To Compare different concentrations of Ropivacaine for post operative pain relief in inguinal hernia repair
- Conditions
- Unilateral inguinal hernia, without obstruction or gangrene,
- Registration Number
- CTRI/2019/03/017888
- Lead Sponsor
- Department of Anaesthesia Teerthanker Mahaveer Hospital
- Brief Summary
To Compare two different concentrations of Ropivacaine 0.25% and 0.5% for post operative analgesia in inguinal hernia repair.
Randomisation will be performed using chit and box method and the patients will be divided into two groups.
**Group A**- 20ml of **0.25%**Ropivacaine subcutaneously,
**Group B**- 20ml of **0.5%**Ropivacaine subcutaneously
**SKIN INFILTRATION**: Study drug of 20ml Ropivacaine will be administered subcutaneously at the time of skin closure on both sides of incision by double blind technique.
• After the surgery, the patients will be shifted to the recovery room and standard monitoring like ECG, NIBP, SpO2 will be attached **.**
• Patients will be observed in the recovery room for 60min and will be assessed every 15 min. Postoperative Hemodynamic parameters- H.R, SPO2, SBP,DBP,MAP will be noted.
• Postoperatively, the pain on rest, pain on coughing and pain on movements will be assessed using VAS score immediately after the surgery and then every 2 hours to 12 hours.
• The time of first request for rescue analgesia will be noted and rescue analgesia will be provided with Inj.Tramadol 1mg/kg iv on demand or when VAS score more than 4. Total dose of rescue analgesia given in 12 hours will be recorded.
• Side effects such as headache, nausea, vomiting, allergic reactions and convulsions will be looked for.
This prospective randomized clinical study compared Ropivacaine 0.25% and 0.5% for post-operative analgesia for the repair of inguinal hernia. There was an almost uniform distribution of the males and females among 2 groups. The mean age of the subjects in the 2 groups was 43.44±10.74 years and 41.63±11.55 years respectively.
No significant difference in heart rate, Systolic blood pressure, Diastolic blood pressure, Mean blood pressure and SpO2 between 2 groups. The mean VAS score (at Rest) at 8 hours was significantly more among GROUP A (0.50%) compared to GROUP B (0.25%). The mean VAS score (at Coughing) at 6, 8 and 10 hours was significantly more among GROUP B (0.25%) compared to GROUP A (0.50%). The mean VAS score (at movement) at 8, 10 and 12 hours was significantly more among GROUP B (0.25%) compared to GROUP A (0.50%).
Inguinal hernia surgery can be well undertaken in local infiltration technique. The field block technique meets all the requirements needed for the surgery, like adequate analgesia, enough relaxation, good haemodynamic stability, minimal side effects and in addition longer post-operative pain relief. It is the well suited technique for day care surgery. Ropivacaine 0.5% provided good quality anesthesia for inguinal surgery compared to 0.25% Ropivacaine.
Ropivacaine as an anesthetic in inguiÂnal hernia repair for elderly patients is safe and effective in pain reduction, with very few adverse reactions. Ropivacaine is optimally effective regarding heart rate reduction, arterial pressure, or perceived pain by patients at the concentration of 0.5% with least side effects.
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2. Suman LG, Prasanna B. Postoperative analgesia after inguinal hernia repair comparing bupivacaine with Ropivacaine. Anaesthesia essays and researches. 2016;10:71-6.
3. Parekh SB, Parikh SS, Patel H, Mehta M. A prospective comparative observational study of clinical efficacy of isobaric ropivacaine 0.75% with of isobaric bupivacaine 0.5% intrathecally in elective inguinal hernia repair surgeries. Anesth Essays Res 2017;11:561-6.
4. Zavadinack Netto M, Prado Filho OR, Bandeira COP, Sales KPF, Camiloti TA. Herniorrafia inguinal: anestesia local ou regional? Acta Scientiarum 22(2);621-623, 2000.
5. Ribeiro FAS. Cirurgia Ambulatorial. In: Saad Junior R, Salles ROR, Carvalho WR, Maia AM, editores. Tratado de Cirurgia do CBC. São Paulo: Atheneu; 2009. p.1467-81.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 96
- American Society of Anaesthesiologists (ASA) grade I & II patients 2. Patients with BMI 18.5-22.9 kg/m2 3. 18.
- Patients refusal 2.
- Hypersensitivity to local anesthetics 3.
- BMI > 25 kg/m2 4.
- Chronic analgesic therapy 5.
- Giant inguinoscrotal hernias 6.
- Any absolute contraindications to spinal anaesthesia •Hernia with hydrocele •Any surgery extending more than 100 minutes.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Duration of postoperative analgesia for two different concentrations of Ropivacaine. 18 months
- Secondary Outcome Measures
Name Time Method Hemodynamic Parameters and side effects 18 months
Trial Locations
- Locations (1)
Teerthanker Mahaveer Medical college and research centre
🇮🇳Moradabad, UTTAR PRADESH, India
Teerthanker Mahaveer Medical college and research centre🇮🇳Moradabad, UTTAR PRADESH, IndiaDr M Niranjan ReddyPrincipal investigator8522838456tillureddy1@gmail.com