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Addition of Lidocaine to Levobupivacaine Reduces Intrathecal Block Duration

D

Diskapi Teaching and Research Hospital

Status and phase

Completed
Phase 4

Conditions

Benign Prostate Hyperplasia

Treatments

Drug: levobupivacaine Spinal anesthesia
Drug: Levobupivacaine lidocaine spinal anesthesia

Study type

Interventional

Funder types

Other

Identifiers

NCT01675895
DİLEKLEVOBUPİVACAİNE

Details and patient eligibility

About

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

Full 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).

Enrollment

40 patients

Sex

Male

Ages

40 to 80 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

40 participants in 2 patient groups

Group Levobupivacaine lidocaine
Experimental group
Description:
Group Levobupivacaine lidocaine Spinal anesthesia with 1.5 ml hyperbaric levobupivacaine (6.75 mg) + 0.3 ml 2 % lidocaine
Treatment:
Drug: Levobupivacaine lidocaine spinal anesthesia
Group Control
Active Comparator group
Description:
Group Control levobupivacaine spinal anesthesia with levobupivacaine (6.75 mg) + saline
Treatment:
Drug: levobupivacaine Spinal anesthesia

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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