Comparative study of effectiveness of intrathecal hyperbaric ropivacaine and hyperbaric levobupivacaine in combination with fentanyl in patients undergoing brachytherapy for gynecological malignancy

Brief Description Of The Intended Work

TITLE - Comparative study of effectiveness of intrathecal hyperbaric ropivacaine and hyperbaric levobupivacaine in combination with fentanyl in patients undergoing brachytherapy for gynecological malignancy.

Brachytherapy is a procedure used for treatment of certain cancers which involves the placement of radioactive substances in or near a tumour. The procedure of insertion of radioactive implants for gynecological malignancy is extremely painful, so the patient needs to be immobile and requires optimal analgesia. Spinal anaesthesia is commonly administered for these procedures.

Bupivacaine is widely used for spinal anaesthesia because of its long duration of action and its motor and sensory blockade. Newer analogues like levobupivacaine which is less cardiotoxic and ropivacaine which causes lesser motor blockade have been introduced into clinical practice. A few studies have shown in the efficacy of hyperbaric levobupivacaine and hyperbaric ropivacaine in gynecological, lower abdominal, urological and lower limb surgeries.

However there are no studies comparing these drugs in patients undergoing brachytherapy, hence this study is being conducted to compare the efficacy of intrathecal hyperbaric ropivacaine and hyperbaric levobupivacaine in combination with fentanyl in patients undergoing brachytherapy for gynecological malignancy.

 Primary objective:

To study the duration of sensory and motor blockade in both levobupivacaine and ropivacaine group and time for two segment regression of sensory level.

Secondary objective:  To study

a)     Onset of sensory block.

b)     Onset of motor block.

c)     Highest level of sensory block

d)     Side effects

Materials and methods

Source Of Data: St Johns National Academy Of Health Sciences, Bengaluru

Study Period: 2 Years

Study Design: Randomized Controlled Trial

Sample Size:  25 Per Group

 a) SUBJECTS

Inclusion criteria

•          Patients aged between 20-70 years

•          Scheduled for brachytherapy in gynecological malignancy

Exclusion criteria

•          Patient with allergy to local anaesthetics.

•          Patients with severe hepatic, cardiac and renal dysfunction.

•          Obese patients, BMI

35.

•          Patients with spinal abnormalities.

The prospective, randomized, double blind study will be conducted after obtaining approval from Institutional Ethical Committee (IEC) and written informed consent 50 patients between the age of 20-70 scheduled for brachytherapy for gynaecological malignancy will be recruited for the study.

Group L(n=25)- This group will receive 1.8ml of 0.5% hyperbaric Levobupivacaine+ 25 mcg of fentanyl intrathecally.

Group R(n=25)- This group will receive 1.8ml of 0.75% hyperbaric ropivacaine+ 25 mcg of fentanyl intrathecally.

Hemodynamics- HR, SBP, DBP. MAP, SPO2 will be recorded.

The following parameters will be noted,

•          Duration of sensory block (time period from onset of block to the time of regression to S2)

•          Duration of motor blockade (time period from onset to Bromage scale 3 to 0.

•          Time of onset of sensory block (time from intrathecal injection to time to achieve T10 segment level block)

•          Time of onset of motor block (Time from injection of study drug to the time to achieve Bromage scale 3 i.e., patient is unable to move the hip, knee and ankle joint).

•          Time to highest level of sensory blockade.

•          Time for two segment regression of sensory level (time taken for regression of the block to two dermatomal segments after injecting the drug).