Local or Regional or General Anesthesia for Hernia Repair: a Randomized Controlled Trial

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified April 2013 by Siriraj Hospital
Sponsor:
Information provided by (Responsible Party):
Mingkwan Wongyingsinn, MD, Siriraj Hospital
ClinicalTrials.gov Identifier:
NCT01845376
First received: April 26, 2013
Last updated: April 29, 2013
Last verified: April 2013
  Purpose

This present randomized trial is designed to evaluate the postoperative pain,inflammatory marker, postoperative analgesic medication, length of hospital stay and the modifications of inflammatory mediators in patients undergoing inguinal hernia repair using local, spinal or general anesthesia.


Condition Intervention
Hernia
Anesthetics Adverse Reaction
Inflammation
Procedure: local anesthesia group
Procedure: spinal anesthesia group
Procedure: general anesthesia group

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Postoperative Clinical Outcomes and Inflammatory Markers After Inguinal Hernia Repair With Local or Spinal or General Anesthesia: A Randomized Trial

Resource links provided by NLM:


Further study details as provided by Siriraj Hospital:

Primary Outcome Measures:
  • postoperative pain on mobilization [ Time Frame: at postoperative 8 hours ] [ Designated as safety issue: No ]
    postoperative pain on mobilization at postoperative 8 hour. postoperative pain is measured with verbal rating score (VRS) from 0 (no pain) to 10 (worst pain).


Secondary Outcome Measures:
  • acute inflammatory markers (IL-1 beta) [ Time Frame: at 8 hours after surgery ] [ Designated as safety issue: No ]
    All samples will be measured in duplicate, with averages used in the statistical analyses. The minimum detectable concentrations IL-1 beta, IL-6 and IL-10 are 0.5 pg /ml, 1.6 pg /ml and 2 pg /ml, respectively.

  • acute inflammatory markers (IL-6) [ Time Frame: at 8 hours after surgery ] [ Designated as safety issue: No ]
    All samples will be measured in duplicate, with averages used in the statistical analyses.

  • acute inflammatory markers (IL-10) [ Time Frame: at 8 hours after surgery ] [ Designated as safety issue: No ]
    All samples will be measured in duplicate, with averages used in the statistical analyses.


Other Outcome Measures:
  • conversion to other anesthetic techniques [ Time Frame: at 2 hours after operation ] [ Designated as safety issue: No ]
  • postoperative use of analgesics and amount of analgesic medication [ Time Frame: in the period of 24 hours after operation ] [ Designated as safety issue: Yes ]
  • incidence of complication [ Time Frame: 30 days after operation ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 54
Study Start Date: April 2013
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: local anesthesia group
In the local anesthesia group, patients will receive local anesthesia similar to that described by Amid et al. except that 1% lidocaine with adrenaline (1:200,000) will be used instead of a mixture of lidocaine and bupivacaine. Surgeons will be taught to do the local anesthetic technique in a standardized manner.
Procedure: local anesthesia group
Patients will receive local anesthesia similar to that described by Amid et al. except that 1% lidocaine with adrenaline (1:200,000) will be used instead of a mixture of lidocaine and bupivacaine.
Other Name: LA group
Experimental: spinal anesthesia group
In the spinal anesthesia group, patients will be positioned in the lateral position and a Whitacre 25 G needle will be inserted at L3-4 intervertebral space and then heavy bupivacaine 0.5% 15 mg will be injected. Sensory block (T4 and below dermatomes) to cold and pinprick will be tested before starting operation. An incremental dose containing 1 mg of midazolam and 25 mcg of fentanyl will be intravenously given if patients in the LA and SA group require.
Procedure: spinal anesthesia group
Patients will be positioned in the lateral position and a Whitacre 25 G needle will be inserted at L3-4 intervertebral space and then heavy bupivacaine 0.5% 15 mg will be injected.
Other Name: SA group
Experimental: general anesthesia group
In the general anesthesia group, patients will be induced with propofol 2 mg/kg and fentanyl 1.5 µg /kg. They are then allowed to breathe spontaneously with sevoflurane 2% to 2.5% in a mixture of 60% oxygen through a laryngeal mask. End-tidal concentration of sevoflurane will be adjusted to keep end-tidal sevoflurane 1MAC. Supplemental doses of 25 µg of fentanyl will be administered if intraoperative heart rate and blood pressure are greater than 20% of baseline.
Procedure: general anesthesia group
Patients will be induced with propofol 2 mg/kg and fentanyl 1.5 µg /kg. They are then allowed to breathe spontaneously with sevoflurane 2% to 2.5% in a mixture of 60% oxygen through a laryngeal mask. End-tidal concentration of sevoflurane will be adjusted to keep end-tidal sevoflurane 1MAC. Supplemental doses of 25 µg of fentanyl will be administered if intraoperative heart rate and blood pressure are greater than 20% of baseline.
Other Name: GA group

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients scheduled to undergo elective unilateral inguinal hernia repair at Siriraj Hospital will be undertaken.
  • ASA I-III,
  • Age greater than 18 years old

Exclusion Criteria:

  • Allergy to any medication used this study,
  • Femoral hernia, recurrent hernia, bilateral hernia,
  • Bleeding abnormalities,
  • Severe hepatic, renal or cardiovascular disease,
  • Chronic use of opioid,
  • History of using steroidal or nonsteroidal anti-inflammatory drugs in the past 6 months,
  • Inability to communicate in Thai or to understand the purpose of the study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01845376

Contacts
Contact: Mingkwan Wongyingsinn, MD, MSc (02)-419-7995 minkcheerful@hotmail.com
Contact: Sirada Phojai, MD (02)-419-7995

Locations
Thailand
Siriraj hospital
Bangkoknoi, Bangkok, Thailand, 10700
Sponsors and Collaborators
Mingkwan Wongyingsinn, MD
Investigators
Principal Investigator: Mingkwan Wongyingsinn, MD, MSc Department of Anesthesiology
  More Information

No publications provided

Responsible Party: Mingkwan Wongyingsinn, MD, Assistant professor, Doctor, Siriraj Hospital
ClinicalTrials.gov Identifier: NCT01845376     History of Changes
Other Study ID Numbers: SIRB035
Study First Received: April 26, 2013
Last Updated: April 29, 2013
Health Authority: Thailand: Ethical Committee

Keywords provided by Siriraj Hospital:
Inflammatory Markers after Inguinal Hernia Repair
Anesthetic technique for hernia repair

Additional relevant MeSH terms:
Hernia
Hernia, Inguinal
Hernia, Abdominal
Inflammation
Pathological Conditions, Anatomical
Pathologic Processes
Anesthetics
Sevoflurane
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Platelet Aggregation Inhibitors
Hematologic Agents
Anesthetics, Inhalation
Anesthetics, General

ClinicalTrials.gov processed this record on August 20, 2014