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

Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01548794
• Other study ID #: DiskapiTRHDYAZICIOGLU
• Status: Completed
• Phase: Phase 4
• First received: March 6, 2012
• Last updated: April 21, 2015
• Start date: March 2012
• Est. completion date: June 2012

Study information

• Verified date: December 2012
• Source: Diskapi Teaching and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 93
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

• Anesthesia
• Hernia, Inguinal
• Inguinal Hernia

Intervention

Procedure:
• spinal anesthesia
To receive 2 ml heavy bupivacaine + 0,6 ml saline
• spinal anesthesia
To receive 2ml bupivacaine +0,6 ml 1% lidocaine for spinal anesthesia.
• infiltration anesthesia
To receive step by step local infiltration anesthesia as described by the Lichtenstein Institute.

Locations

Country	Name	City	State
Turkey	Diskapi Yildirim Beyazit Training and Research Hospital	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Diskapi Teaching and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

Lee SJ, Bai SJ, Lee JS, Kim WO, Shin YS, Lee KY. The duration of intrathecal bupivacaine mixed with lidocaine. Anesth Analg. 2008 Sep;107(3):824-7. doi: 10.1213/ane.0b013e3181806149. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of spinal block	Time between the onset of the sensorial block at L1 dermatome and the resolution of the sensorial block at S3 dermatome.	day of surgery	No
Secondary	Discharge time	The time between the end of surgery and home discharge.	Day of surgery	No