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

Pain, Postoperative Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02375100
• Other study ID #: IzmirBoyaka
• Status: Completed
• Phase: N/A
• First received: February 19, 2015
• Last updated: October 27, 2015
• Start date: February 2015
• Est. completion date: October 2015

Study information

• Verified date: October 2015
• Source: Bozyaka Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain, Postoperative

Intervention

Procedure:
• Spinal Anesthesia
All patients will be administered 3ml of %0.5 bupivacaine through L3-L4 interspace to acquire motor and sensory blockade
• 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
• 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

Drug:
• Bupivacaine %0.5 (hyperbaric)

• Bupivacaine %0.25 (isobaric)

Device:
• 25G Quincke needle

• Echogenic Needle with 30° bevel

Drug:
• Acetaminophen
Analgesic drug administration through iv and im route postoperatively. Patients are administered iv acetaminophen 1g twice a day routinely
• Tramadol
Patients will be administered tramadol in postoperative period when their pain score exceeds 4 points (moderate pain)

Locations

Country	Name	City	State
Turkey	Izmir Bozyaka Training and Research Hospital	Izmir

Sponsors (1)

Lead Sponsor	Collaborator
Bozyaka Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Assessment with Verbal Descriptor Scale (VDS)		Baseline	No
Primary	Pain Assessment with Verbal Descriptor Scale (VDS)		2nd hour after surgery	No
Primary	Pain Assessment with Verbal Descriptor Scale (VDS)		4th hour after surgery	No
Primary	Pain Assessment with Verbal Descriptor Scale (VDS)		6th hour after surgery	No
Primary	Pain Assessment with Verbal Descriptor Scale (VDS)		1st day after surgery	No
Primary	Pain Assessment with Verbal Descriptor Scale (VDS)		2nd day after surgery	No
Primary	Pain Assessment with Verbal Descriptor Scale (VDS)		1st month after surgery	No
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No