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

Study Overview
=================
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.

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

Conditions
-----------------
Pain, Postoperative

Intervention / Treatment
-----------------
* 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


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intrathecal bupivacaine&analgesics<br>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<br>* All patients will be administered 3ml of %0.5 bupivacaine through L3-L4 interspace to acquire motor and sensory blockade<br>* Other names: Spinal Block;Drug: Bupivacaine %0.5 (hyperbaric)<br> <br> * Other names: Heavy bupivacaine;Device: 25G Quincke needle<br> <br> Drug: Acetaminophen<br>* Analgesic drug administration through iv and im route postoperatively. Patients are administered iv acetaminophen 1g twice a day routinely<br>* Other names: Analgesics;Drug: Tramadol<br>* Patients will be administered tramadol in postoperative period when their pain score exceeds 4 points (moderate pain)<br>* Other names: Analgesics;|
| Experimental: TAP Block with bupivacaine<br>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<br>* All patients will be administered 3ml of %0.5 bupivacaine through L3-L4 interspace to acquire motor and sensory blockade<br>* Other names: Spinal Block;Procedure: Transversus Abdominis Plane Block<br>* 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<br>* Other names: TAP block;Drug: Bupivacaine %0.5 (hyperbaric)<br> <br> * Other names: Heavy bupivacaine;Drug: Bupivacaine %0.25 (isobaric)<br> <br> * Other names: Plain bupivacaine;Device: 25G Quincke needle<br> <br> Device: Echogenic Needle with 30° bevel<br> <br> Drug: Acetaminophen<br>* Analgesic drug administration through iv and im route postoperatively. Patients are administered iv acetaminophen 1g twice a day routinely<br>* Other names: Analgesics;Drug: Tramadol<br>* Patients will be administered tramadol in postoperative period when their pain score exceeds 4 points (moderate pain)<br>* Other names: Analgesics;|
| Experimental: IlNB with bupivacaine<br>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<br>* All patients will be administered 3ml of %0.5 bupivacaine through L3-L4 interspace to acquire motor and sensory blockade<br>* Other names: Spinal Block;Procedure: Ilioinguinal Nerve Block<br>* 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<br>* Other names: IIN Block;Drug: Bupivacaine %0.5 (hyperbaric)<br> <br> * Other names: Heavy bupivacaine;Drug: Bupivacaine %0.25 (isobaric)<br> <br> * Other names: Plain bupivacaine;Device: 25G Quincke needle<br> <br> Device: Echogenic Needle with 30° bevel<br> <br> Drug: Acetaminophen<br>* Analgesic drug administration through iv and im route postoperatively. Patients are administered iv acetaminophen 1g twice a day routinely<br>* Other names: Analgesics;Drug: Tramadol<br>* Patients will be administered tramadol in postoperative period when their pain score exceeds 4 points (moderate pain)<br>* Other names: Analgesics;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Assessment with Verbal Descriptor Scale (VDS) |  | Baseline | 
| Pain Assessment with Verbal Descriptor Scale (VDS) |  | 2nd hour after surgery | 
| Pain Assessment with Verbal Descriptor Scale (VDS) |  | 4th hour after surgery | 
| Pain Assessment with Verbal Descriptor Scale (VDS) |  | 6th hour after surgery | 
| Pain Assessment with Verbal Descriptor Scale (VDS) |  | 1st day after surgery | 
| Pain Assessment with Verbal Descriptor Scale (VDS) |  | 2nd day after surgery | 
| Pain Assessment with Verbal Descriptor Scale (VDS) |  | 1st month after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | Baseline | 
| 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) | 2nd hour after surgery | 
| 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) | 4th hour after surgery | 
| 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) | 6th hour after surgery | 
| 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) | 1st day after surgery | 
| 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) | 2nd day after surgery | 
| 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) | 1st month after surgery | 
| 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 | whenever in 48 hours after surgery | 
| 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) | Baseline | 
| 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) | 2nd hour after surgery | 
| 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) | 4th hour after surgery | 
| 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) | 6th hour after surgery | 
| 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) | 1st day after surgery | 
| 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) | 2nd day after surgery | 
| 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) | 1st month after surgery |