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

NCT ID: NCT02375100

Last Updated: 2015-10-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-02-28
• Study Completion Date: 2015-10-31

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.

Conditions

Pain, Postoperative

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Spinal Anesthesia

Intervention Type: PROCEDURE

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

Bupivacaine %0.5 (hyperbaric)

Intervention Type: DRUG

25G Quincke needle

Intervention Type: DEVICE

Acetaminophen

Intervention Type: DRUG

Analgesic drug administration through iv and im route postoperatively. Patients are administered iv acetaminophen 1g twice a day routinely

Tramadol

Intervention Type: DRUG

Patients will be administered tramadol in postoperative period when their pain score exceeds 4 points (moderate pain)

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.

Group Type: EXPERIMENTAL

Spinal Anesthesia

Intervention Type: PROCEDURE

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

Transversus Abdominis Plane Block

Intervention Type: PROCEDURE

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

Bupivacaine %0.5 (hyperbaric)

Intervention Type: DRUG

Bupivacaine %0.25 (isobaric)

Intervention Type: DRUG

25G Quincke needle

Intervention Type: DEVICE

Echogenic Needle with 30° bevel

Intervention Type: DEVICE

Acetaminophen

Intervention Type: DRUG

Analgesic drug administration through iv and im route postoperatively. Patients are administered iv acetaminophen 1g twice a day routinely

Tramadol

Intervention Type: DRUG

Patients will be administered tramadol in postoperative period when their pain score exceeds 4 points (moderate pain)

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.

Group Type: EXPERIMENTAL

Spinal Anesthesia

Intervention Type: PROCEDURE

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

Ilioinguinal Nerve Block

Intervention Type: PROCEDURE

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

Bupivacaine %0.5 (hyperbaric)

Intervention Type: DRUG

Bupivacaine %0.25 (isobaric)

Intervention Type: DRUG

25G Quincke needle

Intervention Type: DEVICE

Echogenic Needle with 30° bevel

Intervention Type: DEVICE

Acetaminophen

Intervention Type: DRUG

Analgesic drug administration through iv and im route postoperatively. Patients are administered iv acetaminophen 1g twice a day routinely

Tramadol

Intervention Type: DRUG

Patients will be administered tramadol in postoperative period when their pain score exceeds 4 points (moderate pain)

Interventions

Spinal Anesthesia

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

Intervention Type: 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

Intervention Type: 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

Intervention Type: PROCEDURE

Bupivacaine %0.5 (hyperbaric)

Intervention Type: DRUG

Bupivacaine %0.25 (isobaric)

Intervention Type: DRUG

25G Quincke needle

Intervention Type: DEVICE

Echogenic Needle with 30° bevel

Intervention Type: DEVICE

Acetaminophen

Analgesic drug administration through iv and im route postoperatively. Patients are administered iv acetaminophen 1g twice a day routinely

Intervention Type: DRUG

Tramadol

Patients will be administered tramadol in postoperative period when their pain score exceeds 4 points (moderate pain)

Intervention Type: DRUG

Other Intervention Names

Spinal Block; TAP block; IIN Block; Heavy bupivacaine; Plain bupivacaine; Analgesics; Analgesics

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bozyaka Training and Research Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Onur Okur, MD,Resident

Role: PRINCIPAL_INVESTIGATOR

Izmir Bozyaka Training and Research Hospital

Locations

Izmir Bozyaka Training and Research Hospital

Izmir, İzmir, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

IzmirBoyaka

Identifier Type: -

Identifier Source: org_study_id