Comparision of morphine in two different doses as adjuvant to hyperbaric ropivacaine versus plain hyperbaric ropivacaine in lower limb surgeries.

Phase 3

Not yet recruiting

Conditions: Disorder of continuity of bone, unspecified, (2) ICD-10 Condition: O||Medical and Surgical,

Brief Summary: Post operative pain after major orthopedic surgeries can be controlled by intrathecal administration of opioids and local anaesthetics. Effective intrathecal analgesia achieved through synergism between local anaesthetics and opioids is a well established phenomenon1. In some of the studies, it is stated that addition of opioids like morphine or fentanyl to local anaesthetic like bupivacaine or ropivacaine may improve the quality of analgesia. As ropivacaine poses the natural vasopressor property, it might contribute to prolongation of analgesia by reducing its local clearance4. This is a double blind randomized controlled study in which 114 patients of ASA I and II patient, of either sex, aged between 18-65 years, with lower limb surgeries requiring sub-arachanoid block will be randomized into three groups of 38 each. Group R will receive hyperbaric 0.75% ropivacaine, Group RM1will receive hyperbaric 0.75% ropivacaine with 100 mcgm morphine and Group RM2 will receive hyperbaric 0.75% ropivacaine with 200 mcgm morphine. The primary objective is to determine the analgesia duration and secondary objective is to determine the efficacy of respective drugs in terms of onset and duration of sensory and motor blockade along with two dermatomal segment regression,and any side effect in each group

Recruitment & Eligibility

Inclusion Criteria

American society of Anaesthesiologists (ASA) grade I/II patients undergoing lower limb orthopedic surgical procedures under spinal anaesthesia. Age group:18.
65 years of any sex. Patient voluntary participate in the study.

Exclusion Criteria

Contraindication to spinal anaesthesia.
History of allergy to morphine or ropivacaine.
Patients with severe psychiatric disorder such as depression, dementia or drugs which could interfere with the comprehension of the study.
Patients with history of any cardiac disease, coagulopathy or any respiratory disorder.

Primary Outcome Measures

Name	Time	Method
Primary outcome will be to evaluate the need for first analgesic dose.	Post operatively after 2 hours.

Secondary Outcome Measures

Name	Time	Method
the secondary outcome will be to assess the onset and duration of sensory and motor blockade along with hemodynamic parameters and side effects	Immediately after spinal anaesthesia

Locations (1): Bhagat phool singh govt medical college
🇮🇳
Sonipat, HARYANA, India
Bhagat phool singh govt medical college
🇮🇳Sonipat, HARYANA, India
Dr Shivani Meena
Principal investigator
9897596682
meenashivani118@gmail.com