 (60%) | 9 |
nausea | 1/15 (6.7%) | 1 | 9/15 (60%) | 9 | 8/15 (53.3%) | 8 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title | Dr. Müge Çakırca |
---|---|
Organization | Ankara Numune Training and Research Hospital |
Phone | +905054433177 |
mugeturkoglu81@hotmail.com |
- 2006-099