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

D

Diskapi Teaching and Research Hospital

Status and phase

Completed
Phase 4

Conditions

Inguinal Hernia
Anesthesia

Treatments

Procedure: infiltration anesthesia
Procedure: spinal anesthesia

Study type

Interventional

Funder types

Other

Identifiers

NCT01548794
DiskapiTRHDYAZICIOGLU

Details and patient eligibility

About

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.

Full 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.

Enrollment

93 patients

Sex

All

Ages

19 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients having inguinal hernia
  • Not hypersensitive to study drugs
  • ASA classification I-III

Exclusion criteria

  • ASA classification IV-V
  • Contraindications for spinal anesthesia

Trial design

93 participants in 3 patient groups

Bupivacaine(Group B)
Active Comparator group
Description:
spinal anesthesia
Treatment:
Procedure: spinal anesthesia
Procedure: spinal anesthesia
Bupivacaine+Lidocaine (Group BL)
Experimental group
Description:
spinal anesthesia
Treatment:
Procedure: spinal anesthesia
Procedure: spinal anesthesia
Local Infitration Anesthesia(Group LI)
Active Comparator group
Description:
local infiltration anesthesia
Treatment:
Procedure: infiltration anesthesia

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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