Trial Outcomes & Findings for Lidocaine Combined Dexmedetomidine for Obturator Nerve Block (NCT NCT02066727)

Results Overview

Median effective concentration(EC50) was not calculated per-participants, the "up-and-down" sequential allocation method was used to determine the median effective concentration(EC50) of lidocaine, running the two groups in parallel. The concentration of lidocaine for the second and subsequent patients in each group were dictated by the response of the previous patient in the group, such that an effective block led to a decreased concentration of the next patient, an ineffective block led to an increased concentration. For each group, we collected: the logarithm of lidocaine concentration, the number of effective block, ineffective block, total number of the patient, and successful rate. Then lgEC50 and slgEC50 was calculated as formulas. The logarithm of confidence intervals(95% CI) was calculated as lgEC50±1.96slgEC50. All of the calculation can be performed by SPSS19.0 for windows.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

60 participants

Primary outcome timeframe

10min

Results posted on

2014-12-22

Participant Flow

The patients with the following condition was excluded from the study: ASA III orIV; weight \<50 or \>100 kg；BMI\<19 or \>30kg/m2；age younger than 18 yr or older than 80yr；preexisting neurologic deficits of the lower extremities, DM; alcohol or drug abuse; abnormal coagulation function

Participant milestones

Participant milestones
Measure	Normal Saline Normal Saline is administrated as an adjuvant of lidocaine.	Dexmedetomidine Dexmedetomidine is administrated as an adjuvant of lidocaine at a dose of 1.0 μg/ kg.
Overall Study STARTED	30	30
Overall Study COMPLETED	30	30
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Lidocaine Combined Dexmedetomidine for Obturator Nerve Block

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Normal Saline n=30 Participants Normal Saline is administrated as an adjuvant of lidocaine.	Dexmedetomidine n=30 Participants Dexmedetomidine is administrated as an adjuvant of lidocaine at a dose of 1.0 μg/ kg.	Total n=60 Participants Total of all reporting groups
Age, Continuous	62 years STANDARD_DEVIATION 14 • n=5 Participants	68 years STANDARD_DEVIATION 9 • n=7 Participants	65 years STANDARD_DEVIATION 12 • n=5 Participants
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	18 Participants n=5 Participants	21 Participants n=7 Participants	39 Participants n=5 Participants
Age, Categorical >=65 years	12 Participants n=5 Participants	9 Participants n=7 Participants	21 Participants 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	24 Participants n=5 Participants	23 Participants n=7 Participants	47 Participants n=5 Participants
Region of Enrollment China	30 participants n=5 Participants	30 participants n=7 Participants	60 participants n=5 Participants

PRIMARY outcome

Timeframe: 10min

Median effective concentration(EC50) was not calculated per-participants, the "up-and-down" sequential allocation method was used to determine the median effective concentration(EC50) of lidocaine, running the two groups in parallel. The concentration of lidocaine for the second and subsequent patients in each group were dictated by the response of the previous patient in the group, such that an effective block led to a decreased concentration of the next patient, an ineffective block led to an increased concentration. For each group, we collected: the logarithm of lidocaine concentration, the number of effective block, ineffective block, total number of the patient, and successful rate. Then lgEC50 and slgEC50 was calculated as formulas. The logarithm of confidence intervals(95% CI) was calculated as lgEC50±1.96slgEC50. All of the calculation can be performed by SPSS19.0 for windows.

Outcome measures

Outcome measures
Measure	Normal Saline n=30 Participants Normal Saline is administrated as an adjuvant of lidocaine. Normal Saline: Normal Saline is administrated as an adjuvant of lidocaine.	Dexmedetomidine n=30 Participants Dexmedetomidine is administrated as an adjuvant of lidocaine at a dose of 1.0 μg/ kg. Dexmedetomidine: Dexmedetomidine is administrated as an adjuvant of lidocaine at a dose of 1.0 μg/ kg.
Median Effective Concentration(EC50)	5.7 mg/ml(the concentration of lidocaine) Interval 5.4 to 6.2	2.9 mg/ml(the concentration of lidocaine) Interval 2.8 to 3.8

SECONDARY outcome

Timeframe: during operation, 0.5,24hour postoperatively

Complication related with nerve block is defined as the presence of either bradycardia, delayed recovery, persistent groin pain, neuropathy during operation and postoperatively

Outcome measures

Outcome data not reported

Adverse Events

Normal Saline

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Dexmedetomidine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Yuechun LU

Tianjin Medical University General Hospital

Phone: 15902233666

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place