Comparison the Analgesic Efficacy of Ultrasonographic Bilateral TAP and Anesthetic Infiltration Into the Surgery Field for Laparoscopic Unilateral TEP Herniorrhaphy

NCT06894420 | Recruiting

• 1 other identifier: AC2122
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Laparoscopic inguinal hernia repair is a common surgical procedure, but postoperative pain management remains a challenge. This prospective, randomized study aims to compare the analgesic efficacy of preperitoneal and surgical site anesthetic infiltration with ultrasound-guided bilateral transversus abdominis plane (TAP) block in patients undergoing laparoscopic unilateral total extraperitoneal (TEP) herniorrhaphy. Sixty patients will be randomly allocated into two groups: Group-I will receive preperitoneal and surgical site infiltration with bupivacaine, while Group-II will receive ultrasound-guided bilateral TAP block with bupivacaine. The primary outcomes will be postoperative pain scores assessed using the visual analog scale (VAS) and additional analgesic requirements. Secondary outcomes will include postoperative hospital stay duration and cost-effectiveness. Demographic data, ASA scores, comorbidities, and operation times will be recorded. Postoperative pain will be managed with a multimodal approach, including paracetamol and NSAIDs. Rescue analgesia will be provided with intravenous paracetamol. Statistical analysis will be performed using t-tests, ANOVA, Wilcoxon-Mann-Whitney tests, and chi-square tests, as appropriate. This study aims to determine the optimal and most beneficial method for postoperative pain management and patient comfort following laparoscopic inguinal hernia repair.

Conditions

Laparoscopic Surgery; Herniorrhaphy; Inguinal Hernia Unilateral; Transversus Abdominis Plane (TAP) Block; Postoperative Analgesia

Keywords

Laparoscopic surgery; Inguinal hernia; postoperative analgesia; Transversus Abdominis Plane (TAP) Block

Outcome Measures

Primary Outcomes (1)

• Visual Analog Scale

  Visual Analog Scale. It will be used to assess postoperative pain. The degree of pain of the patient will be evaluated with a scoring scale from 1 to 10. 0- No pain...... 10- Intolerable pain.

  24 hours

Study Arms (2)

Surgery Block

ACTIVE COMPARATOR

After obtaining informed consent from the volunteer patients before surgery, the patients will be taken to the operating room, monitored and put to sleep with the general anesthesia procedure that we routinely apply in laparoscopic surgeries. In laparoscopic hernia repairs, patients will be placed in supine position, after appropriate aseptic conditions are provided (the surgical area will be wiped with 10% povidone iodine so that there is no dry area and covered with sterile green drapes). Under general anesthesia, a 1 cm incision will be made 1 cm inferior to the umbilical border, a 10 mm trocar will be inserted into the preperitoneal space and blunt dissection will be performed with a 30 degree camera. After observing the preperitoneal space, two 5 mm working trocars will be placed in the midline 2 cm and 6 cm inferior to the symphysis pubis. The cord structures and Cooper ligament will be exposed and the hernia sac will be freed from the anatomical structures of the cord. Prolene

Procedure: Surgeon-Initiated Local Anesthetic

TAP Block

ACTIVE COMPARATOR

Group-II patients will undergo bilateral TAP block under ultrasound guidance by the anesthesiologist before the patient wakes up after the operation is completed and the skin is sutured. During the block, a Hitachi brand linear USG probe will be sterilized and placed between the iliac wing and costae parallel to the costal margin in the mid-axillary line. Anatomically, skin, subcutaneous tissue, external oblique muscle, internal oblique muscle and transversus abdominis muscle will be visualized. Under USG guidance, a 21G 80 or 100 mm block needle will be advanced from medial to lateral (or lateral to medial) to reach the fascial plane between the internal oblique and transversus abdominis muscles. After confirming the block site by injecting 1-2 ml of 0.09% NaCl after negative aspiration, 15-20 ml (40-50 mg in each quadrant of the abdomen since the block will be performed bilaterally) of bupivacaine 0.5% concentration will be given to the patients in a controlled manner by negative as

Procedure: Transversus abdominis plane (TAP) block

Interventions

Surgeon-Initiated Local Anesthetic PROCEDURE

In laparoscopic hernia repairs, patients are positioned supine, and the surgical area is cleansed with povidone iodine and covered with sterile green drapes. A 1-centimeter incision will be made 1 centimeter below the umbilical border. A 10-mm trocar will be inserted into the preperitoneal space. The operation was filmed from the front with a 30-degree camera. After observing the preperitoneal space, two five-mm working trocars will be placed midline, two and six centimeters inferior to the symphysis pubis. Next, the cord structures and Cooper ligament will be exposed and the hernia sac freed from surrounding anatomical structures.Prolene mesh will be spread over the preperitoneal area to cover all hernia defects and secured to the Cooper ligament and abdominal wall with an absorbable fixation device. Group 1 patients undergo desufflation via 50 mg of bupivacaine into the preperitoneal space, followed by 10 mg of bupivacaine into each trocar incision and skin closure with sutures.

Surgery Block

Transversus abdominis plane (TAP) block PROCEDURE

After the surgery, the anesthesiologist will use a TAP block under ultrasound guidance. Before the patient wakes up, the Hitachi ultrasound probe will be sterilized and positioned between the iliac wing and the costae. An ultrasound shows the skin, fat beneath it, the six abdominal muscle layers, and a support muscle.A thin needle goes through the skin from one side to the other to reach the muscle layers. The location of the block is confirmed by injecting 1-2 ml of 0.09% NaCl followed by negative aspiration. Patients receive 15-20 ml (40-50 mg per quadrant) of bupivacaine 0.5% concentration in a controlled manner with negative aspiration every 5 ml. The block is performed bilaterally.

TAP Block

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Consenting patients,
• She will undergo laparoscopic hernia repair surgery,
• ASA-I-II,
• Between the ages of 18 and 65,
• No history of anticoagulant or antiaggregant drug use,
• Regional anesthesia is not contraindicated and the anesthesiologist deems -appropriate for regional anesthesia,
• Under general anesthesia and will undergo laparoscopic surgery,
• Fully oriented and cooperative,
• Unilateral inguinal hernia,
• No previous surgery for inguinal hernia,
• No incision in the lower abdomen,
• Not using alcohol and drugs,
• No preoperative pain and
• Patients without symptoms of strangulated hernia will be included in the study.

You may not qualify if:

• Patients without consent
• Regional anesthesia is contraindicated,
• Those who will undergo open abdominal surgery,
• Not in the appropriate age range,
• Chronic diseases such as uncontrolled DM and HT,
• Drug allergy,
• Taking anticoagulant or antiaggregant drugs,
• History of chronic analgesic use,
• Presence of active infection in the area to be blocked,
• Will not be able to comply with postoperative pain /VAS follow-up,
• Patients with ASA-III-IV,
• Patients with bilateral inguinal and scrotal hernias,
• Patients who have been previously operated for inguinal hernia and have an incision in the lower abdomen,
• Those with a history of alcohol and drug abuse
• Preoperative pain and

Sponsors & Collaborators

• Başakşehir Çam & Sakura City Hospital: lead

Study Sites (1)

Başakşehir Çam ve Sakura Şehir Hastanesi

Başakşehir, Istanbul, 34480, Turkey (Türkiye)

RECRUITING

Related Publications (5)

• Mughal A, Khan A, Rehman J, Naseem H, Waldron R, Duggan M, Khan W, Barry K, Khan IZ. Laparoscopic-assisted transversus abdominis plane block as an effective analgesic in total extraperitoneal inguinal hernia repair: a double-blind, randomized controlled trial. Hernia. 2018 Oct;22(5):821-826. doi: 10.1007/s10029-018-1819-8. Epub 2018 Sep 1.

  PMID: 30173291 BACKGROUND

• Colak S, Akkus O, Gurbulak B, Cakar E, Bektas H. Infiltration of bupivacaine into the preperitoneal space and trocar incisions of patients undergoing laparoscopic totally extraperitoneal repair of unilateral inguinal hernia: a prospective randomized controlled observational study. Wideochir Inne Tech Maloinwazyjne. 2020 Mar;15(1):11-17. doi: 10.5114/wiitm.2019.84385. Epub 2019 Apr 11.

  PMID: 32117481 BACKGROUND

• Paasch C, Fiebelkorn J, De Santo G, Aljedani N, Ortiz P, Gauger U, Boettge K, Full SH, Anders S, Hunerbein M. Ultrasound-versus visual-guided transversus abdominis plane block prior to transabdominal preperitoneal ingunial hernia repair. A retrospective cohort study. Ann Med Surg (Lond). 2020 Sep 22;59:281-285. doi: 10.1016/j.amsu.2020.09.017. eCollection 2020 Nov.

  PMID: 33133582 BACKGROUND

• Grape S, Kirkham KR, Albrecht E. The analgesic efficacy of transversus abdominis plane block vs. wound infiltration after inguinal and infra-umbilical hernia repairs: A systematic review and meta-analysis with trial sequential analysis. Eur J Anaesthesiol. 2022 Jul 1;39(7):611-618. doi: 10.1097/EJA.0000000000001668. Epub 2022 Feb 7.

  PMID: 35131973 BACKGROUND

• Salmonsen CB, Lange KHW, Rothe C, Kleif J, Bertelsen CA. Cutaneous sensory block area of the laparoscopic-assisted transversus abdominis plane block. Dan Med J. 2024 Sep 9;71(10):A02240142. doi: 10.61409/A02240142.

  PMID: 39323259 BACKGROUND

Related Links

• The National Center for Biotechnology Information advances science and health by providing access to biomedical and genomic information.

MeSH Terms

Conditions

Bites and Stings; Hernia, Inguinal

Interventions

Dental Occlusion

Condition Hierarchy (Ancestors)

Poisoning; Chemically-Induced Disorders; Wounds and Injuries; Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dentistry; Dental Physiological Phenomena; Digestive System and Oral Physiological Phenomena

Study Officials

• EMINE OZCAN, MD

  Başakşehir Çam ve Sakura Şehir Hastanesi

  STUDY DIRECTOR

Central Study Contacts

Ali Bekraki, Principal Investigator

CONTACT

+905372437699; abekraki@hotmail.com

Yunus Fırat Emekli, Research Assistant

CONTACT

+905074920925; y.firatemekli@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Investigator

Model Details: Prospective Randomize

Study Record Dates

• First Submitted: March 19, 2025
• First Posted: March 25, 2025
• Study Start: September 4, 2025
• Primary Completion (Estimated): June 20, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: September 24, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: 01.01.2026- 01.-1.2027
• Access Criteria: The types of analyses that are appropriate for data sharing and the statistical methods for those analyses need to be approved by the independent reviewer.

Locations

TU (1)