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

NCT ID: NCT06448845

Last Updated: 2024-06-07

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-01
• Study Completion Date: 2025-03-01

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.

Detailed Description

Several ways of anesthesia can be used to perform hand surgery, being general anesthesia, intravenous regional anesthesia as well as locoregional anesthesia. Locoregional anesthesia and intravenous regional anesthesia are often performed since patients can be discharged from the hospital more rapidly. A conventional Biers block is performed using a tourniquet on the upper arm to create a bloodless field and to contain the anesthetics within the surgical area.

A mini-Biers block in which the tourniquet is placed on the forearm, has been shown to be a safe and effective way of anesthesia to perform hand and wrist surgery. By using this type of anesthesia, the dose of the anesthetic can be reduced compared to a conventional Bier's block which reduces the risk of systemic toxicity reactions.

Intravenous regional anesthesia (IVRA) or Bier's Block is a simple and effective but underused anesthetic technique for hand and wrist surgery, This technique, introduced by Dr.August Bier in1908, provides complete anesthesia as well as a bloodless field during surgery.

Traditionally, an upper arm tourniquet has been used to sequester the local anesthetic and to create a bloodless Surgical field. Major complications after IVRA with an upper arm tourniquet are rare but are mostly related to local anesthetic systemic toxicity after release of the tourniquet.

Use of a forearm tourniquet has been introduced in 1978 and comes with the big advantage of lower (non-toxic) local anesthetic dosage requirement to produce a good quality of analgesia.

Consequently, there is no minimal tourniquet inflation time after forearm IVRA. In addition ,it has been postulated that sensory onset time after forearm IVRA may be shorter than after upper arm IVRA. With these two features forearm IVRA may be the ideal anesthetic technique for short surgery of hand and wrist.

Conditions

Intravenous Anesthetic Agent Overdose; Hand Injury Wrist

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group A (Arm IVRA) 70 patients

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.

Group Type: ACTIVE_COMPARATOR

Arm intravenous regional anesthesia

Intervention Type: 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)

Group F (Forearm IVRA) 70 patients

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.

Group Type: ACTIVE_COMPARATOR

Forearm IVRA block

Intervention Type: 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.

Interventions

Arm intravenous regional anesthesia

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)

Intervention Type: PROCEDURE

Forearm IVRA block

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.

Intervention Type: PROCEDURE

Other Intervention Names

Bier's Block; Mini Bier's Block

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Ain shams university hospitals

Cairo, Abbasia, Egypt

Countries

Egypt

Other Identifiers

FMASU MD 148/2023

Identifier Type: -

Identifier Source: org_study_id