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

NCT01845376 | Completed

• 1 other identifier: SIRB035
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hernia; Anesthetics Adverse Reaction; Inflammation

Keywords

Inflammatory Markers after Inguinal Hernia Repair; Anesthetic technique for hernia repair

Outcome Measures

Primary Outcomes (1)

• postoperative pain on mobilization

  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).

  at postoperative 8 hours

Secondary Outcomes (3)

• acute inflammatory markers (IL-1 beta)

  at 8 hours after surgery

• acute inflammatory markers (IL-6)

  at 8 hours after surgery

• acute inflammatory markers (IL-10)

  at 8 hours after surgery

Other Outcomes (3)

• conversion to other anesthetic techniques

  at 2 hours after operation

• postoperative use of analgesics and amount of analgesic medication

  in the period of 24 hours after operation

• incidence of complication

  30 days after operation

Study Arms (3)

local anesthesia group

EXPERIMENTAL

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

spinal anesthesia group

EXPERIMENTAL

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

general anesthesia group

EXPERIMENTAL

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

Interventions

local anesthesia group PROCEDURE

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.

Also known as: LA group

local anesthesia group

spinal anesthesia group PROCEDURE

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.

Also known as: SA group

spinal anesthesia group

general anesthesia group PROCEDURE

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.

Also known as: GA group

general anesthesia group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mingkwan Wongyingsinn, MD: lead

Study Sites (1)

Siriraj hospital

Bangkoknoi, Bangkok, 10700, Thailand

Location

MeSH Terms

Conditions

Hernia; Inflammation

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Study Officials

• Mingkwan Wongyingsinn, MD, MSc

  Department of Anesthesiology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant professor, Doctor

Study Record Dates

• First Submitted: April 26, 2013
• First Posted: May 3, 2013
• Study Start: April 1, 2014
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: July 29, 2016

Record last verified: 2016-07

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)