Trial Outcomes & Findings for Spinal Anaesthesia With Levobupivacaine 0.5% and Ropivacaine 0.75% for Lower Limb Orthopaedic Surgery (NCT NCT02201784)

Results Overview

Defined as time for first analgesic request by the patient

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

60 participants

Primary outcome timeframe

8 hours

Results posted on

2015-01-21

Participant Flow

jawaharlal nehru medical college and hospital

Patients who met any of the exclusion criteria or those who did not gave consent were excluded.

Participant milestones

Participant milestones
Measure	Levobupivacaine 0.5% intrathecal administration of 15 mg of Levobupivacaine 0.5% Levobupivacaine: Comparison of Equipotent doses	Ropivacaine 0.75% intrathecal administration of 22.5 mg of Ropivacaine 0.75% Ropivacaine: Comparison of equipotent doses
Overall Study STARTED	30	30
Overall Study COMPLETED	28	30
Overall Study NOT COMPLETED	2	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Levobupivacaine 0.5% intrathecal administration of 15 mg of Levobupivacaine 0.5% Levobupivacaine: Comparison of Equipotent doses	Ropivacaine 0.75% intrathecal administration of 22.5 mg of Ropivacaine 0.75% Ropivacaine: Comparison of equipotent doses
Overall Study Failure to achieve adequate block	2	0

Baseline Characteristics

Spinal Anaesthesia With Levobupivacaine 0.5% and Ropivacaine 0.75% for Lower Limb Orthopaedic Surgery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Levobupivacaine 0.5% n=30 Participants intrathecal administration of 15 mg of Levobupivacaine 0.5% Levobupivacaine: Comparison of Equipotent doses	Ropivacaine 0.75% n=30 Participants intrathecal administration of 22.5 mg of Ropivacaine 0.75% Ropivacaine: Comparison of equipotent doses	Total n=60 Participants Total of all reporting groups
Age, Continuous	38 years STANDARD_DEVIATION 17 • n=5 Participants	35 years STANDARD_DEVIATION 16 • n=7 Participants	37 years STANDARD_DEVIATION 16 • 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 India	30 participants n=5 Participants	30 participants n=7 Participants	60 participants n=5 Participants
Weight	53.83 kg STANDARD_DEVIATION 9.44 • n=5 Participants	57.17 kg STANDARD_DEVIATION 6.65 • n=7 Participants	55.5 kg STANDARD_DEVIATION 8.27 • n=5 Participants

PRIMARY outcome

Timeframe: 8 hours

Defined as time for first analgesic request by the patient

Outcome measures

Outcome measures
Measure	Levobupivacaine 0.5% n=28 Participants intrathecal administration of 15 mg of Levobupivacaine 0.5% Levobupivacaine: Comparison of Equipotent doses	Ropivacaine 0.75% n=30 Participants intrathecal administration of 22.5 mg of Ropivacaine 0.75% Ropivacaine: Comparison of equipotent doses
Duration of Analgesia	309.83 minutes Standard Deviation 36.45	249.50 minutes Standard Deviation 22.83

SECONDARY outcome

Timeframe: 30 minutes

level of sensory block was assessed every 5 minutes till the loss of sensation to pinprick, using 22-guage hypodermic needle with 2mm protrusion through guard. Assessments continued at 30 min intervals following the completion of surgery until normal sensation returned.

Outcome measures

Outcome measures
Measure	Levobupivacaine 0.5% n=28 Participants intrathecal administration of 15 mg of Levobupivacaine 0.5% Levobupivacaine: Comparison of Equipotent doses	Ropivacaine 0.75% n=30 Participants intrathecal administration of 22.5 mg of Ropivacaine 0.75% Ropivacaine: Comparison of equipotent doses
Onset of Sensory Block at T10	13.50 minutes Standard Deviation 4.94	7.33 minutes Standard Deviation 2.54

SECONDARY outcome

Timeframe: 8 hours

level of sensory block was assessed every 5 minutes till the loss of sensation to pinprick, using 22-guage hypodermic needle with 2mm protrusion through guard. Assessments continued at 30 min intervals following the completion of surgery until normal sensation returned.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 8 hours

Outcome measures

Outcome measures
Measure	Levobupivacaine 0.5% n=28 Participants intrathecal administration of 15 mg of Levobupivacaine 0.5% Levobupivacaine: Comparison of Equipotent doses	Ropivacaine 0.75% n=30 Participants intrathecal administration of 22.5 mg of Ropivacaine 0.75% Ropivacaine: Comparison of equipotent doses
Time to Maximum Cephalic Spread of Sensory Block	20.33 minutes Standard Deviation 5.31	13.17 minutes Standard Deviation 3.02

SECONDARY outcome

Timeframe: 8 hours

Motor block in the lower limbs was graded according to the modified Bromage scale (Grade 0 = No motor block, Grade 1 = Inability to raise extended leg, able to move knees and feet, Grade 2 = Inability to raise extended leg and move knee, able to move feet, Grade 3 = Complete motor block of the lower limbs). Thereafter, It was performed every 5 minutes till the attainment of MB grade 3 followed by every 30 minutes until complete recovery (MB grade0).

Outcome measures

Outcome measures
Measure	Levobupivacaine 0.5% n=28 Participants intrathecal administration of 15 mg of Levobupivacaine 0.5% Levobupivacaine: Comparison of Equipotent doses	Ropivacaine 0.75% n=30 Participants intrathecal administration of 22.5 mg of Ropivacaine 0.75% Ropivacaine: Comparison of equipotent doses
Onset of Motor Block to Bromage3	12.17 minutes Standard Deviation 4.09	7.83 minutes Standard Deviation 2.84

SECONDARY outcome

Timeframe: 8 hours

Time when the Bromage score will be back to zero

Outcome measures

Outcome measures
Measure	Levobupivacaine 0.5% n=28 Participants intrathecal administration of 15 mg of Levobupivacaine 0.5% Levobupivacaine: Comparison of Equipotent doses	Ropivacaine 0.75% n=30 Participants intrathecal administration of 22.5 mg of Ropivacaine 0.75% Ropivacaine: Comparison of equipotent doses
Duration of Motor Block	290.50 minutes Standard Deviation 34.67	222.50 minutes Standard Deviation 23.00

OTHER_PRE_SPECIFIED outcome

Timeframe: 8 hours

Intragroup and intergroup variation compared

Outcome measures

Outcome data not reported

Adverse Events

Levobupivacaine 0.5%

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

Ropivacaine 0.75%

Serious events: 0 serious events

Other events: 13 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Levobupivacaine 0.5% n=30 participants at risk intrathecal administration of 15 mg of Levobupivacaine 0.5% Levobupivacaine: Comparison of Equipotent doses	Ropivacaine 0.75% n=30 participants at risk intrathecal administration of 22.5 mg of Ropivacaine 0.75% Ropivacaine: Comparison of equipotent doses
Gastrointestinal disorders Nausea	13.3% 4/30	6.7% 2/30
Cardiac disorders Bradycardia	6.7% 2/30	6.7% 2/30
General disorders Shivering	10.0% 3/30	16.7% 5/30
Cardiac disorders Hypotension	23.3% 7/30	33.3% 10/30

Additional Information

Dr. Manazir Athar

Jawaharlal Nehru Medical College, AMU, Aligarh, India

Phone: +918868056469

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place