A study to compare the effects of two different drugs (Morphine and Dexmedetomidine) given as spinal anaesthesia to reduce post-operative pain in liver and pancreas surgeries

Not yet recruiting

Conditions: Disorders of gallbladder, biliarytract and pancreas in diseases classified elsewhere, (2) ICD-10 Condition: K769||Liver disease, unspecified,

Registration Number: CTRI/2021/09/036936

Lead Sponsor: CMC vellore

Brief Summary: Adequate analgesia provided in upper abdominalsurgeries helps to enhance recovery, decrease post-operative morbidity and decreasethe length of hospital stay. The standard of care in managing post- operativepain in upper abdominal surgeries has the been the use of thoracic epidural analgesia.However, an increased risk of postoperative coagulopathy after hepatectomies,prolonged immobilization, urinary retention, hypotension, and an increasedchance of anastomotic leak with thoracic epidural analgesia in the post-operativeperiod has made it less favorable.

Intrathecal morphine has proved an alternative toepidural analgesia providing effective postoperative analgesia withsignificantly lower adverse effects and risks and shown a reduced requirementfor intravenous opioids. Intrathecal morphine has a proven worth inhepatobiliary surgery. However, there is an added risk of respiratory depression.

Dexmedetomidine, a specific and selective alpha-2 adrenoreceptoragonist produces dose dependent anxiolysis, sedation and longer duration ofanalgesia with no respiratory depression. Intrathecal dexmedetomidine has beenstudied in lower abdominal and lower limb surgeries where it prolongs theaction of bupivacaine and has extended postoperative analgesia.

Our study intends to compare postoperative analgesiain hepato-pancreatic surgeries where there is still a paucity of sufficientdata.

The use of intrathecal dexmedetomidine could emergeas a promising alternative to epidural analgesia in the future for betterpatient outcome among hepatic and pancreatic surgeries.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 100

Inclusion Criteria

1.Patients undergoing hepatopancreatic surgeries 2.ASA I and II 3.Age >18years.

Exclusion Criteria

1.Patient Refusal 2.ASA III and IV 3.Contraindications to spinal Anaesthesia 4.Patients on Beta blockers 5.Known allergy to study drugs.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Postoperative pain score assessment using Numerical Rating Scale (NRS)	Postoperative pain score assessment using Numerical Rating Scale (NRS) baseline and every Q6h for 48 hours

Secondary Outcome Measures

Name	Time	Method
1.Intraoperative hemodynamics	2.Time to awaken

Trial Locations

Locations (1): CMC Vellore
🇮🇳
Vellore, TAMIL NADU, India
CMC Vellore
🇮🇳Vellore, TAMIL NADU, India
Andrea Grace Oommen
Principal investigator
8825816947
andreaoommen@gmail.com