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

Phase 4

Completed

• Conditions: Inguinal Hernia; Anesthesia
• Interventions: Procedure: infiltration anesthesia; Procedure: spinal anesthesia

• Registration Number: NCT01548794
• Lead Sponsor: Diskapi Teaching and Research Hospital

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.

Study Timeline

• Study Start: 2012-03
• Study First Submitted: 2012-03-06
• Study First Submitted QC: 2012-03-07
• Study First Posted: 2012-03-08
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Status Verified: 2012-12
• Last Update Submitted: 2015-04-21
• Last Update Posted: 2015-04-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 93

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Local Infitration Anesthesia(Group LI)	infiltration anesthesia	local infiltration anesthesia
Bupivacaine+Lidocaine (Group BL)	spinal anesthesia	spinal anesthesia
Bupivacaine(Group B)	spinal anesthesia	spinal anesthesia

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Discharge time	Day of surgery	The time between the end of surgery and home discharge.

Trial Locations

Locations (1)

Diskapi Yildirim Beyazit Training and Research Hospital; 🇹🇷 Ankara, Turkey