Pain
Conditions
Keywords
Cesarean Delivery, TAP block, sufentanyl, Narcotic dosages
Brief summary
Adding sufentanyl to bupivacain in Transversus Abdominis Plane (TAP) block under ultrasound guide can reduce narcotic dosage, side effects and pain after cesarean delivery.
Interventions
DRUGSufentanyl
As intervention 1cc sufentanyl is added to bupivacain in case group for TAP block. As comparator 1cc normal saline is added to bupivacain in control group for Tap block.
Sponsors
Tehran University of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
* female 18 to 40 Years * class ASA 1 and 2 * candidates for elective cesarean section
Exclusion criteria
* renal failure * liver failure * cardiac disorder * coagulopathy * hepatomegaly * splenomegaly * drug sensitivity and abuse * morbid obesity * smoking * history of post operative nausea and vomiting * motion sickness * local hypoesthesia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Narcotic Dosage | 24 h |
Secondary
| Measure | Time frame |
|---|---|
| Pain | 24h |
Countries
Iran
Participant flow
Recruitment details
recruitment period: Jan 2012- Dec 2013 Shariati hospital, a tertiary center
Pre-assignment details
Exclusions were based on exclusion criteria previously mentioned.
Participants by arm
| Arm | Count |
|---|---|
| Sufentanyl Group IN case group we add 1cc sufentanyl to 20 cc bupivacain in TAP block | 25 |
| Control Group In control group we add 1cc salin to 20cc bupivacain in TAP block | 25 |
| Total | 50 |
Baseline characteristics
| Characteristic | Control Group | Sufentanyl Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 25 Participants | 25 Participants | 50 Participants |
| Age Continuous | 29.9 years STANDARD_DEVIATION 5.6 | 28.9 years STANDARD_DEVIATION 3.4 | 29.1 years STANDARD_DEVIATION 4.6 |
| Region of Enrollment Iran, Islamic Republic of | 25 participants | 25 participants | 50 participants |
| Sex: Female, Male Female | 25 Participants | 25 Participants | 50 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 25 | 1 / 25 |
| serious Total, serious adverse events | 1 / 25 | 3 / 25 |
Outcome results
Primary
Narcotic Dosage
Time frame: 24 h
Primary
Narcotic Dosage
The total dosage of morphin consumed by the patients in sufentanil or control group.
Time frame: over 24 hours after surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sufentanyl Group | Narcotic Dosage | 37.2 mgm,. | Standard Deviation 16.15 |
| Control Group | Narcotic Dosage | 52.8 mgm,. | Standard Deviation 16.7 |
Secondary
Pain
Time frame: 24h