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Addition of Lidocaine to Levobupivacaine Reduces Intrathecal Block Duration

Addition of Lidocaine to Levobupivacaine Reduces Intrathecal Block Duration: Randomized Controlled Trial

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01675895
Enrollment
40
Registered
2012-08-30
Start date
2009-07-31
Completion date
2011-07-31
Last updated
2012-12-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Benign Prostate Hyperplasia

Keywords

Hyperbaric Levobupivacaine, İntrathecal, Lidocaine, TUR-P

Brief summary

The main objective was to test the hypothesis that adding lidocaine to hyperbaric levobupivacaine could change the duration of levobupivacaine spinal block.

Detailed description

A satisfactory spinal anaesthesia requires both a fast onset and proper duration at the same time. Transurethral resection of the prostate (TUR-P) is a surgery of medium duration. The addition of lidocaine to hyperbaric bupivacaine shortens the duration of bupivacaine spinal block and therefore provides more rapid recovery. This property of lidocaine is not verified with other local anesthetics. Levobupivacaine is a S-enantiomer of racemic bupivacaine and is a long acting local anesthetic.The aim of this prospective randomized controlled study was to investigate this effect of lidocaine, with a local anesthetic other than bupivacaine. It was hypothesized that the duration of the intrathecal block could change when performed with hyperbaric levobupivacaine mixed with low dose lidocaine and this technique could be consistent for the duration of TUR-P surgery. Participants will be followed on the day of surgery for primary and secondary outcome measures and 3 days postoperatively for complications (TNS).

Interventions

DRUGLevobupivacaine lidocaine spinal anesthesia

Spinal anesthesia

DRUGlevobupivacaine Spinal anesthesia

spinal anesthesia

Sponsors

Diskapi Teaching and Research Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
MALE
Age
40 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* elective transurethral resection of the prostate (TUR-P)

Exclusion criteria

* patients with contraindications for spinal anesthesia, * known sensitivity to the study drugs, * emergency cases, and * patients who refused spinal anaesthesia were excluded

Design outcomes

Primary

MeasureTime frameDescription
The duration of the spinal block (S1 regression of the block)participanta will be followed on the operation daythe time between the intrathecal injection and sensorial block regression to S1 dermatome, measured in minutes

Secondary

MeasureTime frameDescription
postoperative care unit stayparticipants will be followed on the operation daythe time between the patient entered the PACU and left the PACU (when the sensorial block was regressed to S1 dermatome and the patient fulfilled an Aldrete score higher or equal to 9), measured in minutes

Other

MeasureTime frameDescription
maximum block levelparticipants will be followed on the operation daythe dermatomal level that the sensorial block reached, determined with the pin prick test, expressed with dermatomes

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026