Efficacy and safety of tramadol versus buprenorphine administrated epidurally for postoperative pain relief - a prospective comparative study

Efficacy and safety of tramadol versus buprenorphine administered epidurally for postoperative pain relief- a prospective randomized comparative study

METHODOLOGY:

During pre-anesthetic assessment, detailed history will be collected and the clinical

examination will be done. Relevant investigations will be obtained for each patient. The patients will

be explained about the epidural technique with catheter in situ. Patients will be explained about usage

of linear visual analogue scale for assessment of the intensity of pain. A written informed consent will

be obtained from each patient. All the patients will be kept in nil by mouth as per ASA guidelines,

prior to the surgery. All patients will be randomized into two groups, (Group T Tramadol group (n=25)

and Group B Buprenorphine group(n=25)) by lots.

All the patients in both the groups will be premedicated with Tab. Alprazolam 0.25mg per oral,

night before the scheduled day of surgery. An appropriately sized cannula will be used to secure

intravenous access. On the day of surgery, in operating room, pulse oximeter, electrocardiogram, and

non-invasive blood pressure will be connected to the patient and the baseline values will be recorded.

All the emergency drugs and airway equipment’s will be kept ready. After positioning the patient in

sitting position, under strict aseptic precautions, 18 G Tuohy epidural needle will be introduced at L1-

L2 or L2- L3 interspace and space will be confirmed using loss of resistance technique. Epidural

catheter will be inserted and fixed at the skin level as such 5cm of the catheter stays in the epidural

space. A test dose of 3ml of 2% lignocaine with adrenaline will be given to ensure that epidural catheter

is not intravascular or intrathecal.

Following epidural catheter placement, all patients will be given spinal anesthesia for the

surgical procedure one interspace below epidural puncture site using 23G or 25G Quincke spinal

needle and appropriate dose of 0.5% bupivacaine heavy will be given. Sensory and motor block levels

will be assessed

Sensory block will be assessed using pinprick test to determine the level of dermatome

blocked.

Motor block will be assessed by the Bromage scale.

Intraoperative epidural top up will be activated with local anesthetic once spinal effect

regresses two levels below the initial level.

At the end of surgery, patients will be shifted to recovery room. Upon arrival to recovery room,

pulse rate, respiratory rate, peripheral oxygen saturation, blood pressure, pain score will be assessed

and recorded.

Epidural dose of opioid will be given according to group allotted, when the patient complaints

of pain (VAS score >3)

Group T (tramadol group) will receive single dose 1mg per kg of tramadol in 10ml of normal

saline and group B (buprenorphine group) will receive single dose of 2 mcg per kg of buprenorphine

in 10ml of normal saline, via epidural catheter.

Following the first epidural opioid dose, patients will be assessed for pain intensity (VAS score)  onset,

duration of analgesia, hemodynamic parameters ( heart rate, systolic blood pressure, diastolic blood pressure, percentage saturation of oxygen,  respiratory rate) , adverse effects such as nausea, vomiting,  pruritus,  urinary retention at intervals of 0 mins, 30 mins,

1st hour, 1hour 30mins, 2nd hour, 3rd hour, 4th hour, 5th hour, 6th hour, 12th hour and 24th hour.

Duration of analgesia is assessed from the administration of first dose of drug till requirement of second dose of drug. Then study is abandoned