Compare the pain relief effect of dexmedetomidine and dexamethasone as an additive to ropivacaine in ultrasound guided block for gall bladder surgeries

Not Applicable

Not yet recruiting

• Conditions: Cholecystitis,

• Registration Number: CTRI/2023/08/056800
• Lead Sponsor: Maulana Azad Medical College and associated Lok Nayak ,G.N.E.C.,G.I.P.M.E.R Hospitals,New Delhi

Brief Summary

We are comparing the analgesic effect of dexmedetomidine and dexamethasone as an  adjuvant to ropivacaine in ultrasound guided erector spinae plane block for laparoscopic cholecystectomy in patients between the age of 18 to 65 yrs. Erector spinae plane block will be given bilaterally before standard general anaesthesia induction to patients undergoing laparoscopic cholecystectomy .The aim of the study is to compare the analgesic effect of two groups .Two groups are   DX- 0.2% ropivacaine with dexamethasone(10mg) ,  DM - 0.2% ropivacaine with dexmedetomidine (0.5mcg/kg). patients will be assigned into two groups by randomisation using lottery method, into  groups DX and DM. Postoperative pain using  NRS score at various time intervals in both groups will be noted, also 1)The time at which the first rescue analgesia will be requested post operatively in both groups 2) Total amount of analgesic consumption within 24 hours postoperatively in both groups 3) Time of initiation of ambulation. 4) Respiratory Function(FEV1, FVC, FEV1/FVC and PEFR) pre-operatively and24hrspost-operatively using hand held spirometer. 5) Incidence of post operative nause and vomiting PONV6) Patient satisfaction will also be noted.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2023-08-21
• Study Start: 2023-08-30

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1)18 to 65 years of age undergoing laparoscopic cholecystectomy 2)Patients of ASA I and II.

Exclusion Criteria

• 1)Patient refusal.
• 2)Bleeding diathesis.
• 3)Local skin infection at the site of block.
• 4)Psychiatric disorder or risk of psychiatric disease.
• 5)Laparoscopic cholecystectomy turned to open cholecystectomy.
• 6)Any allergy to local anaesthetics or adjuvants dexmedetomedine/dexamethasone.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Postoperative pain using NRS score at various time intervals in both groups.	0 mins | 30 mins | 1 hours | 2 hours | 6 hours | 12 hours | 24hours

Secondary Outcome Measures

Name	Time	Method
1)The time at which the first rescue analgesia will be requested post operatively in both groups	2) Total amount of analgesic consumption within 24 hours postoperatively in both groups

Trial Locations

Locations (1)

Lok Nayak Hospital; 🇮🇳 Central, DELHI, India

Lok Nayak Hospital

🇮🇳Central, DELHI, India

Ezhukattil Reshma James

Principal investigator

8076987148

ezhukattilreshma@yahoo.com