Addition of Drugs to Prolong The Effect of Blocks For Arm Surgery.

Phase 2/3

Completed

• Conditions: patients with fracture of lower end of bone of arm and or fractures of bones of forearm, undergoing surgery for open reduction and Internal fixation

• Registration Number: CTRI/2015/05/005825
• Lead Sponsor: Dr Rajendra Prasad Govt Medical College Tanda Kangra Himachal Pradesh

Brief Summary

Upper limb surgeries are performed under the peripheral nerve block as they not only provide adequate intraoperative and postoperative  analgesia but also avoid the complications associated with the general anaesthesia.Use of the Ultrasound guided peripheral nerve block is relatively a new technique that is gaining popularity over more traditional technique of peripheral nerve stimulator and parasthesia.

The upper limb can be successfully blocked using interscalene, supraclaviular, infraclavicular and axillary approach.Various drugs like bupivacaine, ropivacaine and mepivacaine have been used in supraclavicular brachial block to  achieve adequate analgesia,

Various adjuvants like alpha 2 agonists- clonidine and dexmedetomidine, adrenaline, fentanyl and midazolam have been added to these drugs to prolong duration of block and to achieve more dense block. Clonidine an alpha 2 adrenoceptornagonist has a peripheral and central antinociceptive properties.Alpha 2 adrenoceptors are located on the primary afferent terminals implicated in analgesia.It supports analgesic action at peripheral sites.

Dexmedetomidine , a selective alpha 2 receptor agonist have been used as an adjuvant during regional anaesthesia. animal and human studies show safety and efficacy of adding dexmedetomidine to local anaesthetic .

As no study has compared the effect if dexmedetomidine and clonidine as an adjuvant to the low volume local anaesthetic in ultrasound guided supraclavicular brachial plexus block hence a study was planned to compare the analgesic effect of clonidine with dexmedetomidine when given in low volume bupivacaine for ultrasound guided supraclavicular brachial plexus block.

sixtyASA 1 and ASA 2  patients were recruited according to computer generated random table into one of the three groups- clonidne,dexmedetomidine and control group. 20 cc of total drug was admnstered  under ultrasound guidance and the onset of the sensory and motor anaesthesia noted. the patients vitals were noted in form of VRS, heart rate, NIBP, sedation score, SpO2  every minute for the first ten minutes and then every ten minutes till the end of surgery. Post operatively allthese parameters were noted along with the regression of the motor and sensory blockade at 0 hour, 1 hr,2 hr,4 hr , 8 hr, 12 hr, 16 hr and 24 hr. The time of rescue analgesia in the form of injection diclofenac 75 mg was noted along with the total rescue needed in 24 hours. all the parameters were entered in excel sheet for statistical analysis.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-05-22
• Last Update Posted: 2015-05-28

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

sixty patients, belonging to ASA grade I and II undergoing open reduction and internal fixation for fracture of lower end arm and fractures of forearm bones.

Exclusion Criteria

•BMI >30 •Local infections •Anatomic deformities •Coagulation disorders •Allergy to local anesthetics,dexmedetomidine or clonidine.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.The onset, quality of anesthesia and duration of post operative analgesia	the outcomes are noted every minute after giving block for first 10 minutes and then every 5 minutes till the completion of the surgery. after surgery noted for 1hr, 2hr, 4hr, 8 hr, 12 hr, 18 hr, 24 hr.
2. Pain free period and rescue analgesic requirement	the outcomes are noted every minute after giving block for first 10 minutes and then every 5 minutes till the completion of the surgery. after surgery noted for 1hr, 2hr, 4hr, 8 hr, 12 hr, 18 hr, 24 hr.

Secondary Outcome Measures

Name	Time	Method
1.To record haemodynamic stability	2.time of block regression

Trial Locations

Locations (1)

Operation Room 1 and 2,2nd Floor,Clinical Block,Department of Anaesthesia rtment of Orthopaedics; 🇮🇳 Kangra, HIMACHAL PRADESH, India

Operation Room 1 and 2,2nd Floor,Clinical Block,Department of Anaesthesia rtment of Orthopaedics

🇮🇳Kangra, HIMACHAL PRADESH, India

Dr Usha Kumari

Principal investigator

9459301813

chaudhary.ushaarvind@gmail.com