Clinical trial NCT06448845: A Comparative Study Between Arm Intravenous Regional Anesthesia Versus Forearm Intravenous Regional Anesthesia in Patients Undergoing Hand and Wrist Surgery
Official title: A Comparative Study Between Arm Intravenous Regional Anesthesia Versus Forearm Intravenous Regional Anesthesia in Patients Undergoing Hand and Wrist Surgery. A Randomized Comparative Prospective Clinical Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Intravenous Anesthetic Agent Overdose
Hand Injury Wrist
Keywords: Forearm Tourniquet, Intravenous Regional Anesthesia
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2024-06-07
Enrollment: 140
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: The primary aim of this study is to compare the analgesic effectivity of the arm intravenous regional anesthesia versus the forearm intravenous regional anesthesia.
timeFrame: surgery duration which is around 1.5 hour
Secondary outcomes:
measure: Tourniquet time
timeFrame: From start of inflation until deflation of the tourniquet during surgery time which may last up to 90 minutes.
measure: Onset time of analgesia
timeFrame: At injection of the local anaesthetic until complete blockade of the sensory nerves during surgery
measure: Tourniquet tolerance time
timeFrame: From start of inflation until deflation of the tourniquet during surgery
measure: Satisfaction with surgical conditions (bloodless field)
timeFrame: At the start of the surgical procedure
measure: Intraoperative pain score
timeFrame: Every 5 minutes up to 1.5 hours during the surgical procedure
measure: General satisfaction of the patient
timeFrame: Assessed on day 1 post surgery
measure: Postoperative pain score: Numeric Rating Scale(NRS)
timeFrame: Patients will be observed and data recording will be done every 2 hours for the first 24 hours for postoperative pain
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain shams university hospitals
state: Abbasia
Study officials:
References: