Clinical trial

Effect of Addition of Cisatracurium to Lidocaine VS Plain Lidocaine for Intravenous Regional Anesthesia, a Comparative Study

Name
446/23
Description
The goal of this Randomized Control Trial is to compare the effects of addition of cisatracurium to lignocaine for IVRA Vs. Plain lignocaine in All ASA physical status I \& II patients between 20 to 55 years of age, scheduled for elective hand surgery (carpal tunnel, trigger finger, tendon release, fracture reduction and tendon repair). The main question\[s\] it aims to answer are: • Does addition of Cisatracurium to plain lignocaine improve the overall quality of anesthesia? • Does use of cisatracurium lead to improved postop analgesia and decreased parenteral analgesic requirements? Participants will be Forty-four patients undergoing elective hand surgery during IVRA randomly assigned to two groups of 22 patients each. All demographic details (age, gender, body weight) will be noted, all will be briefed about visual analogue score (0 to 10) for pain. Group 1 (control group) will receive lidocaine 2% diluted with saline, group 2 (cisatracurium group) will receive cisatracurium plus lidocaine 2% diluted with saline. A standard technique would be employed for IVRA. The following parameters to be assessed: onset and offset of sensory and motor block, Intra-operative pain at 5, 10, 20, 30 minutes after tourniquet application by using visual analogue score (VAS), and postoperative pain using visual analogue score (VAS) measured at 5-minute,1, 2, 4, 8 hours postoperatively.
Trial arms
Trial start
2023-06-15
Estimated PCD
2023-12-20
Trial end
2023-12-20
Status
Completed
Treatment
Cisatracurium Besylate
Addition of cisatracurium to plain lignocaine for IVRA.
Arms:
Cisatracurium group
Lignocaine
Plain Lignocaine for IVRA
Arms:
Plain Lignocaine group
Size
44
Primary endpoint
Time to onset of Sensory blockade.
1-5 min.
Time to onset of Motor Blockade
2-7 min.
Intraoperative Pain Scoring
5-45 min.
Regression of sensory blockade
2-10 min post deflation.
Regression of motor blockade
2-10 min post deflation
Postop Pain scoring
5 minutes post deflaton till 8 hours post deflation.
Time to first analgesic request post operatively.
1 hour - 8 hours post deflation.
Side Effects
From onset of blockade to 8 hours post operatively.
Eligibility criteria
Inclusion Criteria: * All ASA physical status I \& II patients between 20 to 55 years of age, scheduled for elective hand surgery Exclusion Criteria: * Patients with Raynaud disease, sickle cell anemia, or a history of allergy to any drug to be used. * Also, patients who had bleeding tendency, on anticoagulant or antiplatelet therapy, significant cardiovascular, peripheral vascular, or neurological disease.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 44, 'type': 'ACTUAL'}}
Updated at
2024-01-19

1 organization

2 products

1 indication

Indication
Anesthesia
Product
Lignocaine