Efficacy of preoperative use of oral pregabalin versus gabapentin in multi modal analgesia for postoperative pain relief after total abdominal hysterectomy under spinal anesthesia A Randomized controlled study

AIM

Comparison of efficacy of pregabalin versus gabapentin as a part of multi modal analgesia for post- operative pain relief after total abdominal hysterectomy under spinal anaesthesia.

OBJECTIVES:

PRIMARY OBJECTIVE:

Comparison of pregabalin and gabapentin as a part of multimodal analgesia for post- operative pain relief and total duration of analgesia.

SECONDARY OBJECTIVES:

Hemodynamic stability

Compare adverse effect and complications

METHODOLOGY:

Ethical consideration- The study will be conducted following the principles of Helsinki declaration. This study will be conducted after getting approval from local ethical committee of GMERS Medical College and Hospital, Gotri, Vadodara. It will be registered with clinical trial registry of India. Written and Informed consent will be taken from all participants. Data collected will be kept confidential.

Study design-Randomized controlled study, Double blind, Parallel group

Study setting- Tertiary care teaching hospital (GMERS Medical college and Hospital), Gotri, Vadodara.

Study duration- Approx. 6 months,  Study population- Patients posted for Total Abdominal Hysterectomy

INCLUSION CRITERIA:

1. Age- 35 to 65 years of age

2. American society of anaesthesia grading: I or II

3. Body Mass Index:- <35 kg/m2

EXCLUSION CRITERIA:

1. Patient with absolute & relative contraindications of spinal anaesthesia

2. Hypersensitivity to study drugs

3. Impaired renal functions

4. Patients with psychiatric disorders

5. Alcoholic patients

6. Patient’s refusal to take part in study

7. Duration of surgery > 2 hours

8. Patient already on Tab. Pregabalin/ Gabapentin

Study procedure:

Randomization and allocation: Patients will be randomly divided into two groups by simple randomization with 1:1 uniform allocation. Randomization and allocation will be conducted by person, not involved in the study. The sequential random numbers assigned to study participants will be kept in sealed opaque envelops, to be opened after recruitment of the participants in the study, just before giving the allocated Drug.

The groups are as follows:

Group P:- Patient who will receive Tab. Pregabalin 300 mg

Group G:- Patient who will receive Tab. Gabapentin 1200 mg

INTERVENTION: History will be taken regarding present and past complains, personal history, medication history, history of previous anaesthesia exposure, blood transfusions etc. General and systemic examination will be done. Routine and specific investigations will be carried out as and when indicated.

Tab. Pregabalin 300 mg or Tab. Gabapentin 1200 mg orally given 1 hour before surgery. . Pre operative vitals are recorded ( Pulse, blood pressure, Respiratory rate, Spo2). After securing intra venous line, intravenous fluid (Inj. RL) will be started

SPINAL ANESTHESIA TECHNIQUE: Under all aseptic & antiseptic precautions spinal anaesthesia will be given. In this method, Inj. Levo bupivacaine (Heavy) (0.5%) 3.0 ml + Inj. Fentanyl 25 mcg(0.5ml) ]given. Desirable level of sub arachnoid block upto T6.

At the end of surgery, Inj. Paracetamol 1 gm iv. given.

Duration of effective analgesia will be measured as time from intrathecal drug administration to patient’s 1st request for analgesic.  Visual analog Scale (VAS ≥ 4).

Pain Scoring:- Visual Analog Scale (VAS)

Score

Criteria

|Score 0

No Pain

|Score 1,2,3

Mild Pain

|Score 4,5,6

Moderate Pain

|Score 7.8,9

Worst imaginable Pain

 The efficacy end point is defined as request of rescue analgesic medication by patient.

Inj. Tramadol 100 mg iv stat will be given as a rescue medication, if patient complains of Pain (VAS ≥ 4).

OUTCOME MEASURES:

Primary outcome-

Comparison of pregabalin and gabapentin for post- operative pain relief and total duration of analgesia.

Secondary outcome-

Comparison of hemodynamic stability

Look for any adverse effects like sedation (by Ramsay Sedation Score)