Clinical Trials Directory

Trials / Completed

CompletedNCT01548794

Recovery of Bupivacaine or Bupivacaine-Lidocaine Spinal Anesthesia and Infiltration Anesthesia in Herniorrhaphy

A Comparison of the Recovery Profiles of Bupivacaine or Bupivacaine Mixed With Lidocaine Spinal Anesthesia and Local Infiltration Anesthesia for Outpatient Herniorrhaphy

Status
Completed
Phase
Phase 4
Study type
Interventional
Enrollment
93 (actual)
Sponsor
Diskapi Teaching and Research Hospital · Academic / Other
Sex
All
Age
19 Years – 80 Years
Healthy volunteers
Not accepted

Summary

The purpose of this study is the investigation of whether adding lidocaine to hyperbaric bupivacaine could decrease the duration of bupivacaine spinal block and provide shorter recovery and discharge times than local infiltration anesthesia in outpatient herniorrhaphy procedures.

Detailed description

Consecutive 93 patients undergoing inguinal herniorrhaphy will be recruited with a prospective protocol.Spinal anesthesia will be commenced in Group BLS with 2 ml hyperbaric bupivacaine (10 mg) + 0.6 ml 1 % lidocaine (6 mg), in Group BS, hyperbaric bupivacaine (10 mg) + saline in the same volume and Group LIA will have anesthesia with bupivacaine and lidocaine for step by step local anesthetic infiltration. Sensorial block will be measured with pinprick test, motor block will be tested with Bromage scale. Heart rate, blood pressure and peripheral oxygen saturation will be measured every 5 minutes. Time of subarachnoid injection, onset of sensorial block (block at L1 dermatome), time to block T10 dermatome, maximum block level, time to maximum block and time to two segment regression, T10 regression , LI regression and S1 regression of the block will be recorded in group BLS and BS.The onset and resolution of the sensorial and motor block will be assessed by anesthetists blinded to group allocation. PACU stay and discharge times and VAS pain scores will be recorded in all patients. Patients also will be investigated for adverse events (hypotension, bradycardia, nausea,PDPH, TNS, urinary retention)and satisfaction regarding the anesthetic method.

Conditions

Interventions

TypeNameDescription
PROCEDUREspinal anesthesiaTo receive 2 ml heavy bupivacaine + 0,6 ml saline
PROCEDUREspinal anesthesiaTo receive 2ml bupivacaine +0,6 ml 1% lidocaine for spinal anesthesia.
PROCEDUREinfiltration anesthesiaTo receive step by step local infiltration anesthesia as described by the Lichtenstein Institute.

Timeline

Start date
2012-03-01
Primary completion
2012-06-01
Completion
2012-06-01
First posted
2012-03-08
Last updated
2015-04-22

Locations

1 site across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT01548794. Inclusion in this directory is not an endorsement.