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Completed

NCT Number: NCT01548794

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

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.

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Key information

Conditions

Anesthesia Hernia Hernia, Abdominal Hernia, Inguinal Inguinal Hernia Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

19 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Diskapi Yildirim Beyazit Training and Research Hospital

Ankara, 06610, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Spinal anesthesia

Procedure

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

Other names: marcaine heavy

infiltration anesthesia

Procedure

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

Other names: marcaine, lidocaine

Primary outcomes

  1. Duration of spinal block

    Time frame: 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 outcomes

  1. Discharge time

    Time frame: Day of surgery

    The time between the end of surgery and home discharge.

Sponsors and collaborators

Lead sponsor

Diskapi Teaching and Research Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Mar 8, 2012
Registry last updated
Apr 22, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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