AnesthesiaNCT06214169
Effect of Addition of Cisatracurium to Lidocaine VS Plain Lidocaine
A study testing Cisatracurium Besylate and Lignocaine in people with Anesthesia, run by Watim Medical & Dental College at 1 site in Pakistan.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 55 years
- Conditions the study is for
- Anesthesia
- What is being tested?
- Cisatracurium Besylate and Lignocaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Jun 2023to 20 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- All ASA physical status I \& II patients between 20 to 55 years of age, scheduled for elective hand surgery
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Combined Millitary Hospital
Rawalpindi, Punjab Province, 46000
About this study
Official title: Effect of Addition of Cisatracurium to Lidocaine VS Plain Lidocaine for Intravenous Regional Anesthesia, a Comparative Study
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.
- Conditions
- Anesthesia
- Being tested
- Cisatracurium Besylate, Lignocaine
- Keywords
- Cisatracurium, Intravenous Regional Anesthesia, Lignocaine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cisatracurium BesylateDrug
Addition of cisatracurium to plain lignocaine for IVRA.
LignocaineDrug
Plain Lignocaine for IVRA
| Study group | Role | What they receive |
|---|---|---|
| Plain Lignocaine group | Other | Group of participants receiving only plain lignocaine for IVRA Receives: Drug: Lignocaine |
| Cisatracurium group | Other | Group of participants receiving plain lignocaine and cisatracurium combined for IVRA Receives: Drug: Cisatracurium Besylate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to onset of Sensory blockade.
Sensory block will be assessed by pinprick in the dermatomal sensory distribution and time noted for complete sensory blockade.
Measured: 1-5 min.
Time to onset of Motor Blockade
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.
Measured: 2-7 min.
Intraoperative Pain Scoring
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.
Measured: 5-45 min.
Regression of sensory blockade
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.
Measured: 2-10 min post deflation.
Regression of motor blockade
Motor block regression time (the time elapsed from tourniquet deflation until regaining of flexion and extension of wrist and fingers) will be noted.
Measured: 2-10 min post deflation
Postop Pain scoring
Postoperative pain will be assessed by VAS at 5 minutes after tourniquet deflation and at 1, 2, 4, 8 hours postoperatively.
Measured: 5 minutes post deflaton till 8 hours post deflation.
Time to first analgesic request post operatively.
The first analgesic dose requirement time will also be noted (the time elapsed from tourniquet release until first request for analgesic medication postoperatively)
Measured: 1 hour - 8 hours post deflation.
Side Effects
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.
Measured: From onset of blockade to 8 hours post operatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2024
- Study start15 Jun 2023
- Primary completion20 Dec 2023
- Study completion20 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Watim Medical & Dental College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammad Ilyas, Watim Medical & Dental College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06214169
- Sponsor's protocol ID
- 446/23
- Status last verified
- Jan 2024
- First submitted
- 26 Dec 2023
- Last updated
- 19 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Prabhakar A, Lambert T, Kaye RJ, Gaignard SM, Ragusa J, Wheat S, Moll V, Cornett EM, Urman RD, Kaye AD. Adjuvants in clinical regional anesthesia practice: A comprehensive review. Best Pract Res Clin Anaesthesiol. 2019 Dec;33(4):415-423. doi: 10.1016/j.bpa.2019.06.001. Epub 2019 Jul 2.
PubMed 31791560Esmaoglu A, Akin A, Mizrak A, Turk Y, Boyaci A. Addition of cisatracurium to lidocaine for intravenous regional anesthesia. J Clin Anesth. 2006 May;18(3):194-7. doi: 10.1016/j.jclinane.2005.08.003.
PubMed 16731321Farbood A, Khademi S, Tajvidi R, Hooshangi M, Salari S, Ghani M, Tahmasebi S, Jamali H. Comparison of Intravenous Regional Anesthesia with Single-Cuff Forearm Tourniquet and Hematoma Block and Traditional Method in Patients with Distal Radius Fractures; A Randomized Clinical Trial. Bull Emerg Trauma. 2020 Apr;8(2):77-82. doi: 10.30476/BEAT.2020.46446.
PubMed 32420391
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Addition of Cisatracurium to Lidocaine VS Plain Lidocaine for Intravenous Regional Anesthesia, a Comparative Study
- ClinicalTrials.gov ID
- NCT06214169
- Acronym / sponsor ID
- 446/23
- Conditions
- Anesthesia
- Keywords
- Cisatracurium, Intravenous Regional Anesthesia, Lignocaine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Watim Medical & Dental CollegeUniversity, hospital or other
- Study start
- 15 Jun 2023 (actual)
- Primary completion
- 20 Dec 2023 (actual)
- Study completion
- 20 Dec 2023 (actual)
- First posted
- 19 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Plain Lignocaine group | Other | Drug: LignocaineGroup of participants receiving only plain lignocaine for IVRA |
| Cisatracurium group | Other | Drug: Cisatracurium BesylateGroup of participants receiving plain lignocaine and cisatracurium combined for IVRA |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- All ASA physical status I \& II patients between 20 to 55 years of age, scheduled for elective hand surgery
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cisatracurium BesylateAddition of cisatracurium to plain lignocaine for IVRA. | Drug | Cisatracurium group |
| LignocainePlain Lignocaine for IVRA | Drug | Plain Lignocaine group |
Primary outcome
Time to onset of Sensory blockade.
Time frame: 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 Blockade
Time frame: 2-7 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 Scoring
Time frame: 5-45 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 blockade
Time frame: 2-10 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 blockade
Time frame: 2-10 min post deflation
Motor block regression time (the time elapsed from tourniquet deflation until regaining of flexion and extension of wrist and fingers) will be noted.
Postop Pain scoring
Time frame: 5 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.
Time frame: 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 Effects
Time frame: From 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2024.
- Background: PubMed 31791560Prabhakar A, Lambert T, Kaye RJ, Gaignard SM, Ragusa J, Wheat S, Moll V, Cornett EM, Urman RD, Kaye AD. Adjuvants in clinical regional anesthesia practice: A comprehensive review. Best Pract Res Clin Anaesthesiol. 2019 Dec;33(4):415-423. doi: 10.1016/j.bpa.2019.06.001. Epub 2019 Jul 2.
- Background: PubMed 16731321Esmaoglu A, Akin A, Mizrak A, Turk Y, Boyaci A. Addition of cisatracurium to lidocaine for intravenous regional anesthesia. J Clin Anesth. 2006 May;18(3):194-7. doi: 10.1016/j.jclinane.2005.08.003.
- Background: PubMed 32420391Farbood A, Khademi S, Tajvidi R, Hooshangi M, Salari S, Ghani M, Tahmasebi S, Jamali H. Comparison of Intravenous Regional Anesthesia with Single-Cuff Forearm Tourniquet and Hematoma Block and Traditional Method in Patients with Distal Radius Fractures; A Randomized Clinical Trial. Bull Emerg Trauma. 2020 Apr;8(2):77-82. doi: 10.30476/BEAT.2020.46446.
- Individual participant dataSharing planned: No
Related trials for Anesthesia
Not yet recruitingObservational study
"Comparison of Oxygen Reserve Index (ORI), End-Tidal Oxygen, and Time-Based Preoxygenation Targets With Arterial Blood Gas During Preoxygenation
Preoxygenation Adequacy Assessed by Oxygen Reserve Index, End-tidal Oxygen and Arterial Blood Gas
RecruitingObservational study
Comparison of Hemodynamic Responses During Anesthesia Induction Using Eleveld and Schnider
Spinal (Fusion) Surgery, Total Intravenous Anesthesia
Not yet recruiting
A Randomized Controlled SaCo-VLM Trial
General Anaesthesia Using Supraglotic Airway
Not yet recruiting
Bispectral Index-Guided Propofol Sedation During Endoscopic Retrograde Cholangiopancreatography
Deep Sedation, Endoscopic Retrograde Cholangiopancreatography
RecruitingPhase 4
Comparison of Hemodynamics and Respiratory Function Between Ciprofol and Propofol in Elderly Patients Undergoing Non-intubated General Anesthesia
Comparison of Hemodynamics and Respiratory Function Between Ciprofol and Propofol in Elderly Patients Undergoing Non-intubated General Anesthesia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cisatracurium Besylate and Lignocaine in people with Anesthesia, run by Watim Medical & Dental College at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to onset of Sensory blockade. (time frame: 1-5 min.). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06214169, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2024.