Nerve Block, Intercostal Nerve
Conditions
Keywords
percutanous nephrolitotomy,intercostal nerve block, Ultrasound
Brief summary
Percutaneous nephrolitotomy (PCNL)is an endourological procedure for the management of patients with renal calculi. Postoperative pain around the surgical area and the nephrostomy tube can being a problem. We hypothesized that intercostal nerve block at 11th and 12th rib level would alleviate postoperative pain and reduce analgesic consumption.
Detailed description
Patients admitted for the removal of renal stones by PCNL will included in this study.Primary outcome measure will be analgesic (tramadol )consumption and visual analog scale (VAS).
Interventions
OTHERİntercostal nerve block
Nerve block group was administered two levels intercostal block (11 and 12th ribs) with 0.5% bupivacaine with epinephrine before surgery.
Sponsors
Diskapi Teaching and Research Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Patients admitted for the removal of renal stones by percutaneous * nephrolithotomy (PCNL) * ASA I-II status
Exclusion criteria
* Respiratory or cardiac disfunction * Neuropathy * Coagulopathy * BMI (Body mass index)over 30
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Analgesic (Tramadol) Consumption | Postoperative 24th hour | Total consumption of tramadol will be measured for the first 24 hours. |
| Total Consumption of Tramadol Will be Measured for the First 24 Hours | Postoperative 24th hour | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Pain Will be Evaluated. | 24 hours | The pain score (VAS)(visual analog scale) will be evaluated for the first 24 hours.(0 no pain, to 10, the maximum pain )Pain score less then 4 is acceptable. |
Countries
Turkey (Türkiye)
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Control Group Control group: Group that without intercostal nerve block | 20 |
| Nerve Block Group that performing intercostal block
İntercostal nerve block : Nerve block group was administered two levels intercostal block (11 and 12th ribs) with 0.5% bupivacaine with epinephrine before surgery. | 20 |
| Total | 40 |
Baseline characteristics
| Characteristic | Nerve Block | Control 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 | 20 Participants | 20 Participants | 40 Participants |
| Age Continuous | 53 years STANDARD_DEVIATION 13.6 | 57.3 years STANDARD_DEVIATION 7.4 | 55.1 years STANDARD_DEVIATION 10.2 |
| Region of Enrollment Turkey | 20 participants | 20 participants | 40 participants |
| Sex: Female, Male Female | 7 Participants | 6 Participants | 13 Participants |
| Sex: Female, Male Male | 13 Participants | 14 Participants | 27 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 20 | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 |
Outcome results
Primary
Postoperative Analgesic (Tramadol) Consumption
Total consumption of tramadol will be measured for the first 24 hours.
Time frame: Postoperative 24th hour
Primary
Total Consumption of Tramadol Will be Measured for the First 24 Hours
Time frame: Postoperative 24th hour
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Total Consumption of Tramadol Will be Measured for the First 24 Hours | 199.7 mg | Standard Deviation 97.5 |
| İntercostal Nerve Block | Total Consumption of Tramadol Will be Measured for the First 24 Hours | 77.6 mg | Standard Deviation 39.5 |
p-value: 095% CI: [52.98, 132.4]t-test, 2 sided
Secondary
Postoperative Pain Will be Evaluated.
The pain score (VAS)(visual analog scale) will be evaluated for the first 24 hours.(0 no pain, to 10, the maximum pain )Pain score less then 4 is acceptable.
Time frame: 24 hours
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Control | Postoperative Pain Will be Evaluated. | 3 units on a scale |
| İntercostal Nerve Block | Postoperative Pain Will be Evaluated. | 1 units on a scale |
p-value: 0.002Mann-Whitney U test