The Effect of Preemptive Regional Anesthesia (TAP-block) on Acute and Chronic Pain After Transabdominal Preperitoneal Inguinal Hernia Repair (TAPP) (ERA-TAPP)

May 7, 2024 updated by: Taras V. Nechay, Pirogov Russian National Research Medical University

The Effect of Preemptive Regional Anesthesia (TAP-block) on Acute and Chronic Pain After Transabdominal Preperitoneal Inguinal Hernia Repair (TAPP) - a Randomized Controlled Trial

The study is devoted to the impact of preemptive regional Transversus abdominal plane block on the postoperative acute and chronic pain after elective Transabdominal preperitoneal (TAPP) inguinal hernia repair.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Inguinal hernia repair is one of the most common elective interventions in general surgery. Approximately 20 million inguinal hernia repairs are performed worldwide every year. Laparo-endoscopic techniques provide faster recovery times, lower chronic pain risk and are cost effective compared to open one.

Nevertheless, laparoscopic inguinal hernia repair can result in moderate to severe pain in the early postoperative period, interfering the time of returning to normal activity in a substantial quantity of patients. To reduce pain and to accelerate recovery, local and regional anesthetics has been successfully implemented into the daily routine of abdominal surgeries.

Recent systematic reviews have shown that TAP block can reduce analgetic consumption and acute pain scores after inguinal hernia repair. However, most included studies were conducted on patients with open hernia surgery or total extra peritoneal (TEP) inguinal hernia repair. Some studies showed the benefit of TAP block for early pain control following TAPP. Most of them were retrospective, some conducted with exclusion of obese or comorbid patients, some in mixed groups without separating patients with TAPP and TEP.

Thus, the evidence of TAP block efficiency prior to hernia repair in TAPP technique are of low quality.

Chronic postoperative inguinal pain (CPIP) develops in up to 6% of patients after TAPP. Several studies have found that intense acute postoperative pain is a risk factor for CPIP after IHR. The investigators hypothesize, that preemptive TAP block temporary stops nociception and central sensitization from the surgical site thus reduce acute postoperative pain that theoretically provoke reducing the incidence of CPIP following IHR. Two studies suggest that TAP block may influence the incidence of CPIP after TAPP. Considering the retrospective study design of both and the insufficient sample size further randomized clinical trials are mandatory to estimate this hypothesis.

The aim of our study is to explore the possibilities of reducing acute and chronic pain after TAPP via implementation TAP block.

The sample size was calculated based on the randomized controlled trial data of patients after TEP IHR where postoperative VAS score at 4 h on coughing was 4.7±1.5 in the preemptive local anesthesia group and 6.1±1.9 in the control group. A sample size of 39 patients was required for each subgroup (total=78 patients) with a type I error rate α=0.05 and type II error rate β=0.1.

Study Type

Interventional

Enrollment (Estimated)

78

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Russian Federation
      • Moscow, Russian Federation, 117997
        • Recruiting
        • Department of faculty surgery №1 Pirogov Russian National Research Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients with unilateral primary inguinal hernia who are scheduled for elective Transabdominal preperitoneal inguinal hernia repair (TAPP)
  • Signed Informed consent to participation
  • ASA I-III
  • BMI ≤35 kg/m2

Non-inclusion Criteria:

  • Inguinoscrotal hernia (hernia passing through the entrance to the scrotum)
  • Previously diagnosed mental disorders
  • Patients receiving psychotropic drugs and drugs affecting adrenal cortex function (estrogens and systemic glucocorticoids)
  • Language barrier

Exclusion Criteria:

  • Deviations during the operation/anesthesia that required transfer to the intensive care unit or conversion to open surgery
  • Refusal to participate

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TAP-block
TAPP inguinal hernia repair under general anesthesia with endotracheal intubation. Patients receive unilateral US-guided TAP-block with 20 ml 0,375% Levobupivacaine before incision
Procedure: Transversus abdominal plane block (TAP block)
Unilateral US-guided TAP-block lateral approach with 20 ml 0,375% Levobupivacaine before incision
No Intervention: Standard care
TAPP inguinal hernia repair under general anesthesia with endotracheal intubation (without preemptive regional anesthesia) in accordance with actual standard of care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acute postoperative pain 4h
Time Frame: 4±1 hours postop
Pain score will be assessed using the Numeric Pain Rating Scale (NRS) (0-10) at rest and on coughing.
4±1 hours postop

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acute postoperative pain 2h
Time Frame: 2±1 hours postop
Pain score will be assessed using the Numeric Pain Rating Scale (NRS) (0-10) at rest and on coughing.
2±1 hours postop
Acute postoperative pain 6h
Time Frame: 6±1 hours postop
Pain score will be assessed using the Numeric Pain Rating Scale (NRS) (0-10) at rest and on coughing.
6±1 hours postop
Number of Participants meeting discharge criteria
Time Frame: 6±1 hours postop
Blood pressure ≥100/60 mm Hg; Activation within the department; Ability to oral medication (no postoperative nausea and vomiting); Pain (NRS) ≤3 points; No signs of complications (bleeding, early relapse)
6±1 hours postop
Analgetic consumption (dose quantity)
Time Frame: 24 hours postop
At NRS score 4-6 at rest patients receive: 30mg Ketorolak IV no more than once every 8 hours or 1000mg Acetaminophen IV no more than once every 6 hours; At NRS score ≥7 at rest patients receive 100 mg Tramadol IV no more than once every 12 hours; The number of analgesic doses administered is counted.
24 hours postop
Concentration of serum cortisol
Time Frame: At 8 am on the day of surgery, 4±1 hours postop
nmol/L
At 8 am on the day of surgery, 4±1 hours postop
Acute postoperative pain 24h
Time Frame: 24±3 hours postop

Pain score will be assessed using the Numeric Pain Rating Scale (NRS) (0-10) at rest and on coughing.

Participants verbally requested to rate their pain: "Rate your pain from 0 (no pain) to 10 (unbearable pain)". 0 point is the minimum and 10 point is the maximum. The higher the score, the more severe the pain.
24±3 hours postop
Length of stay
Time Frame: From date of hospitalization until the date of discharge
Days
From date of hospitalization until the date of discharge
Number of Participants with postoperative complications
Time Frame: Postoperative 30 (±3) days
Number of Participants with postoperative complications, evaluated by Clavien-Dindo classification (telephone survey)
Postoperative 30 (±3) days
Patient satisfaction score
Time Frame: Postoperative 30 (±3) days
Patient satisfaction with treatment is assessed by telephone survey using the Linkert-type scale (1 - less satisfaction, 5 - more satisfaction)
Postoperative 30 (±3) days
Number of Participants with chronic pain
Time Frame: Postoperative 90 (±3) days
Pain score will be assessed by NRS (telephone survey). Participants verbally requested to rate their pain: "Rate your pain from 0 (no pain) to 10 (unbearable pain)". 0 point is the minimum and 10 point is the maximum. The higher the score, the more severe the pain.
Postoperative 90 (±3) days
Number of Participants with recurrence
Time Frame: After 90 days
Participants undergo a telephone survey. Participants presenting with characteristic complaints are invited for examination and ultrasound scan.
After 90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pirogov Russian National Research Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2024

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

March 31, 2025

Study Registration Dates

First Submitted

April 20, 2024

First Submitted That Met QC Criteria

May 7, 2024

First Posted (Actual)

May 9, 2024

Study Record Updates

Last Update Posted (Actual)

May 9, 2024

Last Update Submitted That Met QC Criteria

May 7, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2 (Other Identifier: Instituto Cardiovascular de Buenos Aires)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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