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Transversus Abdominis Plane Block Versus Ilioinguinal Nerve Block for Pain Management in Inguinal Herniorraphy

Sponsor
Bozyaka Training and Research Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT02375100
Collaborator
(none)
90
Enrollment
1
Location
3
Arms
8
Duration (Months)
11.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study compares efficacy of transversus abdominis plane block and ilioinguinal nerve block for postoperative pain in patients undergoing inguinal herniorraphy with spinal anesthesia. One-third of the patients will receive standard postoperative pain regimen(control group), one-third will receive a transversus abdominis plane block (with ultrasound guidance) and the last group will receive an ilioinguinal nerve block(with ultrasound guidance) in addition to standard postoperative pain regimen. This study is a Randomized prospective open-label controlled study.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Spinal Anesthesia
  • Procedure: Transversus Abdominis Plane Block
  • Procedure: Ilioinguinal Nerve Block
  • Drug: Bupivacaine %0.5 (hyperbaric)
  • Drug: Bupivacaine %0.25 (isobaric)
  • Device: 25G Quincke needle
  • Device: Echogenic Needle with 30° bevel
  • Drug: Acetaminophen
  • Drug: Tramadol
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
90 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Comparison of Efficacy of Transversus Abdominis Plane Block and Ilioinguinal Nerve Block for Postoperative Pain Management in Patients Undergoing Inguinal Herniorraphy With Spinal Anesthesia
Study Start Date :
Feb 1, 2015
Actual Primary Completion Date :
Oct 1, 2015
Actual Study Completion Date :
Oct 1, 2015

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Intrathecal bupivacaine&analgesics

Patients will be given standard care during perioperative period. They will undergo inguinal herniorraphy operation under spinal anesthesia (with 3ml of %0.5 hyperbaric bupivacaine intrathecally) and receive an parenteral pain regimen (acetaminophen for intravenous infusion in two doses routinely and intramuscular tramadol 50 mg when pain score is higher than 4) in postoperative period.

Procedure: Spinal Anesthesia
All patients will be administered 3ml of %0.5 bupivacaine through L3-L4 interspace to acquire motor and sensory blockade
Other Names:
  • Spinal Block

    • Drug: Bupivacaine %0.5 (hyperbaric)
    Other Names:
  • Heavy bupivacaine

    • Device: 25G Quincke needle

    Drug: Acetaminophen
    Analgesic drug administration through iv and im route postoperatively. Patients are administered iv acetaminophen 1g twice a day routinely
    Other Names:
  • Analgesics

    • Drug: Tramadol
    Patients will be administered tramadol in postoperative period when their pain score exceeds 4 points (moderate pain)
    Other Names:
  • Analgesics

    		•
    Experimental: TAP Block with bupivacaine

    In addition to standard perioperative care (spinal anesthesia and parenteral pain regimen) patients will receive transversus abdominis plane block (with 20ml of %0.25 isobaric bupivacaine) just before surgery is initiated.

    Procedure: Spinal Anesthesia
    All patients will be administered 3ml of %0.5 bupivacaine through L3-L4 interspace to acquire motor and sensory blockade
    Other Names:
  • Spinal Block

    • Procedure: Transversus Abdominis Plane Block
    Analgesic intervention which will be performed only to Transversus Abdominis Plane Block arm. It requires 20ml of %0.25 bupivacaine administration through a 22 G. x 4 in. (100 mm) Insulated Echogenic Needle with 30° Bevel from midaxillary line between costal margin and anterior superior iliac spine with ultrasound guidance
    Other Names:
  • TAP block

    • Drug: Bupivacaine %0.5 (hyperbaric)
    Other Names:
  • Heavy bupivacaine

    • Drug: Bupivacaine %0.25 (isobaric)
    Other Names:
  • Plain bupivacaine

    • Device: 25G Quincke needle

    Device: Echogenic Needle with 30° bevel

    Drug: Acetaminophen
    Analgesic drug administration through iv and im route postoperatively. Patients are administered iv acetaminophen 1g twice a day routinely
    Other Names:
  • Analgesics

    • Drug: Tramadol
    Patients will be administered tramadol in postoperative period when their pain score exceeds 4 points (moderate pain)
    Other Names:
  • Analgesics

    		•
    Experimental: IlNB with bupivacaine

    In addition to standard perioperative care (spinal anesthesia and parenteral pain regimen) patients will receive Ilioinguinal nerve block (with 20ml of %0.25 isobaric bupivacaine) just before surgery is initiated.

    Procedure: Spinal Anesthesia
    All patients will be administered 3ml of %0.5 bupivacaine through L3-L4 interspace to acquire motor and sensory blockade
    Other Names:
  • Spinal Block

    • Procedure: Ilioinguinal Nerve Block
    Analgesic intervention which will be performed only to Ilioinguinal Nerve Block arm. It requires 10ml of %0.25 bupivacaine administration through a 22 G. x 3-1/8 in. (80 mm) Insulated Echogenic Needle with 30° Bevel between umbilicus and iliac crest where the nerve is detected with ultrasound guidance
    Other Names:
  • IIN Block

    • Drug: Bupivacaine %0.5 (hyperbaric)
    Other Names:
  • Heavy bupivacaine

    • Drug: Bupivacaine %0.25 (isobaric)
    Other Names:
  • Plain bupivacaine

    • Device: 25G Quincke needle

    Device: Echogenic Needle with 30° bevel

    Drug: Acetaminophen
    Analgesic drug administration through iv and im route postoperatively. Patients are administered iv acetaminophen 1g twice a day routinely
    Other Names:
  • Analgesics

    • Drug: Tramadol
    Patients will be administered tramadol in postoperative period when their pain score exceeds 4 points (moderate pain)
    Other Names:
  • Analgesics

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Pain Assessment with Verbal Descriptor Scale (VDS) [Baseline]

    2. Pain Assessment with Verbal Descriptor Scale (VDS) [2nd hour after surgery]

    3. Pain Assessment with Verbal Descriptor Scale (VDS) [4th hour after surgery]

    4. Pain Assessment with Verbal Descriptor Scale (VDS) [6th hour after surgery]

    5. Pain Assessment with Verbal Descriptor Scale (VDS) [1st day after surgery]

    6. Pain Assessment with Verbal Descriptor Scale (VDS) [2nd day after surgery]

    7. Pain Assessment with Verbal Descriptor Scale (VDS) [1st month after surgery]

    Secondary Outcome Measures

    1. Complications (Assessment for existence of complications related to procedures in form of Y/N (such as hypotension, bradycardia, arrythmia, hematoma, failed block, nausea, vomiting, urinary retention, headache, back pain)) [Baseline]

      Assessment for existence of complications related to procedures (such as hypotension, bradycardia, arrythmia, hematoma, failed block, nausea, vomiting, urinary retention, headache, back pain)

    2. Complications (Assessment for existence of complications related to procedures in form of Y/N (such as hypotension, bradycardia, arrythmia, hematoma, failed block, nausea, vomiting, urinary retention, headache, back pain)) [2nd hour after surgery]

      Assessment for existence of complications related to procedures (such as hypotension, bradycardia, arrythmia, hematoma, failed block, nausea, vomiting, urinary retention, headache, back pain)

    3. Complications (Assessment for existence of complications related to procedures in form of Y/N (such as hypotension, bradycardia, arrythmia, hematoma, failed block, nausea, vomiting, urinary retention, headache, back pain)) [4th hour after surgery]

      Assessment for existence of complications related to procedures (such as hypotension, bradycardia, arrythmia, hematoma, failed block, nausea, vomiting, urinary retention, headache, back pain)

    4. Complications (Assessment for existence of complications related to procedures in form of Y/N (such as hypotension, bradycardia, arrythmia, hematoma, failed block, nausea, vomiting, urinary retention, headache, back pain)) [6th hour after surgery]

      Assessment for existence of complications related to procedures (such as hypotension, bradycardia, arrythmia, hematoma, failed block, nausea, vomiting, urinary retention, headache, back pain)

    5. Complications (Assessment for existence of complications related to procedures in form of Y/N (such as hypotension, bradycardia, arrythmia, hematoma, failed block, nausea, vomiting, urinary retention, headache, back pain)) [1st day after surgery]

      Assessment for existence of complications related to procedures (such as hypotension, bradycardia, arrythmia, hematoma, failed block, nausea, vomiting, urinary retention, headache, back pain)

    6. Complications (Assessment for existence of complications related to procedures in form of Y/N (such as hypotension, bradycardia, arrythmia, hematoma, failed block, nausea, vomiting, urinary retention, headache, back pain)) [2nd day after surgery]

      Assessment for existence of complications related to procedures (such as hypotension, bradycardia, arrythmia, hematoma, failed block, nausea, vomiting, urinary retention, headache, back pain)

    7. Complications (Assessment for existence of complications related to procedures in form of Y/N (such as hypotension, bradycardia, arrythmia, hematoma, failed block, nausea, vomiting, urinary retention, headache, back pain)) [1st month after surgery]

      Assessment for existence of complications related to procedures (such as hypotension, bradycardia, arrythmia, hematoma, failed block, nausea, vomiting, urinary retention, headache, back pain)

    8. First pain perception in postoperative period (The time when the patients experience pain perception after surgery for the first time) [whenever in 48 hours after surgery]

      The time when the patients experience pain perception after surgery for the first time

    9. Additional analgesic requirements [Baseline]

      Assessment of additional analgesic requirements of patients defined as having a VDS (Verbal Descriptor Scale) greater than 4 (more intense than mild yet lower than moderate)

    10. Additional analgesic requirements [2nd hour after surgery]

      Assessment of additional analgesic requirements of patients defined as having a VDS (Verbal Descriptor Scale) greater than 4 (more intense than mild yet lower than moderate)

    11. Additional analgesic requirements [4th hour after surgery]

      Assessment of additional analgesic requirements of patients defined as having a VDS (Verbal Descriptor Scale) greater than 4 (more intense than mild yet lower than moderate)

    12. Additional analgesic requirements [6th hour after surgery]

      Assessment of additional analgesic requirements of patients defined as having a VDS (Verbal Descriptor Scale) greater than 4 (more intense than mild yet lower than moderate)

    13. Additional analgesic requirements [1st day after surgery]

      Assessment of additional analgesic requirements of patients defined as having a VDS (Verbal Descriptor Scale) greater than 4 (more intense than mild yet lower than moderate)

    14. Additional analgesic requirements [2nd day after surgery]

      Assessment of additional analgesic requirements of patients defined as having a VDS (Verbal Descriptor Scale) greater than 4 (more intense than mild yet lower than moderate)

    15. Additional analgesic requirements [1st month after surgery]

      Assessment of additional analgesic requirements of patients defined as having a VDS (Verbal Descriptor Scale) greater than 4 (more intense than mild yet lower than moderate)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • patients over 18 years old

    • having ASA (American Society of Anesthesiologists) 1 or 2 physical status score preoperatively

    • not having a neuromuscular disease

    • scheduled for elective single sided inguinal herniorraphy operation

    Exclusion Criteria:

    • being under 18 years of age

    • patient refusal

    • having a neuromuscular disease or sensorial neurological deficit covering similar area of effect with peripheral nerve block interventions or the surgical site

    • having ASA 3 or 4 physical status score preoperatively

    • having one of the contraindications to spinal anesthesia and/or to peripheral nerve blocks as listed by NYSORA (New York School of Regional Anesthesia)

    • having emergency surgery or scheduled for bilateral inguinal herniorraphy

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Izmir Bozyaka Training and Research Hospital Izmir Turkey 35170

    Sponsors and Collaborators

    • Bozyaka Training and Research Hospital

    Investigators

    • Principal Investigator: Onur Okur, MD,Resident, Izmir Bozyaka Training and Research Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Bozyaka Training and Research Hospital
    ClinicalTrials.gov Identifier:
    NCT02375100
    Other Study ID Numbers:
    • IzmirBoyaka
    First Posted:
    Mar 2, 2015
    Last Update Posted:
    Oct 28, 2015
    Last Verified:
    Oct 1, 2015
    Additional relevant MeSH terms:
    Pain, Postoperative
    Acetaminophen
    Tramadol
    Analgesics
    Bupivacaine

    Study Results

    No Results Posted as of Oct 28, 2015