Postoperative Effects of TAP Block Versus QLB Type 2 Block

Phase 4

Completed

• Conditions: Inguinal Hernia; Postoperative Pain
• Interventions: Drug: Acetaminophen; Drug: 0.5% Bupivacaine+Glucose; Drug: Tramadol HCl; Drug: 0.25% Bupivacaine; Procedure: Inguinal Hernia Repair

• Registration Number: NCT03126084
• Lead Sponsor: Bozyaka Training and Research Hospital

Brief Summary

This study compares analgesic effectiveness of transversus abdominis plane block and quadratus lumborum block type 2 in open hernia repair surgery. All of the patients will receive routine intravenous analgesic regimen. In addition to that one-third of the patients will receive transversus abdominis plane block, one-third will receive quadratus lumborum block type 2. One-third of the patients will not receive any blocks and will constitute the control group

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-04-20
• Study First Submitted QC: 2017-04-20
• Study First Posted: 2017-04-24
• Study Start: 2017-05-02
• Status Verified: 2017-11
• Primary Completion: 2017-11-11
• Study Completion: 2017-11-11
• Last Update Submitted: 2017-11-11
• Last Update Posted: 2017-11-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• Patients who are over 18 years of age
• Patients who are scheduled for elective unilateral open hernia repair with tension free mesh techniques
• Patients who are in ASA's physical status score group 1 or 2

Exclusion Criteria

• Patients who are younger than 18 years of age
• Patients who have severe stenotic heart diseases
• Patients who have bleeding diathesis
• Patients who have true allergies to local anesthetics
• Patients who have neurologic deficits corresponding to effect site of the anesthetic techniques

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
QLB2	0.25% Bupivacaine	Patients will undergo inguinal hernia repair under subarachnoid block with 0.5% bupivacaine+glucose. Patients will receive quadratus lumborum type 2 block with 20 ml of %0.25 bupivacaine preoperatively, in addition to intravenous acetaminophen 1000mg twice a day for postoperative analgesia. Tramadol HCl 50mg intramuscular will be provided for salvage analgesia postoperatively.
TAP	Inguinal Hernia Repair	Patients will undergo inguinal hernia repair under subarachnoid block with 0.5% bupivacaine+glucose. Patients will receive transversus abdominis plane block with 20 ml of 0.25% bupivacaine preoperatively, in addition to intravenous acetaminophen 1000mg twice a day for postoperative analgesia. Tramadol HCl 50mg intramuscular will be provided for salvage analgesia postoperatively.
CONT	Inguinal Hernia Repair	Patients will undergo inguinal hernia repair under subarachnoid block with 0.5% bupivacaine+glucose. Patients will receive intravenous acetaminophen 1000mg twice a day for postoperative analgesia. Tramadol HCl 50mg intramuscular will be provided for salvage analgesia postoperatively.
TAP	0.25% Bupivacaine	Patients will undergo inguinal hernia repair under subarachnoid block with 0.5% bupivacaine+glucose. Patients will receive transversus abdominis plane block with 20 ml of 0.25% bupivacaine preoperatively, in addition to intravenous acetaminophen 1000mg twice a day for postoperative analgesia. Tramadol HCl 50mg intramuscular will be provided for salvage analgesia postoperatively.
TAP	0.5% Bupivacaine+Glucose	Patients will undergo inguinal hernia repair under subarachnoid block with 0.5% bupivacaine+glucose. Patients will receive transversus abdominis plane block with 20 ml of 0.25% bupivacaine preoperatively, in addition to intravenous acetaminophen 1000mg twice a day for postoperative analgesia. Tramadol HCl 50mg intramuscular will be provided for salvage analgesia postoperatively.
QLB2	0.5% Bupivacaine+Glucose	Patients will undergo inguinal hernia repair under subarachnoid block with 0.5% bupivacaine+glucose. Patients will receive quadratus lumborum type 2 block with 20 ml of %0.25 bupivacaine preoperatively, in addition to intravenous acetaminophen 1000mg twice a day for postoperative analgesia. Tramadol HCl 50mg intramuscular will be provided for salvage analgesia postoperatively.
QLB2	Inguinal Hernia Repair	Patients will undergo inguinal hernia repair under subarachnoid block with 0.5% bupivacaine+glucose. Patients will receive quadratus lumborum type 2 block with 20 ml of %0.25 bupivacaine preoperatively, in addition to intravenous acetaminophen 1000mg twice a day for postoperative analgesia. Tramadol HCl 50mg intramuscular will be provided for salvage analgesia postoperatively.
CONT	0.5% Bupivacaine+Glucose	Patients will undergo inguinal hernia repair under subarachnoid block with 0.5% bupivacaine+glucose. Patients will receive intravenous acetaminophen 1000mg twice a day for postoperative analgesia. Tramadol HCl 50mg intramuscular will be provided for salvage analgesia postoperatively.
TAP	Acetaminophen	Patients will undergo inguinal hernia repair under subarachnoid block with 0.5% bupivacaine+glucose. Patients will receive transversus abdominis plane block with 20 ml of 0.25% bupivacaine preoperatively, in addition to intravenous acetaminophen 1000mg twice a day for postoperative analgesia. Tramadol HCl 50mg intramuscular will be provided for salvage analgesia postoperatively.
TAP	Tramadol HCl	Patients will undergo inguinal hernia repair under subarachnoid block with 0.5% bupivacaine+glucose. Patients will receive transversus abdominis plane block with 20 ml of 0.25% bupivacaine preoperatively, in addition to intravenous acetaminophen 1000mg twice a day for postoperative analgesia. Tramadol HCl 50mg intramuscular will be provided for salvage analgesia postoperatively.
QLB2	Acetaminophen	Patients will undergo inguinal hernia repair under subarachnoid block with 0.5% bupivacaine+glucose. Patients will receive quadratus lumborum type 2 block with 20 ml of %0.25 bupivacaine preoperatively, in addition to intravenous acetaminophen 1000mg twice a day for postoperative analgesia. Tramadol HCl 50mg intramuscular will be provided for salvage analgesia postoperatively.
QLB2	Tramadol HCl	Patients will undergo inguinal hernia repair under subarachnoid block with 0.5% bupivacaine+glucose. Patients will receive quadratus lumborum type 2 block with 20 ml of %0.25 bupivacaine preoperatively, in addition to intravenous acetaminophen 1000mg twice a day for postoperative analgesia. Tramadol HCl 50mg intramuscular will be provided for salvage analgesia postoperatively.
CONT	Acetaminophen	Patients will undergo inguinal hernia repair under subarachnoid block with 0.5% bupivacaine+glucose. Patients will receive intravenous acetaminophen 1000mg twice a day for postoperative analgesia. Tramadol HCl 50mg intramuscular will be provided for salvage analgesia postoperatively.
CONT	Tramadol HCl	Patients will undergo inguinal hernia repair under subarachnoid block with 0.5% bupivacaine+glucose. Patients will receive intravenous acetaminophen 1000mg twice a day for postoperative analgesia. Tramadol HCl 50mg intramuscular will be provided for salvage analgesia postoperatively.

Primary Outcome Measures

Name	Time	Method
Pain Intensity	48 hours after surgery	Postoperative pain intensity according Numeric Rating Scale between 0-10 (0=no pain, 10=worst pain ever

Trial Locations

Locations (1)

Izmir Bozyaka Training and Research Hospital; 🇹🇷 Izmir, Turkey