A study to analyse the effect of spraying a pain-reducing medication in patients undergoing laparoscopic inguinal hernia surgery into a space in the abdomen during surgery and analysis of pain relief after surgery.

Aerosolized Ropivacaine Installation in the Preperitoneal Space for Postoperative Analgesia after Extended Totally Extra Peritoneal Inguinal Hernia Repair: A Double-blinded Randomized control Trial - ARISe-TEP trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/03/106256

Enrollment

Registered

2026-03-16

Start date

Unknown

Completion date

Unknown

Last updated

2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: O- Medical and Surgical Health Condition 2: K402- Bilateral inguinal hernia, withoutobstruction or gangrene Health Condition 3: K409- Unilateral inguinal hernia, without obstruction or gangrene

Interventions

Intervention1: Ropivacaine nebulization: After confirming the optimal position of mesh the extraperitoneal space will be instilled with ropivacaine 0.75 percentage 2-3 mg/kg with a maximum of 20 mL (1

Eligibility

Inclusion criteria

Inclusion criteria: 1. Adults aged 18 75 years. 2. Elective, primary, unilateral, uncomplicated, inguinal hernia scheduled for laparoscopic eTEP repair under general anaesthesia. 3. Capable of giving informed consent and cooperating with pain scoring.

Exclusion criteria

Exclusion criteria: 1. Allergy to amide local anaesthetics. 2. Chronic opioid use (daily opioid use more than 2 weeks prior). 3. Significant hepatic impairment (affecting Ropivacaine metabolism) 4. Coagulopathy or on anticoagulants that cannot be stopped per institutional policy. 5. Pregnant or breastfeeding women. 6. Previous lower abdominal surgeries.

Design outcomes

Primary

Measure	Time frame
Post-operative pain measured by visual analog scale (VAS 0-10)Timepoint: Postoperative pain measured by VAS score every two hourly for first six hours followed by every sixth hourly for 48 hours and on POD 7 (If patient stays in hospital or at the time of follow-up visit for suture removal) and after one and three months (follow-up visit)	—

Secondary

Measure	Time frame
Total opioid consumptionTimepoint: During the first 48 hours post-operatively;Time to first analgesic requestTimepoint: Recorded post-operatively until first analgesia requested;Length of hospital stayTimepoint: Until discharge;Postoperative complicationsTimepoint: SSI, hematoma, seroma, urinary retention During hospital stay and within 30 days post-op;Chronic groin painTimepoint: 3 months after surgery;Quality of life by HerQLes questionnaireTimepoint: 3 months after surgery	—

Measure

Time frame

Total opioid consumptionTimepoint: During the first 48 hours post-operatively;Time to first analgesic requestTimepoint: Recorded post-operatively until first analgesia requested;Length of hospital stayTimepoint: Until discharge;Postoperative complicationsTimepoint: SSI, hematoma, seroma, urinary retention During hospital stay and within 30 days post-op;Chronic groin painTimepoint: 3 months after surgery;Quality of life by HerQLes questionnaireTimepoint: 3 months after surgery

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Countries

India

Contacts

Public ContactRUBAN RICHARD P

Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry

k26uday74@yahoo.co.in9940306513

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Apr 4, 2026