Skip to content

Effect of hematoma block in intravenous regional anesthesia

Effect of intravenous regional anesthesia with single-cuff forearm area tourniquet and hematoma block in reduction of intra and postoperative pain in patients with distal radial bone fracture

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT201604223213N4
Enrollment
28
Registered
2016-08-06
Start date
2016-08-10
Completion date
Unknown
Last updated
2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fracture of lower end of radius. Fracture of lower end of radius

Interventions

Intervention 1: Control group: Classical Bier block will be performed by 3 mg/kg lidocaine. Intervention 2: Intervention group: patients will undergo Bier block with forearm tourniquet and 1.5 mg/kg l
Treatment - Drugs
Control group: Classical Bier block will be performed by 3 mg/kg lidocaine.
Intervention group: patients will undergo Bier block with forearm tourniquet and 1.5 mg/kg lidocaine combined with hematoma block (using 10 ml of 0.5% bupivacaine).

Sponsors

Vice Chancellor for Research, Shiaz University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: 18-70 years old age patients with distal fracture of radial bone who are candidate for reduction and closed pinning; years of age; ASA 1 and 2 Exclusion criteria: Peripheral neuropathy; sickle cell anemia; Reynaud disease; G6PD deficiency ; history of uncontrolled seizure; local infection or open wound in traumatized limb; severe coagulation defect; pregnancy; long term analgesic consumption or opioid dependency; patient refusal; abnormality in hepatic or renal elimination systems; inability to learn numerical rating scale (NRS) or PCA pump usage; peripheral vascular disease; severely overweight or underweight (BMI less than 18.5 and more than 30) ; hypersensitivity to local anesthetic drugs.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Pain intensity during traction and reduction. Timepoint: once during reduction. Method of measurement: Numerical Rating Scale (NRS).;Pain intensity during the first 24 hour after operation. Timepoint: every 15 minutes for 1 hour, every hour till the end of 6th hour, every 2 hour till the end of 12th hour and then every 4 hour until the end of 24 hour after operation. Method of measurement: Numerical Rating Scale (NRS).

Secondary

MeasureTime frame
Time to the first request for analgesic. Timepoint: once at the moment of first request. Method of measurement: time elapsed from tourniquet deflation in minutes.;Time to the begining of tourniquet pain. Timepoint: once when the patient complained. Method of measurement: time elapsed from tourniquet inflation in minutes.;Total fentanyl administered during operation for tourniquet pain relieve. Timepoint: calculation of total fentanyl once at the end of operation. Method of measurement: total dosa in micrograms.;Frequency of occurence of symtoms of local anesthetic toxicity (convulsion, arrhythmia, tinnitus, perioral paresthesia, lightheadedness and vertigo). Timepoint: every 15 minutes during the first postoperative hour. Method of measurement: frequency (percent).;Administered morphine during the first 24 hour after operation. Timepoint: every 1 hour for 6 hours, every 2 hour till 12th hour and then every 4 hour till the end of the 24th hour after the operation. Method of measurement: injected dose in milligrams.;Frequency of occurence of morphine side effects (respiratory depression, pruritus, nausea and vomiting, urinary retention). Timepoint: every 4 hour after operation for 24 hours. Method of measurement: frequency (percent).;Patients` global satisfaction. Timepoint: once at the end of the study. Method of measurement: a 5 points scale: completely dissatisfied, dissatisfied, neutral, satisfied, completely satisfied.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactRamin Tagvidi

Shiraz University of Medical Sciences

r.tajvidi@yahoo.com+98 71 3647 4270

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026