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Clinical Trials/NCT02375100
NCT02375100
Completed
N/A

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

Bozyaka Training and Research Hospital1 site in 1 country90 target enrollmentFebruary 2015

Overview

Phase
N/A
Intervention
Spinal Anesthesia
Conditions
Pain, Postoperative
Sponsor
Bozyaka Training and Research Hospital
Enrollment
90
Locations
1
Primary Endpoint
Pain Assessment with Verbal Descriptor Scale (VDS)
Status
Completed
Last Updated
10 years ago

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.

Registry
clinicaltrials.gov
Start Date
February 2015
End Date
October 2015
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Bozyaka Training and Research Hospital
Responsible Party
Sponsor

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

Arms & Interventions

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.

Intervention: Spinal Anesthesia

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.

Intervention: Bupivacaine %0.5 (hyperbaric)

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.

Intervention: 25G Quincke needle

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.

Intervention: Acetaminophen

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.

Intervention: Tramadol

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.

Intervention: Spinal Anesthesia

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.

Intervention: Transversus Abdominis Plane Block

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.

Intervention: Bupivacaine %0.5 (hyperbaric)

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.

Intervention: Bupivacaine %0.25 (isobaric)

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.

Intervention: 25G Quincke needle

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.

Intervention: Echogenic Needle with 30° bevel

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.

Intervention: Acetaminophen

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.

Intervention: Tramadol

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.

Intervention: Spinal Anesthesia

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.

Intervention: Ilioinguinal Nerve Block

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.

Intervention: Bupivacaine %0.5 (hyperbaric)

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.

Intervention: Bupivacaine %0.25 (isobaric)

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.

Intervention: 25G Quincke needle

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.

Intervention: Echogenic Needle with 30° bevel

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.

Intervention: Acetaminophen

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.

Intervention: Tramadol

Outcomes

Primary Outcomes

Pain Assessment with Verbal Descriptor Scale (VDS)

Time Frame: 1st month after surgery

Secondary Outcomes

  • 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)
  • Additional analgesic requirements(1st month 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))(1st month after surgery)

Study Sites (1)

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