Trial Outcomes & Findings for Ultrasound-Guided Intercostal Nerve Block for Postoperative Pain Relief in Percutaneous Nephrolitotomy (NCT NCT01549405)

Results Overview

Total consumption of tramadol will be measured for the first 24 hours.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

40 participants

Primary outcome timeframe

Postoperative 24th hour

Results posted on

2013-04-02

Participant Flow

Participant milestones

Participant milestones
Measure	Control Group Control group: Group that without intercostal nerve block	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.
Overall Study STARTED	20	20
Overall Study COMPLETED	20	20
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Ultrasound-Guided Intercostal Nerve Block for Postoperative Pain Relief in Percutaneous Nephrolitotomy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Control Group n=20 Participants Control group: Group that without intercostal nerve block	Nerve Block n=20 Participants 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.	Total n=40 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	20 Participants n=5 Participants	20 Participants n=7 Participants	40 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age Continuous	57.3 years STANDARD_DEVIATION 7.4 • n=5 Participants	53 years STANDARD_DEVIATION 13.6 • n=7 Participants	55.1 years STANDARD_DEVIATION 10.2 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	7 Participants n=7 Participants	13 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants	13 Participants n=7 Participants	27 Participants n=5 Participants
Region of Enrollment Turkey	20 participants n=5 Participants	20 participants n=7 Participants	40 participants n=5 Participants

PRIMARY outcome

Timeframe: Postoperative 24th hour

Total consumption of tramadol will be measured for the first 24 hours.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Postoperative 24th hour

Outcome measures

Outcome measures
Measure	Control n=20 Participants Group that without intercostal nerve block	İntercostal Nerve Block n=20 Participants Nerve block group was administered two levels intercostal block (11 and 12th ribs) with 0.5% bupivacaine with epinephrine before surgery.
Total Consumption of Tramadol Will be Measured for the First 24 Hours	199.7 mg Standard Deviation 97.5	77.6 mg Standard Deviation 39.5

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Control n=20 Participants Group that without intercostal nerve block	İntercostal Nerve Block n=20 Participants Nerve block group was administered two levels intercostal block (11 and 12th ribs) with 0.5% bupivacaine with epinephrine before surgery.
Postoperative Pain Will be Evaluated.	3 units on a scale Interval 2.0 to 4.0	1 units on a scale Interval 0.0 to 3.0

Adverse Events

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

İntercostal Nerve Block

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Control n=20 participants at risk Group that without intercostal nerve block	İntercostal Nerve Block n=20 participants at risk Nerve block group was administered two levels intercostal block (11 and 12th ribs) with 0.5% bupivacaine with epinephrine before surgery.
Respiratory, thoracic and mediastinal disorders pneumothorax	0.00% 0/20	0.00% 0/20

Additional Information

Dr Derya Özkan

Ministry of health Diskapi Yıldirim Beyazit Training and Research Hospital

Phone: 00903125962553

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place