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

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01548794

Enrollment

Registered

2012-03-08

Start date

2012-03-31

Completion date

2012-06-30

Last updated

2015-04-22

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

Conditions

Anesthesia, Inguinal Hernia

Keywords

spinal anesthesia, bupivacaine, lidocaine, local infiltration anesthesia, recovery, duration of anesthesia, outpatient herniorrhaphy

Brief 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.

Interventions

PROCEDUREspinal anesthesia

To receive 2 ml heavy bupivacaine + 0,6 ml saline

PROCEDUREinfiltration anesthesia

To receive step by step local infiltration anesthesia as described by the Lichtenstein Institute.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

19 Years to 80 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Duration of spinal block	day of surgery	Time between the onset of the sensorial block at L1 dermatome and the resolution of the sensorial block at S3 dermatome.

Secondary

Measure	Time frame	Description
Discharge time	Day of surgery	The time between the end of surgery and home discharge.

Countries

Turkey (Türkiye)

Outcome results

None listed

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