A Comparative Study Between Arm Intravenous Regional Anesthesia Versus Forearm Intravenous Regional Anesthesia in Patients Undergoing Hand and Wrist Surgery

NCT06448845 | Active Not Recruiting

• 1 other identifier: FMASU MD 148/2023
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

The technique of intravenous regional analgesia using a tourniquet consisting of two cuffs over the upper arm is a well-known procedure, With the tourniquet being conventionally placed over the upper arm, a relatively high dose of local anaesthetic drug is required and occasionally systemic toxic reactions have occurred. The purpose of the present study is to establish the efficacy of the technique of intravenous regional analgesia with a forearm tourniquet using reduced doses of lidocaine.

Conditions

Intravenous Anesthetic Agent Overdose; Hand Injury Wrist

Keywords

Forearm Tourniquet, Intravenous Regional Anesthesia

Outcome Measures

Primary Outcomes (1)

• The primary aim of this study is to compare the analgesic effectivity of the arm intravenous regional anesthesia versus the forearm intravenous regional anesthesia.

  the analgesic effectivity of these techniques (graded as "complete" or "incomplete") and divide the effectivity in 4 grades. Grade 1 and grade 2 will be considered "complete" blockade, while grade 3 and grade 4 will be considered "incomplete" blockade. Grade 1: complete motor and sensory blockade. Grade 2: partial motor blockade but no pain. Grade 3: partial motor blockade with mild pain requiring rescue local or opioid analgesia. Grade 4: incomplete motor and sensory blockade requiring sedation/conversion to general anesthesia.

  surgery duration which is around 1.5 hour

Secondary Outcomes (7)

• Tourniquet time

  From start of inflation until deflation of the tourniquet during surgery time which may last up to 90 minutes.

• Onset time of analgesia

  At injection of the local anaesthetic until complete blockade of the sensory nerves during surgery

• Tourniquet tolerance time

  From start of inflation until deflation of the tourniquet during surgery

• Satisfaction with surgical conditions (bloodless field)

  At the start of the surgical procedure

• Intraoperative pain score

  Every 5 minutes up to 1.5 hours during the surgical procedure

Study Arms (2)

Group A (Arm IVRA) 70 patients

ACTIVE COMPARATOR

After placement of the upper arm and forearm tourniquets and exsanguination of the limb distal to the cuff by applying an Esmarch's bandage starting from the fingertips, the arm tourniquet cuff is inflated to a pressure of 250 mmHg. The double arm cuff pneumatic pressure tourniquet is placed immediately above the elbow crease and on the top of a circumferentially placed cotton cast padding before inflation.

Procedure: Arm intravenous regional anesthesia

Group F (Forearm IVRA) 70 patients

ACTIVE COMPARATOR

After placement of the forearm double tourniquet and exsanguination of the limb distal to the cuff by applying an Esmarch's bandage starting from the fingertips, the forearm tourniquet cuff is inflated to a pressure of 250 mmHg. The forearm tourniquet will be placed 5 cm distal to the medial epicondyle of the humerus and on the top of a circumferentially placed cotton cast.

Procedure: Forearm IVRA block

Interventions

Arm intravenous regional anesthesia PROCEDURE

After placement of the upper arm and forearm tourniquets and exsanguination of the limb distal to the cuff by applying an Esmarch's bandage starting from the fingertips, the arm tourniquet cuff is inflated to a pressure of 250 mmHg. The double arm cuff pneumatic pressure tourniquet is placed immediately above the elbow crease and on the top of a circumferentially placed cotton cast padding before inflation. Subsequently, tourniquet failure is ruled out by observing the absence of distal circulation and 40 ml 0.5% lidocaine is slowly injected through the intravenous cannula on the dorsum of the hand. The tourniquet remained inflated for 60 minutes from injection of lidocaine to reduce the risk of local anesthetic systemic toxicity (LAST)

Also known as: Bier's Block

Group A (Arm IVRA) 70 patients

Forearm IVRA block PROCEDURE

After placement of the forearm double tourniquet and exsanguination of the limb distal to the cuff by applying an Esmarch's bandage starting from the fingertips, the forearm tourniquet cuff is inflated to a pressure of 250 mmHg. The forearm tourniquet will be placed 5 cm distal to the medial epicondyle of the humerus and on the top of a circumferentially placed cotton cast. Subsequently, tourniquet failure is ruled out by observing the distal circulation and 25 ml 0.5% lidocaine is slowly injected through the intravenous cannula on the dorsum of the hand.

Also known as: Mini Bier's Block

Group F (Forearm IVRA) 70 patients

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients of American Society of Anesthesiologists (ASA) physical status I to II.
• Both sexes.
• ≥ 21 to 65 years.
• scheduled for elective hand and wrist surgeries.

You may not qualify if:

• American society of Anesthesiologists (ASA) physical status ≥3 or BMI ≥40
• Patients will do bilateral hand surgery
• Local site infection.
• Allergy to local anesthetics.
• Patient refusal
• Patients with pre-existing myopathy or neuropathy on the operating limb.
• Patients with significant cognitive dysfunction.
• Chronic analgesic abuser patients.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain shams university hospitals

Cairo, Abbasia, 11566, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2024
• First Posted: June 7, 2024
• Study Start: January 1, 2024
• Primary Completion: January 1, 2025
• Study Completion: March 1, 2025
• Last Updated: June 7, 2024

Record last verified: 2024-05

Locations

EG (1)