AIM:

The primary aim of this research is to compare the efficacy of Transdermal Ketoprofen patch of 30mg versus Transdermal Fentanyl patch of 25mcg in respect to post-operative analgesia, duration of analgesia, patient comfort and satisfaction.

PRIMARY OBJECTIVE:

 To compare the efficacy of Transdermal Ketoprofen  patch 30mg versus Transdermal Fentanyl patch 25mcg for post-operative analgesia in women undergoing Lower Segmental Caesarean Section.

SECONDARY OBJECTIVE:

1)    Patient comfort

2)    Side effects

     INCLUSION CRITERIA:

      Ages between 18-40 years scheduled for elective and emergency caesarean sections.

2)    ASA grade I and II fit parturient women.

3)    Body mass index (BMI) between 20-25kg/m2.

4)    Acceptance of study and signing informed consent.

EXCLUSION CRITERIA 

1)    Denial to consent for the study

2)    History of NSAIDs allergy and opioid sensitivity.

3)    History of opioid abuse.

4)    Active peptic ulcer disease within 6 months

5)    Major systemic illness like Bronchial Asthma, Epilepsy, COPD, Liver disease, Cardiac disease, Renal disease and Coagulopathy.

6)    Contraindications to spinal anaesthesia.

     METHODOLOGY:

For all pregnant women in inclusion criteria scheduled for lower segment caesarean sections (LSCS) pre-anesthesia checkup will be done and assessed before surgery. Spinal anaesthesia technique and its complications will be explained before taking consent. An 18G wide bore cannula will be secured to all parturient women. Baseline vitals are recorded in preop using ASA standard monitors. 500 mL of Ringer Lactate as preload, Inj. Pantaprazole 40mg and Inj. Ondansetron 4mg will be given intravenously as premedications.

In the operating room, all standard monitors according to ASA (NIBP, ECG, pulse oximeter) will be connected and values recorded. Parturient will be made to sit with hips flexed and knees extended in the operating table. Under all aseptic precautions, scrubbing with 10% Povidone-iodine done and draped with sterile towel. After palpation of appropriate anatomical landmark (L2-L3 or L3-L4), 2ml of Inj. Lignocaine 2% will be given as local skin infiltration. 26G Quinky’s spinal needle will be introduced in the sub arachnoid space and after confirmation of free flow of cerebrospinal fluid, 2.2ml of 0.5% Inj. Bupivacaine heavy will be injected intrathecally at the rate of 0.2ml/second. Group A parturient will be receiving Transdermal Ketoprofen 30mg patch on hair-free area in the antero-lateral chest wall or upper or at the sides of the waist and mounted in place and covered by adhesive plasters immediately after spinal anaesthesia and  Group B parturient will be receiving Transdermal Fentanyl 25mcg/hr patch on same sites immediately after spinal anaesthesia. Parturient will be made to lie down immediately and the level of block will be assessed using Bromage scale. After an adequate blockade (T6) surgery will be started. NIBP is measured every 3^rd minute and intraoperative hypotension is defined as decrease in systolic blood pressure of less than 20% of the baseline value recorded and treated with Inj. Ephedrine 6mg or Inj. Phenylepherine 50-100mg intravenously along with bolus fluids. Bradycardia is defined as heart rate less than less than 50 beats/min and treated according to symptoms appropriately. Immediately after delivery of baby, 10 IU of Inj.Oxytocin will be given along with fluids. Parturient will be monitored and other complications like Nausea, Vomiting, Shivering and patch site irritation will be treated. Once the surgery is completed vitals and level of spinal anaesthesia will be checked and patient will be shifted to Post Anaesthesia Care Unit (PACU). In the PACU all monitors according to ASA will be attached and parameters will be monitored.

Pain assessment, patients comfort and any side effects (nausea, vomiting, erythema, pruritus, sedation, respiratory depression) will be monitored post-operatively. Pain assessment will be done by Visual Analogue Scale (VAS) every 2^nd hourly. Patient will be asked to rate their level of pain. A VAS score of 4 and above will be treated with Inj. Tramadol 100mg or Inj. Paracetamol 1g and its frequency will be noted. Sedation score will be measured using Ramsay sedation score (RSS) to all the patients.