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Early Versus Late Deflation of Distal Tourniquet in IVRA With and Without Ketorolac in Hand & Forearm Surgery

Primary Purpose

Hand Injuries With Intravenous Regional Anesthesia

Status
Active
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Group one ( lidocaine or control LE ) Early deflation
Group two ( lidocaine , ketorolac LKE ) Early deflation
Group three ( lidocaine or control LL ) Late deflation
Group four ( lidocaine , ketorolac LKL ) Late deflation
Sponsored by
Sohag University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Hand Injuries With Intravenous Regional Anesthesia

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • A normal healthy patient or A patient with mild systemic disease
  • Aged between 20 and 70 years
  • Male or female
  • Schedueled for hand or forearm surgery

Exclusion Criteria:

  • Severe Raynaud's Disease (intermittent arteriolar vasospasm of the distal limbs after cold or emotional stimuli).
  • Sickle Cell Disease (IVRA is relatively contraindicated, unless meticulous exsanguination of the limb takes place prior to cuff inflation).
  • Crush injury to the limb, IVRA may provoke further tissue damage secondary to hypoxia.
  • Patients should be fasting, as there may be a possibility of conversion to a general anaesthetic, alternatively the patient may require sedation in addition to IVRA to improve co-operation.
  • Psychic, uncooperative patients.
  • Patient refusal.

Sites / Locations

  • Sohag University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Group one ( lidocaine or control LE ) Early deflation

Group two ( lidocaine , ketorolac LKE) Early deflation

Group three ( lidocaine Or control LL ) Late deflation

Group four ( lidocaine , ketorolac LKL ) Late deflation

Arm Description

Patients in group one (lidocaine or control group LE = 20): will receive 2% lidocaine 3mg/kg (maximum 200 mg) then distal tourniquet deflation occurs after 20 minutes.

Patients in group two (lidocaine ketorolac LKE = 20): will receive 2% lidocaine 3mg/kg (maximum 200 mg) plus ketorolac 0.5mg/kg (maximum 30mg) then distal tourniquet deflation occurs after 20 minutes.

Patients in group three (lidocaine or control group LL = 20): will receive 2% lidocaine 3mg/kg (maximum 200 mg) then distal tourniquet deflation occurs after 40 minutes.

Patients in group four (lidocaine ketorolac LKL = 20): will receive 2% lidocaine 3mg/kg (maximum 200 mg) plus ketorolac 0.5mg/kg (maximum 30mg) then distal tourniquet deflation occurs after 40 minutes.

Outcomes

Primary Outcome Measures

Efficiency of intravenous regional anesthesia assessed by visual analogue scale
Assessment of lidocaine as anesthetic in IVRA on 40 participants on the quality of the sensorial and motor block .
Duration of intravenous regional anesthesia
Assessment of lidocaine as anesthetic in IVRA on 40 participants on the duration of the sensorial and motor block .
Efficacy of intravenous regional anesthesia as regard tolerance of tourniquet pain .
Assessment of lidocaine as anesthetic in IVRA on 40 participants as regard tourniquet pain during hand and forearm surgery .

Secondary Outcome Measures

Role of keterolac as adjuvant to lidocaine in intravenous regional anesthesia as intraoperative & postoperative analgesic
Assessment of ketorolac as analgesic to lidocaine for intravenous regional anesthesia ( IVRA ) in 40 participants as regard intraoperative and postoperative analgesa during hand and forearm surgery .

Full Information

First Posted
November 14, 2021
Last Updated
February 1, 2022
Sponsor
Sohag University
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1. Study Identification

Unique Protocol Identification Number
NCT05234619
Brief Title
Early Versus Late Deflation of Distal Tourniquet in IVRA With and Without Ketorolac in Hand & Forearm Surgery
Official Title
Early Versus Late Deflation of Distal Tourniquet in Intravenous Regional Anesthesia With and Without Ketorolac in Hand & Forearm Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 1, 2022 (Actual)
Primary Completion Date
June 1, 2022 (Anticipated)
Study Completion Date
June 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sohag University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Bier block , or intravenous regional anesthesia (IVRA), is a method of anesthesia for upper extremity surgeries. IVRA was first described by August Bier in 1908, and after a period of latency, it began to gain widespread use after Holmes reemphasized its use in 1963. Bier blocks are technically easy to perform, and the rates for successful anesthesia approach 98%. Furthermore, when compared with brachial plexus blocks for outpatient hand and upper extremity surgery, IVRA may realize lower costs and faster postanesthesia recovery. Although a reliable source of anesthesia, IVRA has been associated with some disadvantages. Some patients cannot tolerate the tourniquet-mediated arm pain, and there are also reports of neurologic injury and compartment syndrome caused by the tourniquet. Perhaps the most serious complications associated with IVRA relate to the potential systemic toxicity of the local anesthetics used. If the local anesthetic gains access to a patient's systemic circulation, the central nervous system (CNS) and cardiovascular system can be affected. The CNS is usually affected first, with symptoms including dizziness, tinnitus, perioral paresthesia, and seizures. Anesthetic-induced toxicity of the cardiovascular system may manifest as hypotension, bradycardia, arrhythmias, or cardiac arrest. Historically, the tourniquet used in IVRA is left inflated for a minimum of 20 minutes. Theoretically, this allows time for the local anesthetic to bind to the tissues and, consequently, prevent a large bolus of drug from entering the systemic circulation. However, this tourniquet time appears to be arbitrary, and no safe time interval between anesthetic drug injection and tourniquet deflation has been established.
Detailed Description
This is a prospective Cohort , controlled , single-blinded , randomized study will be carried out at the department of Anesthesia of Sohag University hospital . This study will be conducted on 80 trauma patients who will be present for both elective and emergency Hand and Forearm surgery .. The patients will be allocated to one of four groups : Early deflation occurs after 20 minutes of induction of IVRA Late deflation occurs after 40 - 60 minutes of induction of IVRA Group one ( lidocaine or control LE ) Early deflation Group two ( lidocaine , ketorolac LKE) Early deflation Group three ( lidocaine Or control LL ) Late deflation Group four ( lidocaine , ketorolac LKL ) Late deflation After establishing noninvasive arterial blood pressure, ECG, peripheral oxygen saturation monitoring, two venous cannulae will be inserted: one in a vein in the dorsum of operative hand and the other in the opposite hand for crystalloid infusion. The opposite arm will be elevated for 2 minutes, and using an Esmarch bandage, the venous capacitance of the arm will be emptied. Then, a double-pneumatic tourniquet will be applied. The proximal tourniquet will be inflated to a pressure of 250 mmHg and circulatory isolation of the arm will be confirmed by inspection, lack of radial pulse and failure of pulse oximetry tracing of ipsilateral index finger then Esmarch bandage will be released.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hand Injuries With Intravenous Regional Anesthesia

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group one ( lidocaine or control LE ) Early deflation
Arm Type
Active Comparator
Arm Description
Patients in group one (lidocaine or control group LE = 20): will receive 2% lidocaine 3mg/kg (maximum 200 mg) then distal tourniquet deflation occurs after 20 minutes.
Arm Title
Group two ( lidocaine , ketorolac LKE) Early deflation
Arm Type
Active Comparator
Arm Description
Patients in group two (lidocaine ketorolac LKE = 20): will receive 2% lidocaine 3mg/kg (maximum 200 mg) plus ketorolac 0.5mg/kg (maximum 30mg) then distal tourniquet deflation occurs after 20 minutes.
Arm Title
Group three ( lidocaine Or control LL ) Late deflation
Arm Type
Active Comparator
Arm Description
Patients in group three (lidocaine or control group LL = 20): will receive 2% lidocaine 3mg/kg (maximum 200 mg) then distal tourniquet deflation occurs after 40 minutes.
Arm Title
Group four ( lidocaine , ketorolac LKL ) Late deflation
Arm Type
Active Comparator
Arm Description
Patients in group four (lidocaine ketorolac LKL = 20): will receive 2% lidocaine 3mg/kg (maximum 200 mg) plus ketorolac 0.5mg/kg (maximum 30mg) then distal tourniquet deflation occurs after 40 minutes.
Intervention Type
Drug
Intervention Name(s)
Group one ( lidocaine or control LE ) Early deflation
Other Intervention Name(s)
Group one ( xyloxaine or control LE ) Early deflation
Intervention Description
This will be conducted on 20 trauma patients group one who will be present for both elective and emergency Hand and Forearm surgery After establishing noninvasive arterial blood pressure, ECG, peripheral oxygen saturation monitoring, two venous cannulae will be inserted: one in a vein in the dorsum of operative hand and the other in the opposite hand for crystalloid infusion. The opposite arm will be elevated for 2 minutes, and using an Esmarch bandage, the venous capacitance of the arm will be emptied. Then, a double-pneumatic tourniquet will be applied. The proximal tourniquet will be inflated to a pressure of 250 mmHg and circulatory isolation of the arm will be confirmed by inspection, lack of radial pulse and failure of pulse oximetry tracing of ipsilateral index finger then Esmarch bandage will be released then induction of lidocaine for intravenous regional anesthesia ( Bier block ) and Early deflation of distal tourniquet occurs after 20 minutes of IVRA induction
Intervention Type
Drug
Intervention Name(s)
Group two ( lidocaine , ketorolac LKE ) Early deflation
Other Intervention Name(s)
Group two ( xylocaine , Toradol LKE ) Early deflation
Intervention Description
As the first intervention this will be conducted on group two but ketorolac will be combined with lidocaine in intravenous regional anesthesia
Intervention Type
Drug
Intervention Name(s)
Group three ( lidocaine or control LL ) Late deflation
Other Intervention Name(s)
Group three ( xylocaine or control LL ) Late deflation
Intervention Description
As the first intervention this will be conducted on group three but late deflation of distal tourniquet in intravenous regional anesthesia after 40 minutes of induction of lidocaine for IVRA .
Intervention Type
Drug
Intervention Name(s)
Group four ( lidocaine , ketorolac LKL ) Late deflation
Other Intervention Name(s)
Group four ( xylocaine , toradol LKL ) Late deflation
Intervention Description
As the first intervention this will be conducted on group four but late deflation of distal tourniquet in intravenous regional anesthesia after 40 minutes of induction of lidocaine and ketorolac for IVRA .
Primary Outcome Measure Information:
Title
Efficiency of intravenous regional anesthesia assessed by visual analogue scale
Description
Assessment of lidocaine as anesthetic in IVRA on 40 participants on the quality of the sensorial and motor block .
Time Frame
6 months
Title
Duration of intravenous regional anesthesia
Description
Assessment of lidocaine as anesthetic in IVRA on 40 participants on the duration of the sensorial and motor block .
Time Frame
6 months
Title
Efficacy of intravenous regional anesthesia as regard tolerance of tourniquet pain .
Description
Assessment of lidocaine as anesthetic in IVRA on 40 participants as regard tourniquet pain during hand and forearm surgery .
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Role of keterolac as adjuvant to lidocaine in intravenous regional anesthesia as intraoperative & postoperative analgesic
Description
Assessment of ketorolac as analgesic to lidocaine for intravenous regional anesthesia ( IVRA ) in 40 participants as regard intraoperative and postoperative analgesa during hand and forearm surgery .
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: A normal healthy patient or A patient with mild systemic disease Aged between 20 and 70 years Male or female Schedueled for hand or forearm surgery Exclusion Criteria: Severe Raynaud's Disease (intermittent arteriolar vasospasm of the distal limbs after cold or emotional stimuli). Sickle Cell Disease (IVRA is relatively contraindicated, unless meticulous exsanguination of the limb takes place prior to cuff inflation). Crush injury to the limb, IVRA may provoke further tissue damage secondary to hypoxia. Patients should be fasting, as there may be a possibility of conversion to a general anaesthetic, alternatively the patient may require sedation in addition to IVRA to improve co-operation. Psychic, uncooperative patients. Patient refusal.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed E Elsaeed
Organizational Affiliation
Head of Anesthesiology & intensive care unit department
Official's Role
Study Director
Facility Information:
Facility Name
Sohag University Hospital
City
Sohag
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Early versus Late deflation of Distal tourniquet in Intravenous Regional Anesthesia With and without Ketorolac in Hand & Forearm surgery
IPD Sharing Time Frame
6 months
IPD Sharing Access Criteria
Early versus Late deflation of Distal tourniquet in Intravenous Regional Anesthesia With and without Ketorolac in Hand & Forearm surgery
Citations:
PubMed Identifier
18749978
Citation
Rosen MA. Anesthesiology: bupivacaine toxicity. West J Med. 1986 May;144(5):598-9. No abstract available.
Results Reference
background
PubMed Identifier
20122591
Citation
Guay J. Adverse events associated with intravenous regional anesthesia (Bier block): a systematic review of complications. J Clin Anesth. 2009 Dec;21(8):585-94. doi: 10.1016/j.jclinane.2009.01.015.
Results Reference
background
PubMed Identifier
24591833
Citation
Zahavi GS, Dannon P. Comparison of anesthetics in electroconvulsive therapy: an effective treatment with the use of propofol, etomidate, and thiopental. Neuropsychiatr Dis Treat. 2014 Feb 20;10:383-9. doi: 10.2147/NDT.S58330. eCollection 2014.
Results Reference
background

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Early Versus Late Deflation of Distal Tourniquet in IVRA With and Without Ketorolac in Hand & Forearm Surgery

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