An interventional study of Transversus abdominal plane block (TAP block) in Primary Inguinal Hernia, sponsored by Pirogov Russian National Research Medical University. Recruiting at 1 site in Russian Federation. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-05-09.
Sponsored by Pirogov Russian National Research Medical University · Not applicable, Interventional, and Prevention
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.
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.
2,930 studies on the registry are indexed under Chronic Pain; 699 are open to participants now.
This study's planned enrollment of 78 is above the median of 60 across 2,160 interventional studies indexed under Chronic Pain.
Browse Chronic Pain studies →Pirogov Russian National Research Medical University is the lead sponsor of 54 studies on the registry; 15 are open to participants now.
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Non-inclusion Criteria:
Exclusion Criteria:
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)
TAPP inguinal hernia repair under general anesthesia with endotracheal intubation (without preemptive regional anesthesia) in accordance with actual standard of care.
Unilateral US-guided TAP-block lateral approach with 20 ml 0,375% Levobupivacaine before incision
Acute postoperative pain 4h
Pain score will be assessed using the Numeric Pain Rating Scale (NRS) (0-10) at rest and on coughing.
Time frame: 4±1 hours postop
Acute postoperative pain 2h
Pain score will be assessed using the Numeric Pain Rating Scale (NRS) (0-10) at rest and on coughing.
Time frame: 2±1 hours postop
Acute postoperative pain 6h
Pain score will be assessed using the Numeric Pain Rating Scale (NRS) (0-10) at rest and on coughing.
Time frame: 6±1 hours postop
Number of Participants meeting discharge criteria
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)
Time frame: 6±1 hours postop
Analgetic consumption (dose quantity)
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.
Time frame: 24 hours postop
Concentration of serum cortisol
nmol/L
Time frame: At 8 am on the day of surgery, 4±1 hours postop
Acute postoperative pain 24h
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.
Time frame: 24±3 hours postop
Length of stay
Days
Time frame: From date of hospitalization until the date of discharge
Number of Participants with postoperative complications
Number of Participants with postoperative complications, evaluated by Clavien-Dindo classification (telephone survey)
Time frame: Postoperative 30 (±3) days
Patient satisfaction score
Patient satisfaction with treatment is assessed by telephone survey using the Linkert-type scale (1 - less satisfaction, 5 - more satisfaction)
Time frame: Postoperative 30 (±3) days
Number of Participants with chronic pain
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.
Time frame: Postoperative 90 (±3) days
Number of Participants with recurrence
Participants undergo a telephone survey. Participants presenting with characteristic complaints are invited for examination and ultrasound scan.
Time frame: After 90 days
Plan to share: No
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Pirogov Russian National Research Medical University