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

Primary Purpose

Pain, Postoperative

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Spinal Anesthesia
Transversus Abdominis Plane Block
Ilioinguinal Nerve Block
Bupivacaine %0.5 (hyperbaric)
Bupivacaine %0.25 (isobaric)
25G Quincke needle
Echogenic Needle with 30° bevel
Acetaminophen
Tramadol
Sponsored by
Bozyaka Training and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Postoperative

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Izmir Bozyaka Training and Research Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Intrathecal bupivacaine&analgesics

TAP Block with bupivacaine

IlNB with bupivacaine

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Pain Assessment with Verbal Descriptor Scale (VDS)
Pain Assessment with Verbal Descriptor Scale (VDS)
Pain Assessment with Verbal Descriptor Scale (VDS)
Pain Assessment with Verbal Descriptor Scale (VDS)
Pain Assessment with Verbal Descriptor Scale (VDS)
Pain Assessment with Verbal Descriptor Scale (VDS)
Pain Assessment with Verbal Descriptor Scale (VDS)

Secondary Outcome Measures

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))
Assessment for existence of complications related to procedures (such as hypotension, bradycardia, arrythmia, hematoma, failed block, nausea, vomiting, urinary retention, headache, back pain)
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))
Assessment for existence of complications related to procedures (such as hypotension, bradycardia, arrythmia, hematoma, failed block, nausea, vomiting, urinary retention, headache, back pain)
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))
Assessment for existence of complications related to procedures (such as hypotension, bradycardia, arrythmia, hematoma, failed block, nausea, vomiting, urinary retention, headache, back pain)
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))
Assessment for existence of complications related to procedures (such as hypotension, bradycardia, arrythmia, hematoma, failed block, nausea, vomiting, urinary retention, headache, back pain)
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))
Assessment for existence of complications related to procedures (such as hypotension, bradycardia, arrythmia, hematoma, failed block, nausea, vomiting, urinary retention, headache, back pain)
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))
Assessment for existence of complications related to procedures (such as hypotension, bradycardia, arrythmia, hematoma, failed block, nausea, vomiting, urinary retention, headache, back pain)
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))
Assessment for existence of complications related to procedures (such as hypotension, bradycardia, arrythmia, hematoma, failed block, nausea, vomiting, urinary retention, headache, back pain)
First pain perception in postoperative period (The time when the patients experience pain perception after surgery for the first time)
The time when the patients experience pain perception after surgery for the first time
Additional analgesic requirements
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)
Additional analgesic requirements
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)
Additional analgesic requirements
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)
Additional analgesic requirements
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)
Additional analgesic requirements
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)
Additional analgesic requirements
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)
Additional analgesic requirements
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)

Full Information

First Posted
February 19, 2015
Last Updated
October 27, 2015
Sponsor
Bozyaka Training and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02375100
Brief Title
Transversus Abdominis Plane Block Versus Ilioinguinal Nerve Block for Pain Management in Inguinal Herniorraphy
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 Type
Interventional

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
February 2015 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
October 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bozyaka Training and Research Hospital

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intrathecal bupivacaine&analgesics
Arm Type
Active Comparator
Arm Description
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.
Arm Title
TAP Block with bupivacaine
Arm Type
Experimental
Arm Description
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.
Arm Title
IlNB with bupivacaine
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Spinal Anesthesia
Other Intervention Name(s)
Spinal Block
Intervention Description
All patients will be administered 3ml of %0.5 bupivacaine through L3-L4 interspace to acquire motor and sensory blockade
Intervention Type
Procedure
Intervention Name(s)
Transversus Abdominis Plane Block
Other Intervention Name(s)
TAP block
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
Ilioinguinal Nerve Block
Other Intervention Name(s)
IIN Block
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Bupivacaine %0.5 (hyperbaric)
Other Intervention Name(s)
Heavy bupivacaine
Intervention Type
Drug
Intervention Name(s)
Bupivacaine %0.25 (isobaric)
Other Intervention Name(s)
Plain bupivacaine
Intervention Type
Device
Intervention Name(s)
25G Quincke needle
Intervention Type
Device
Intervention Name(s)
Echogenic Needle with 30° bevel
Intervention Type
Drug
Intervention Name(s)
Acetaminophen
Other Intervention Name(s)
Analgesics
Intervention Description
Analgesic drug administration through iv and im route postoperatively. Patients are administered iv acetaminophen 1g twice a day routinely
Intervention Type
Drug
Intervention Name(s)
Tramadol
Other Intervention Name(s)
Analgesics
Intervention Description
Patients will be administered tramadol in postoperative period when their pain score exceeds 4 points (moderate pain)
Primary Outcome Measure Information:
Title
Pain Assessment with Verbal Descriptor Scale (VDS)
Time Frame
Baseline
Title
Pain Assessment with Verbal Descriptor Scale (VDS)
Time Frame
2nd hour after surgery
Title
Pain Assessment with Verbal Descriptor Scale (VDS)
Time Frame
4th hour after surgery
Title
Pain Assessment with Verbal Descriptor Scale (VDS)
Time Frame
6th hour after surgery
Title
Pain Assessment with Verbal Descriptor Scale (VDS)
Time Frame
1st day after surgery
Title
Pain Assessment with Verbal Descriptor Scale (VDS)
Time Frame
2nd day after surgery
Title
Pain Assessment with Verbal Descriptor Scale (VDS)
Time Frame
1st month after surgery
Secondary Outcome Measure Information:
Title
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))
Description
Assessment for existence of complications related to procedures (such as hypotension, bradycardia, arrythmia, hematoma, failed block, nausea, vomiting, urinary retention, headache, back pain)
Time Frame
Baseline
Title
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))
Description
Assessment for existence of complications related to procedures (such as hypotension, bradycardia, arrythmia, hematoma, failed block, nausea, vomiting, urinary retention, headache, back pain)
Time Frame
2nd hour after surgery
Title
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))
Description
Assessment for existence of complications related to procedures (such as hypotension, bradycardia, arrythmia, hematoma, failed block, nausea, vomiting, urinary retention, headache, back pain)
Time Frame
4th hour after surgery
Title
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))
Description
Assessment for existence of complications related to procedures (such as hypotension, bradycardia, arrythmia, hematoma, failed block, nausea, vomiting, urinary retention, headache, back pain)
Time Frame
6th hour after surgery
Title
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))
Description
Assessment for existence of complications related to procedures (such as hypotension, bradycardia, arrythmia, hematoma, failed block, nausea, vomiting, urinary retention, headache, back pain)
Time Frame
1st day after surgery
Title
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))
Description
Assessment for existence of complications related to procedures (such as hypotension, bradycardia, arrythmia, hematoma, failed block, nausea, vomiting, urinary retention, headache, back pain)
Time Frame
2nd day after surgery
Title
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))
Description
Assessment for existence of complications related to procedures (such as hypotension, bradycardia, arrythmia, hematoma, failed block, nausea, vomiting, urinary retention, headache, back pain)
Time Frame
1st month after surgery
Title
First pain perception in postoperative period (The time when the patients experience pain perception after surgery for the first time)
Description
The time when the patients experience pain perception after surgery for the first time
Time Frame
whenever in 48 hours after surgery
Title
Additional analgesic requirements
Description
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)
Time Frame
Baseline
Title
Additional analgesic requirements
Description
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)
Time Frame
2nd hour after surgery
Title
Additional analgesic requirements
Description
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)
Time Frame
4th hour after surgery
Title
Additional analgesic requirements
Description
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)
Time Frame
6th hour after surgery
Title
Additional analgesic requirements
Description
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)
Time Frame
1st day after surgery
Title
Additional analgesic requirements
Description
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)
Time Frame
2nd day after surgery
Title
Additional analgesic requirements
Description
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)
Time Frame
1st month after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Onur Okur, MD,Resident
Organizational Affiliation
Izmir Bozyaka Training and Research Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Izmir Bozyaka Training and Research Hospital
City
Izmir
ZIP/Postal Code
35170
Country
Turkey

12. IPD Sharing Statement

Learn more about this trial

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

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