Comparing two drugs potency seperately and in combination along with drug used for anesthetising in arm surgeries on providing pain relief during and after surgery

Not yet recruiting

• Conditions: Other Procedures, (2) ICD-10 Condition: 8||Other Procedures,

• Registration Number: CTRI/2021/07/035191
• Lead Sponsor: SRM Medical College Hospital and Research Centre

Brief Summary

Patients admitted in SRM Medical College Hospital & Research Centre posted for upper limb surgeries who fulfill the inclusion criteria will be enrolled in this study. Patients will be randomly allocated into three groups, Group DX, Group DM and Group DD, with 30 patients in each group based on computer generated random numbers.

The anesthesiologist performing the block and observing the patient will be blinded to the treatment group to avoid observer bias. Group DX will receive 20 ml of 0.5% Ropivacaine with 50 mcg Dexmedetomidine (0.5ml) and 1 ml normal saline, DM will receive 20 ml of 0.5% Ropivacaine with 4 mg Dexamethasone (1ml) and 0.5 ml normal saline and group DD will receive 20 ml of 0.5% Ropivacaine with 50 mcg of Dexmedetomidine (0.5ml) and 4mg of Dexamethasone (1ml). The total volume of the drug solution is made to 21.5 ml.

All patients will be premeditated with Tab.Alprazolam 0.5 mg PO 2 hrs before being shifted to the operating theatre. Patient’s vitals will be monitored with pulse oximetry, NIBP and ECG.

After taking proper aseptic precautions, under ultra sound guidance, Supraclavicular Brachial Plexus block will be given using 20 ml of 0.5% ropivacaine + 50 mcg dexmedetomidine (0. ml) and 1 ml normal saline in group DX, 20 ml of 0.5% ropivacaine + 4 mg dexamethasone (1ml) and 0.5 ml normal saline in group DM and group DD will receive 20 ml of 0.5% ropivacaine + 50 mcg of Dexmedetomidine (0.5ml) and 4mg of dexamethasone (1ml).

Sensory evaluation will be done by pin prick with a 25 G needle at an interval of  5, 10, 15, 20 and 30 minutes. The entire cutaneous innervation of upper limb i.e. musculocutaneous, radial, ulnar, median and medial cutaneous nerves of arm (MCNA) will be tested individually.

2 Normal sensation

1 Hypoesthesia

0 No sensation felt

A score of 0 will be taken as time of onset of sensory block for that nerve. Site of surgical incision and sparing of incision site will be noted

Motor block is assessed after 5, 10, 15, 20 and 30 minutes after injection of the drug as per Lavoie and colleagues:

0% - Flexion and extension in both the hand and arm against resistance

33% - Flexion and extension in both the hand and arm against gravity but not against resistance

66% - Flexion and extension movements in the hand but not in the arm

100% - No movement in the entire upper limb

Sedation score will be noted using Ramsay Scale

Level of Activity                                                                     Points

Patient anxious, agitated or restless                                           1

Patient co-operative, orientated and tranquil                              2

Patient responding only to verbal commands                             3

Patient with brisk response to light glabellar tap                        4

or loud auditory stimulus

Patient with sluggish response to light glabellar tap                   5

or loud auditory stimulus

Patient with no response to light glabellar or loud

auditory stimulus                                                                         6

The need for intra-operative supplementary systemic medication or general anaesthesia and adverse effects (namely vessel puncture, seizures, newly observed cardiac arrhythmias, oxygen saturation lower than 90%, signs of local anaesthetic toxicity, unintentional paresthesia) will be recorded. Failed blocks will be converted to general anaesthesia and will be excluded from the study. All patients will be post operatively monitored in the post anaesthesia care unit (PACU) for 24 hours and thereafter discharged to their wards.

Post-operative pain at the incision site will be  assessed by visual analogue pain scale (VAS), a score of more than 3 when recorded will be  taken as duration of post op analgesia and the patient will be  given supplementary analgesics i.e. Inj. Paracetamol 1000 mg (iv). If the patient elicits a VAS score of more than 6, Inj. Tramadol 100 mg (iv) will be administered as rescue analgesic.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-02-08
• Last Update Posted: 2021-07-17

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

Patients with ASA Physical Status I and II posted for upper limb surgeries under supraclavicular brachial plexus blocks Weighing between 50 – 100 kg.

Exclusion Criteria

All patients with ASA Physical Status III and above Patients who refuse to participate in the study Patients who are allergic to amide local anesthetics Patients who are pregnant Patients with chronic renal, cardiac or hepatic condition Patients with coagulation abnormalities.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Duration of analgesia	24 hours postoperatively

Secondary Outcome Measures

Name	Time	Method
1)Onset of sensory and motor block	2)Total amount of rescue analgesic used

Trial Locations

Locations (1)

SRM Medical College and Hospital; 🇮🇳 Kancheepuram, TAMIL NADU, India

SRM Medical College and Hospital

🇮🇳Kancheepuram, TAMIL NADU, India

Dr Annushha Gayathri G

Principal investigator

8939064666

annu.gayu@gmail.com