Comparative study of intravenous Diclofenac versus intravenous Ibuprofen injection as pre-emptive analgesia in patient posted for minor Perianal surgery under saddle block

AIM OF STUDY-

Comparison of efficacy of Intravenous diclofenac versus intravenous ibuprofen as pre-emptive analgesia in minor perianal and perineum surgery.

 OBJECTIVES-

 PRIMARY OBJECTIVE -

Comparing the duration of analgesia of Intravenous diclofenac versus intravenous ibuprofen as pre-emptive analgesia.

 SECONDARY OBJECTIVE -

·      Total Consumption of Rescue Analgesia within 24 hours

·      Noting any side effects

METHODOLOGY

 ETHICAL CONSIDERATION-This Study will be Conducted after obtaining Ethical Approval by Local Ethical committee of GMERS Medical College and Hospital, Gotri, Vadodara and topic registered with CTRI.

 STUDY DESIGN- Prospective Randomised Controlled, single Blind clinical study with allocation concealment and a uniform allocation sequence.

 STUDY PLACE- General Surgery operating unit in a tertiary Care teaching Hospital (GMERS Medical College and Hospital, Vadodara)

 STUDY PERIOD- over the period 6 months after the approval from Ethical Committee.

 STUDY POPULATION- Patients undergoing elective Hemorrhoidectomy under Saddle block.

INCLUSION CRITERIA

·      Age between 18-60 years

·      ASA Grading 1 and 2

·      Both Sexes

·      Surgery duration less than 60 minutes

 EXCLUSION CRITERIA

·      Patient’s Refusal

·      Patient who are contraindicated for saddle block

·      Allergic to study drugs.

·      Altered renal function (serum creatinine >1.4 mg/dl) and reactive airway diseases.

   STUDY PROCEDURE

  RANDOMISATION

After considering inclusion/exclusion criteria, the patients will be randomly distributed into two equal groups by using computer generated random sequence.

 Group D- Intravenous diclofenac 75 mg diluted in 100 ml NS over 15 mins

Group I- Intravenous Ibuprofen 400 mg infusion over 15 mins

INTERVENTION-

 ·   Thorough Pre-operative assessment will be carried out for each patient prior to the surgery. On the day of surgery, after confirming NPO status for 6 hours and noting baseline vital Parameters.

·   30 minutes before induction in the preoperative room,

Group D- Patient will receive Intravenous Diclofenac 75 mg in 100 ml NS over 15 mins period

Group I-Patient will receive intravenous Ibuprofen 400 mg infusion over 15 minutes

 · After premedication with Injection Ondansetron 0.08mg/kg Intravenous, under aseptic conditions, the saddle block will be performed by anaesthesiologist, using a standard midline approach in the sitting

position at the level of L3–L4 intervertebral space, with a 25-G Quincke needle with the bevel directed caudally and 5mg (1.0 mL) of hyperbaric bupivacaine 0.5% will be injected.

· After making patient sit for six minutes sensory blockade will be checked by Pin-prick sensation over the perineal area.

· The motor block will be tested with the “Modified Bromage Scale”

0-no motor block,

1-able to flex the ankle and bend knees,

2-able to flex ankle,

3-full motor block

 A successful block will be defined as one that is sufficient to proceed with the surgery without any supplementation (intravenous   analgesic, local anesthetic infiltration, or general anaesthesia) and that    particular patient will be taken as a study case.

   Qualitative pain - Visual Analogue Scale (VAS)-

Patients will be explained about Visual Analogue Scale (VAS)scoring system and asked to mark a vertical mark on the following scale which reflected the intensity of pain, they experienced at that time. Postoperative VAS score will be noted at 0,2,4,6,8 hour after surgery. The duration of analgesia will be noted in both groups and rescue analgesia injection tramadol 2mg/kg will be given when VAS score is >4.

  0 -no pain

1 to 2-least pain

3 to 4-mild pain

5 to 6-moderate pain

7 to 8-severe pain

9 to 10-excruciating pain

   OUTCOME MEASURES

 Primary outcome-Postoperative VAS score at 0,2,4,6,8 hour after surgery and duration of analgesia in both study groups

 Secondary Outcome- Time required for first rescue analgesia and Total consumption of Rescue analgesia in 24 hours.