Primary Inguinal Hernia
Conditions
Keywords
transverse abdominis plane block, inguinal hernia, TAPP technique, chronic postoperative pain, acute pain, inguinal hernia surgery
Brief summary
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.
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.
Interventions
PROCEDURETransversus abdominal plane block (TAP block)
Unilateral US-guided TAP-block lateral approach with 20 ml 0,375% Levobupivacaine before incision
Sponsors
Pirogov Russian National Research Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acute postoperative pain 4h | 4±1 hours postop | Pain score will be assessed using the Numeric Pain Rating Scale (NRS) (0-10) at rest and on coughing. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Acute postoperative pain 6h | 6±1 hours postop | Pain score will be assessed using the Numeric Pain Rating Scale (NRS) (0-10) at rest and on coughing. |
| Number of Participants meeting discharge criteria | 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) |
| Analgetic consumption (dose quantity) | 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. |
| Concentration of serum cortisol | At 8 am on the day of surgery, 4±1 hours postop | nmol/L |
| Acute postoperative pain 24h | 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. |
| Acute postoperative pain 2h | 2±1 hours postop | Pain score will be assessed using the Numeric Pain Rating Scale (NRS) (0-10) at rest and on coughing. |
| Number of Participants with postoperative complications | Postoperative 30 (±3) days | Number of Participants with postoperative complications, evaluated by Clavien-Dindo classification (telephone survey) |
| Patient satisfaction score | Postoperative 30 (±3) days | Patient satisfaction with treatment is assessed by telephone survey using the Linkert-type scale (1 - less satisfaction, 5 - more satisfaction) |
| Number of Participants with chronic pain | 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. |
| Number of Participants with recurrence | After 90 days | Participants undergo a telephone survey. Participants presenting with characteristic complaints are invited for examination and ultrasound scan. |
| Length of stay | From date of hospitalization until the date of discharge | Days |
Countries
Russia
Contacts
Primary ContactTaras Nechay, MD
Outcome results
None listed