Skip to content

Effect of Addition of Cisatracurium to Lidocaine VS Plain Lidocaine

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06214169
Enrollment
44
Registered
2024-01-19
Start date
2023-06-15
Completion date
2023-12-20
Last updated
2024-01-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia

Keywords

Cisatracurium, Intravenous Regional Anesthesia, Lignocaine

Brief summary

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.

Interventions

Addition of cisatracurium to plain lignocaine for IVRA.

Plain Lignocaine for IVRA

Sponsors

Watim Medical & Dental College
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
20 Years to 55 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Time to onset of Sensory blockade.1-5 min.Sensory block will be assessed by pinprick in the dermatomal sensory distribution and time noted for complete sensory blockade.
Time to onset of Motor Blockade2-7 min.Motor block will be assessed by asking the subject to flex and extend his/her wrist and fingers, every 30 seconds and time to be noted till inability to flex or extend the wrist and fingers is confirmed and time noted.
Intraoperative Pain Scoring5-45 min.The severity of intraoperative pain will be assessed using 10 point VAS (Visual Analogue Score) with 1 being no pain and 10 being the worst possible pain at 5, 10, 20, 30 minutes after tourniquet application.
Regression of sensory blockade2-10 min post deflation.Sensory blockade regression time (the time elapsed from tourniquet deflation to recovery of complete sensation in all dermatomes, determined by pinprick test) , will be noted.
Regression of motor blockade2-10 min post deflationMotor block regression time (the time elapsed from tourniquet deflation until regaining of flexion and extension of wrist and fingers) will be noted.
Postop Pain scoring5 minutes post deflaton till 8 hours post deflation.Postoperative pain will be assessed by VAS at 5 minutes after tourniquet deflation and at 1, 2, 4, 8 hours postoperatively.
Time to first analgesic request post operatively.1 hour - 8 hours post deflation.The first analgesic dose requirement time will also be noted (the time elapsed from tourniquet release until first request for analgesic medication postoperatively)
Side EffectsFrom onset of blockade to 8 hours post operatively.Incidence of side effects such as tinnitus, dizziness, convulsions, gastric discomfort, muscle weakness and bleeding tendency will be recorded intraoperatively as well as during recovery from blockade.

Countries

Pakistan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026