The present study will be conducted in the Department
of Anaesthesiology, Himalayan Institute of Medical Sciences, Swami Ram
Nagar, Dehradun over a period of 12 months after obtaining an informed written
consent from the patients and ethical clearance from the institutional ethics
committee. Patients undergoing Total Abdominal Hysterectomy under general
anaesthesia in the Obstetrics and Gynaecology department at Himalayan Institute
of Medical Sciences, Swami Ram Nagar, Dehradun will be included in the study.
Sample Size: In
Uttarakhand, the proportion of women who had hysterectomy is 2.1% based on the
data of NFHS-4 (16). Sample size is calculated using the formula
n = Z2(1- α /2) P(1-P)
L2
where,
n = required sample size
z= 1.96 at 0.05 level of significance
p=proportion of hysterectomy which has been taken as
0.021
L= 5% of absolute precision
n=1.96x1.96x0.021x0.98/(0.05)2
n=32 in each group
32 patients each will be included in 3 groups and
hence total 96 patients will be included in the study.
All selected patients will undergo routine pre
anaesthetic checkup which includes complete history, physical examination and
routine laboratory investigations.
â— Patients
will be divided into 3 groups (32 patients each)
1. Group A (Control
group): 40ml 0.25% Ropivacaine(20ml on each side) in Normal Saline (in 1:1
ratio)
2. Group B: 40ml 0.25%
Ropivacaine(20ml on each side)+ Dexmedetomidine 0.75μg/kg
3. Group C: 40ml 0.25%
Ropivacaine(20ml on each side)+ low-molecular weight dextran in (1:1 ratio)
Upon completion of surgery,
Erector spinae plane block will be performed under USG
guidance using a high frequency linear probe/transducer in lateral position.
The transducer will be placed in a parasagittal orientation 3cm lateral to T9
spinous process.
â— Patient
Controlled analgesia (PCA) pump with morphine will be used as analgesic
supplement so that patient can herself administer morphine when required. PCA
pump will be started with concentration of 1mg/ml of morphine, demand dose of
morphine through PCA pump will be 1.5 ml with lockout interval of 15
minutes, maximum limit in 4 hrs will be 20 mg. Along with it, paracetamol 1 gm
i.v. will be given every 8 hourly.
â— The time
duration of the first rescue analgesic request from the time patient was
shifted to PACU, PCA pump press number, number of times drug is delivered
and total morphine consumption in 24 h postoperatively will be recorded in all
three groups. However if pain persists even after administration of
morphine and PCM, diclofenac 75 mg i.v. will be used as a rescue analgesic.
QoR 40 questionnaire will be used postoperatively to
measure the quality of recovery after anaesthesia on the third
post-operative day .
â— Adverse
effects if any will be noted, including nausea and/or vomiting and if present
treated with ondansetron 0.1 mg/kg i.v.Hypotension (mean arterial pressure
<20% of baseline or <60 mmHg) treated with an infusion of normal saline
and if necessary an i.v. injection of ephedrine 5–10 mg incremental doses will
be administrated. Bradycardia (heart rate <60 beats/min) will be treated
with i.v atropine 0.01mg/kg bolus.
â— In
statistical analysis the primary outcome will be the total amount of opioid
consumption in first 24 hours
â— The
secondary outcome variable will be:
1. Time of first rescue
analgesic request( time from PACU shifting to first requested rescue analgesic)
2. Total amount of
prescribed analgesic in PACU
3. Any opioid related
side effects like respiratory depression, pruritis within the first 24 hours.
|