Addition of Lidocaine to Levobupivacaine Reduces Intrathecal Block Duration

Phase 4

Completed

• Conditions: Benign Prostate Hyperplasia
• Interventions: Drug: Levobupivacaine lidocaine spinal anesthesia; Drug: levobupivacaine Spinal anesthesia

• Registration Number: NCT01675895
• Lead Sponsor: Diskapi Teaching and Research Hospital

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).

Study Timeline

• Study Start: 2009-07
• Primary Completion: 2011-07
• Study Completion: 2011-07
• Study First Submitted: 2012-08-24
• Study First Submitted QC: 2012-08-29
• Study First Posted: 2012-08-30
• Status Verified: 2012-12
• Last Update Submitted: 2012-12-17
• Last Update Posted: 2012-12-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group Levobupivacaine lidocaine	Levobupivacaine lidocaine spinal anesthesia	Group Levobupivacaine lidocaine Spinal anesthesia with 1.5 ml hyperbaric levobupivacaine (6.75 mg) + 0.3 ml 2 % lidocaine
Group Control	levobupivacaine Spinal anesthesia	Group Control levobupivacaine spinal anesthesia with levobupivacaine (6.75 mg) + saline

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
postoperative care unit stay	participants will be followed on the operation day	the 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

Trial Locations

Locations (1)

Ankara Diskapi Yildirim Beyazit Teaching and Research Hospital; 🇹🇷 Ankara, Turkey