Recovery of Bupivacaine or Bupivacaine-Lidocaine Spinal Anesthesia and Infiltration Anesthesia in Herniorrhaphy
Information source: Diskapi Teaching and Research Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Anesthesia; Inguinal Hernia
Intervention: spinal anesthesia (Procedure); spinal anesthesia (Procedure); infiltration anesthesia (Procedure)
Phase: Phase 4
Status: Completed
Sponsored by: Diskapi Teaching and Research Hospital Official(s) and/or principal investigator(s):
Dilek Yazicioglu, Principal Investigator
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.
Clinical Details
Official title: A Comparison of the Recovery Profiles of Bupivacaine or Bupivacaine Mixed With Lidocaine Spinal Anesthesia and Local Infiltration Anesthesia for Outpatient Herniorrhaphy
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)
Primary outcome: Duration of spinal block
Secondary outcome: Discharge time
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.
Eligibility
Minimum age: 19 Years.
Maximum age: 80 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Diskapi Yildirim Beyazit Training and Research Hospital, Ankara 06610, Turkey
Additional Information
Related publications: 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.
Starting date: March 2012
Last updated: April 21, 2015
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