Clinical trial NCT02375100: 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
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Postoperative
Lead sponsor: Bozyaka Training and Research Hospital
Sponsor class: OTHER
First posted: 2015-03-02
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Pain Assessment with Verbal Descriptor Scale (VDS)
timeFrame: Baseline
measure: Pain Assessment with Verbal Descriptor Scale (VDS)
timeFrame: 2nd hour after surgery
measure: Pain Assessment with Verbal Descriptor Scale (VDS)
timeFrame: 4th hour after surgery
measure: Pain Assessment with Verbal Descriptor Scale (VDS)
timeFrame: 6th hour after surgery
measure: Pain Assessment with Verbal Descriptor Scale (VDS)
timeFrame: 1st day after surgery
measure: Pain Assessment with Verbal Descriptor Scale (VDS)
timeFrame: 2nd day after surgery
measure: Pain Assessment with Verbal Descriptor Scale (VDS)
timeFrame: 1st month after surgery
Secondary outcomes:
measure: 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))
timeFrame: Baseline
measure: 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))
timeFrame: 2nd hour after surgery
measure: 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))
timeFrame: 4th hour after surgery
measure: 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))
timeFrame: 6th hour after surgery
measure: 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))
timeFrame: 1st day after surgery
measure: 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))
timeFrame: 2nd day after surgery
measure: 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))
timeFrame: 1st month after surgery
measure: First pain perception in postoperative period (The time when the patients experience pain perception after surgery for the first time)
timeFrame: whenever in 48 hours after surgery
measure: Additional analgesic requirements
timeFrame: Baseline
measure: Additional analgesic requirements
timeFrame: 2nd hour after surgery
measure: Additional analgesic requirements
timeFrame: 4th hour after surgery
measure: Additional analgesic requirements
timeFrame: 6th hour after surgery
measure: Additional analgesic requirements
timeFrame: 1st day after surgery
measure: Additional analgesic requirements
timeFrame: 2nd day after surgery
measure: Additional analgesic requirements
timeFrame: 1st month after surgery
Other outcomes:
Locations:
city: Izmir
country: Turkey
facility: Izmir Bozyaka Training and Research Hospital
Study officials:
affiliation: Izmir Bozyaka Training and Research Hospital
name: Onur Okur, MD,Resident
role: PRINCIPAL_INVESTIGATOR
References: