Efficacy of morphine and dexmedetomidine as adjuvants to levobupivacaine in spinal anaesthesia for abdominal hysterectomy

Not Applicable

Completed

Conditions: All participant will either be ASA ( American Society of Anaesthesiologist ) grade 1 or 2

Registration Number: CTRI/2018/01/011178

Lead Sponsor: AIIMS Raipur

Brief Summary: Morphine is widely used an adjuvant to regional anaesthesia for post-operative analgesia because of its prolonged post-operative analgesic effects. It is associated with side effects like nausea, vomiting, pruritus, urinary retention and- most feared - respiratory depression.

Dexmedetomidine now emerging as an adjuvant to regional anaesthesia, Intrathecal dexmedetomidine when combined with local anesthetic prolongs the sensory block by depressing the release of C-fibre transmitters and by hyperpolarization of postsynaptic dorsal horn neurons. Motor block prolongation by Î±2 adrenergic agonist may result from binding of Î±2 agonists to motor neurons in the dorsal horn of the spinal cord.

The primary aim of the study is to compare analgesic efficacy of these two adjuvants simultaneously observing the adverse effects, characteristics of spinal block and perioperative vital parameters.

Seventy patients between 18 to 60 years of age, posted for abdominal hysterectomy under subarachnoid block with isobaric 0.5% levobupivacaine, will be recruited.

**Intervention and Study Groups**

Patients will be randomly allocated to two groups (group M & group D) of 35 each by computer generated list. Group M will receive 3 ml of 0.5% isobaric levobupivacaine with morphine & Group D will receive 3 mL of 0.5% isobaric levobupivacaine with dexmedetomidine. After performing spinal block, the vital signs will be recorded every 5 min for the first 30 min, every 15 min for the next hour and thereafter, half hourly till the request for supplemental analgesia

**Implication of the Study**

Dexmedetomidine may be having equal or even better analgesia with better side effect profile in comparison to morphine and hence may become adjuvant drug of choice for various abdominal surgeries done under spinal anaesthesia.

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Female

Target Recruitment: 70

Inclusion Criteria

1. ASA 1 or 2 patients 2. 18.
60 yrs of age 3. Patient undergoing abdominal hysterectomy under subarachnoid block.

Exclusion Criteria

a)Patients with contraindications for spinal anaesthesia b)ASA grade III and above c)Known allergy to any of the study medications d)Acute or chronic respiratory disease e)Hypertension or other cardiovascular abnormalities f)Cognitive or psychiatric disturbances g)Patients taking Î± adrenergic receptor antagonist, ACE inhibitors, angiotensin receptor blockers, chronic opioid therapy.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
we will compare analgesic efficacy of two drugs which are used for control of pain for hysterectomy	intraoperative and postoperative upto 24 hrs

Secondary Outcome Measures

Name	Time	Method
Adverse effects	Vital parameters

Trial Locations

Locations (1): O. T. Complex, Department of Anaesthesiology, AIIMS Raipur
🇮🇳
Raipur, CHHATTISGARH, India
O. T. Complex, Department of Anaesthesiology, AIIMS Raipur
🇮🇳Raipur, CHHATTISGARH, India
Dr Mayank Kumar
Principal investigator
9971760416
mayanksonupmch@gmail.com