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

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ClinicalTrials.gov Identifier: NCT02375100
Recruitment Status : Completed
First Posted : March 2, 2015
Last Update Posted : October 28, 2015
Sponsor:
Information provided by (Responsible Party):
Bozyaka Training and Research Hospital

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
Pain, Postoperative 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 Not Applicable

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Study Type : Interventional  (Clinical Trial)
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 : February 2015
Actual Primary Completion Date : October 2015
Actual Study Completion Date : October 2015

Resource links provided by the National Library of Medicine


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 Name: Spinal Block

Drug: Bupivacaine %0.5 (hyperbaric)
Other Name: 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 Name: Analgesics

Drug: Tramadol
Patients will be administered tramadol in postoperative period when their pain score exceeds 4 points (moderate pain)
Other Name: 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 Name: 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 Name: TAP block

Drug: Bupivacaine %0.5 (hyperbaric)
Other Name: Heavy bupivacaine

Drug: Bupivacaine %0.25 (isobaric)
Other Name: 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 Name: Analgesics

Drug: Tramadol
Patients will be administered tramadol in postoperative period when their pain score exceeds 4 points (moderate pain)
Other Name: 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 Name: 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 Name: IIN Block

Drug: Bupivacaine %0.5 (hyperbaric)
Other Name: Heavy bupivacaine

Drug: Bupivacaine %0.25 (isobaric)
Other Name: 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 Name: Analgesics

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




Primary Outcome Measures :
  1. Pain Assessment with Verbal Descriptor Scale (VDS) [ Time Frame: Baseline ]
  2. Pain Assessment with Verbal Descriptor Scale (VDS) [ Time Frame: 2nd hour after surgery ]
  3. Pain Assessment with Verbal Descriptor Scale (VDS) [ Time Frame: 4th hour after surgery ]
  4. Pain Assessment with Verbal Descriptor Scale (VDS) [ Time Frame: 6th hour after surgery ]
  5. Pain Assessment with Verbal Descriptor Scale (VDS) [ Time Frame: 1st day after surgery ]
  6. Pain Assessment with Verbal Descriptor Scale (VDS) [ Time Frame: 2nd day after surgery ]
  7. Pain Assessment with Verbal Descriptor Scale (VDS) [ Time Frame: 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)) [ Time Frame: 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)) [ Time Frame: 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)) [ Time Frame: 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)) [ Time Frame: 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)) [ Time Frame: 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)) [ Time Frame: 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)) [ Time Frame: 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) [ Time Frame: whenever in 48 hours after surgery ]
    The time when the patients experience pain perception after surgery for the first time

  9. Additional analgesic requirements [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02375100


Locations
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Turkey
Izmir Bozyaka Training and Research Hospital
Izmir, Turkey, 35170
Sponsors and Collaborators
Bozyaka Training and Research Hospital
Investigators
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Principal Investigator: Onur Okur, MD,Resident Izmir Bozyaka Training and Research Hospital

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Responsible Party: Bozyaka Training and Research Hospital
ClinicalTrials.gov Identifier: NCT02375100    
Other Study ID Numbers: IzmirBoyaka
First Posted: March 2, 2015    Key Record Dates
Last Update Posted: October 28, 2015
Last Verified: October 2015
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Acetaminophen
Tramadol
Anesthetics
Bupivacaine
Analgesics
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Local
Sensory System Agents
Peripheral Nervous System Agents
Analgesics, Non-Narcotic
Antipyretics
Analgesics, Opioid
Narcotics