Comparison of Postoperative Analgesic Efficacy of Transversalis Fascia Plan Block and Erector Spina Plan Block

NCT05344105 | Completed

• 1 other identifier: SIMAY55
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The subject of the study is to compare the analgesic efficacy of transversalis fascia plan block and erector spina plane block applied with ultrasonography in patients who have undergone inguinal hernia operation. The aim of the study is to compare two different regional anesthesia methods applied in the postoperative period in terms of 24-hour opioid consumption, pain scores, additional analgesic need, and side effects and complications in the postoperative period.

Conditions

Regional Anesthesia

Keywords

regional analgesia; transversalis fascia plane block; erector spina plane block

Outcome Measures

Primary Outcomes (1)

• Opioid use

  To determine the amount of analgesic consumption in the postoperative first 24 hours with PCA in the postoperative period.

  Postoperative 24 hours

Secondary Outcomes (1)

• Numerical Rating Scale

  Postoperative 24 hours

Study Arms (2)

Transversalis fascia plan block (Group T)

ACTIVE COMPARATOR

After local cleaning of the skin area, the transducer will be placed on the iliac crest in the transverse plane with a low-frequency convex probe, and the skin, subcutaneous tissue, external oblique muscle will be placed with a 20 G, 100 mm needle. After visualization of the internal oblique muscle and transversus abdominis muscles and finally the deep fascia of the transversus abdominis, local anesthetic will be given unilaterally between the last part of the transversus abdominis muscle and the transversalis fascia with the out-off plan technique.

Device: Low frequency convex probe (ESAOTE Fixed Color Doppler Ultrasonography Device, Italy)

Erector spina plan block (Group E)

ACTIVE COMPARATOR

After local cleaning of the skin area, a convex probe is determined to be placed longitudinally 3 cm lateral to the spinous process of the T11 vertebra, after determining the erector spina muscle, with a 20 G, 100 mm needle inplane method in the craniocaudal direction will be advanced and a local anesthetic will be administered between the erector spinae muscle and the transverse process.

Device: Low frequency convex probe (ESAOTE Fixed Color Doppler Ultrasonography Device, Italy)

Interventions

Low frequency convex probe (ESAOTE Fixed Color Doppler Ultrasonography Device, Italy) DEVICE

A low frequency convex probe (ESAOTE Fixed Color Doppler Ultrasonography Device, Italy) device will be used while blocking in both groups.

Erector spina plan block (Group E); Transversalis fascia plan block (Group T)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Those who underwent unilateral inguinal hernia surgery under elective conditions
• years
• ASA I-III
• Patients with written consent who agreed to participate in the study

You may not qualify if:

• Body mass index \> 35 kg/m²,
• Coagulopathy and local infection or hematoma in the area to be blocked,
• Allergic to a local anesthetic agent or one of the drugs used in the study,
• Those with a history of chronic opioid and corticosteroid use,
• Unable to use the patient-controlled analgesia system,
• Those with psychiatric illness,
• Cases with a surgical time of less than 30 minutes and more than 120 minutes for better standardization of studies,
• Patients who do not agree to participate in the study will not be included in the study.

Sponsors & Collaborators

• Samsun Education and Research Hospital: lead

Study Sites (1)

Samsun Research and Education Hospital

Samsun, 55090, Turkey (Türkiye)

Location

Related Publications (4)

• El-Emam EM, El Motlb EAA. Ultrasound-Guided Erector Spinae versus Ilioinguinal/Iliohypogastric Block for Postoperative Analgesia in Children Undergoing Inguinal Surgeries. Anesth Essays Res. 2019 Apr-Jun;13(2):274-279. doi: 10.4103/aer.AER_81_19.

  PMID: 31198244 RESULT

• Tulgar S, Kapakli MS, Senturk O, Selvi O, Serifsoy TE, Ozer Z. Evaluation of ultrasound-guided erector spinae plane block for postoperative analgesia in laparoscopic cholecystectomy: A prospective, randomized, controlled clinical trial. J Clin Anesth. 2018 Sep;49:101-106. doi: 10.1016/j.jclinane.2018.06.019. Epub 2018 Jun 15.

  PMID: 29913392 RESULT

• Fouad AZ, Abdel-Aal IRM, Gadelrab MRMA, Mohammed HMES. Ultrasound-guided transversalis fascia plane block versus transmuscular quadratus lumborum block for post-operative analgesia in inguinal hernia repair. Korean J Pain. 2021 Apr 1;34(2):201-209. doi: 10.3344/kjp.2021.34.2.201.

  PMID: 33785672 RESULT

• Celik HK, Tulgar S, Buk OF, Koc K, Unal M, Genc C, Suren M. Comparison of the analgesic efficacy of the ultrasound-guided transversalis fascia plane block and erector spinae plane block in patients undergoing open inguinal hernia repair under spinal anesthesia. Korean J Anesthesiol. 2024 Apr;77(2):255-264. doi: 10.4097/kja.23404. Epub 2024 Jan 8.

  PMID: 38185619 DERIVED

Study Officials

• Mustafa Suren, Professor

  Samsun Research and Education Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: The patient will not know which study group he is in. The anesthetist, who will perform the regional block, will give the block to be applied in a sealed envelope by an assistant staff outside the study, and at the same time, the patient will not know which block has been made. The anesthesiologist who made the block will not participate in the pain follow-up of the patients. Postoperative pain assessment and data collection will be performed by another investigator blinded to the study.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Anesthesiologist

Study Record Dates

• First Submitted: April 18, 2022
• First Posted: April 25, 2022
• Study Start: May 5, 2022
• Primary Completion: September 1, 2022
• Study Completion: October 1, 2022
• Last Updated: November 10, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)