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

Comparison of Efficacy of Transversus Abdominis Plane Block and Ilioinguinal Nerve Block for Postoperative Pain Management in Patients Undergoing Inguinal Herniorraphy With Spinal Anesthesia

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.

Study Overview

• Status: Completed
• Conditions: Pain, Postoperative
• Intervention / Treatment: Procedure: Spinal Anesthesia; Drug: Bupivacaine %0.5 (hyperbaric); Device: 25G Quincke needle; Drug: Acetaminophen; Drug: Tramadol; Procedure: Transversus Abdominis Plane Block; Drug: Bupivacaine %0.25 (isobaric); Device: Echogenic Needle with 30° bevel; Procedure: Ilioinguinal Nerve Block

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Izmir, Turkey, 35170
    • Izmir Bozyaka Training and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / 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; 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; 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 %0.25 (isobaric); Other Names: Plain bupivacaine; Device: Echogenic Needle with 30° bevel
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; 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; Drug: Bupivacaine %0.25 (isobaric); Other Names: Plain bupivacaine; Device: Echogenic Needle with 30° bevel; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start: February 1, 2015
• Primary Completion (Actual): October 1, 2015
• Study Completion (Actual): October 1, 2015

Study Registration Dates

• First Submitted: February 19, 2015
• First Submitted That Met QC Criteria: February 27, 2015
• First Posted (Estimate): March 2, 2015

Study Record Updates

• Last Update Posted (Estimate): October 28, 2015
• Last Update Submitted That Met QC Criteria: October 27, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Analgesics, Non-Narcotic; Antipyretics; Analgesics, Opioid; Narcotics; Anesthetics, Local; Acetaminophen; Bupivacaine; Tramadol; Analgesics
• Other Study ID Numbers: IzmirBoyaka