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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04227912
Other study ID # SBUGaziYasargilTRH
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 11, 2019
Est. completion date October 1, 2019

Study information

Verified date January 2020
Source Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study evaluates the compare the effects of ultrasound guided TAP block, local anesthetic infiltration to the incision line and intravenous dexketoprofen on postoperative analgesic efficacy and rescue tramadol consumption in inguinal hernia repairs.


Description:

Currently, multimodal techniques are used in inguinal hernia repairs in addition to pharmacological and regional techniques for postoperative analgesia.TAP block is performed on the principle of hydrodissection of the fascia between the internal oblique and transversus abdominis muscles of the abdominal wall muscles with local anesthetic drugs. Local anesthetic drugs provide analgesic effect up to 24 hours in the postoperative period by blocking the T6-L1 nerves in the facial plane. Local anesthetic infiltration which is one of the regional anesthetic techniques, is another method of postoperative analgesia. intravenous analgesic drug is also used as pharmacological postoperative analgesia method in most clinics.


Recruitment information / eligibility

Status Completed
Enrollment 120
Est. completion date October 1, 2019
Est. primary completion date October 1, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:

- Subject who aged 18-75 years

- American Society of Anesthesiologist (ASA) I-III

- Subject undergoing unilateral or bilateral inguinal hernia repair

Exclusion Criteria:

- Subject under 18 and over 75 years of age

- ASA IV

- History of allergy to agents

- Analgesic drug use in the last 48 hours

- Morbid obese (BMI> 35)

- Confusion

- Coagulopathy

- Local infection at the injection site

- Subject with heart, lung, hematologic, metabolic and endocrine disease

- Subject who did not want to be included in the study

- Subject who refused the spinal anesthesia

- Subject who failed the spinal anesthesia

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Transversus abdominis plane block
Before surgery, Ultrasound-guided TAP block was performed preemptively to Group TAP patients.
Local anesthetic infiltration
Before surgery, Ultrasound-guided Local anesthetic infiltration to the surgical incision line was performed preemptively to Group Local patients.
Intravenous dexketoprofen
Before surgery, 50 mg intravenous dexketoprofen was performed preemptively to Group dexketoprofen patients.

Locations

Country Name City State
Turkey University of Health Sciences Gazi Yasargil Training and Research Hospital Di?yarbakir Eyalet/Yerleske

Sponsors (1)

Lead Sponsor Collaborator
Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

Joshi GP, Rawal N, Kehlet H; PROSPECT collaboration, Bonnet F, Camu F, Fischer HB, Neugebauer EA, Schug SA, Simanski CJ. Evidence-based management of postoperative pain in adults undergoing open inguinal hernia surgery. Br J Surg. 2012 Feb;99(2):168-85. d — View Citation

Petersen PL, Mathiesen O, Stjernholm P, Kristiansen VB, Torup H, Hansen EG, Mitchell AU, Moeller A, Rosenberg J, Dahl JB. The effect of transversus abdominis plane block or local anaesthetic infiltration in inguinal hernia repair: a randomised clinical tr — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Postoperative rescue tramadol consumption The mean tramadol consumption in the first 24 post-operative hours 24 hours
Secondary Analgesic efficacy Postoperative visual analog scale score recorded 0-10 (0 = no pain, 10 = severe pain) at 30. min, 1, 2, 4, 8, 12, 16 and 24 hours postoperatively 24 hours
Secondary Postoperative nausea-vomiting Postoperative nausea-vomiting was evaluated with a 3-point system (0: no nausea and vomiting, 1: nausea, but no vomiting, 2: nausea with or without nausea) 24 hours postoperatively. 24 hours
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