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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03126084
Other study ID # ANES-QLB-0609
Secondary ID
Status Completed
Phase Phase 4
First received April 20, 2017
Last updated November 11, 2017
Start date May 2, 2017
Est. completion date November 11, 2017

Study information

Verified date November 2017
Source Bozyaka Training and Research Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


Recruitment information / eligibility

Status Completed
Enrollment 90
Est. completion date November 11, 2017
Est. primary completion date November 11, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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


Intervention

Drug:
Acetaminophen
1000 mg of intravenous acetaminophen will be administered twice a day
0.25% Bupivacaine
20 ml of 0.25% bupivacaine will be administered to the fascia of the transversus abdominis muscle under ultrasound guidance.
0.5% Bupivacaine+Glucose
15mg of 0.5% bupivacaine will be administered to subarachnoid space through 25G spinal needle
Tramadol HCl
50mg of intramuscular tramadol will be administered when pain score is greater than 3 according to NRS
Procedure:
Inguinal Hernia Repair
Patients will undergo open inguinal hernia repair with one of the tension free mesh techniques
Drug:
0.25% Bupivacaine
10 ml 0.25% bupivacaine will be administered quadratus lumborum muscle and erector spinae muscle

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, 

References & Publications (3)

Bærentzen F, Maschmann C, Jensen K, Belhage B, Hensler M, Børglum J. Ultrasound-guided nerve block for inguinal hernia repair: a randomized, controlled, double-blind study. Reg Anesth Pain Med. 2012 Sep-Oct;37(5):502-7. doi: 10.1097/AAP.0b013e31825a3c8a. — View Citation

Finnerty O, Carney J, McDonnell JG. Trunk blocks for abdominal surgery. Anaesthesia. 2010 Apr;65 Suppl 1:76-83. doi: 10.1111/j.1365-2044.2009.06203.x. Review. — View Citation

McDonnell JG, O'Donnell B, Curley G, Heffernan A, Power C, Laffey JG. The analgesic efficacy of transversus abdominis plane block after abdominal surgery: a prospective randomized controlled trial. Anesth Analg. 2007 Jan;104(1):193-7. Erratum in: Anesth Analg. 2007 May;104(5):1108. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Pain Intensity Postoperative pain intensity according Numeric Rating Scale between 0-10 (0=no pain, 10=worst pain ever 24 hours after surgery
Primary Pain Intensity Postoperative pain intensity according Numeric Rating Scale between 0-10 (0=no pain, 10=worst pain ever) 2 hours after surgery
Primary Pain Intensity Postoperative pain intensity according Numeric Rating Scale between 0-10 (0=no pain, 10=worst pain ever 6 hours after surgery
Primary Pain Intensity Postoperative pain intensity according Numeric Rating Scale between 0-10 (0=no pain, 10=worst pain ever 48 hours after surgery
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