RAJIV GANDHIUNIVERSITY OF HEALTH SCIENCES, KARNATAKA

BANGALORE

ANNEXURE – II

PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION

1 / NAME OF THE CANDIDATE AND ADDRESS ( IN BLOCK LETTERS) / : / DR.AHMEDI FATHIMA
DEPARTMENT OF ANAESTHESIOLOGY & critical care,
MAHADEVAPPA RAMPURE MEDICAL COLLEGE,
GULBARGA – 585105
PERMANENT ADDRESS / : / DR.AHMEDI FATHIMA
C/O MD.HASHIM
#115, 1ST CROSS,
DINNUR, R.T.NAGAR,
BANGALORE-560032
2 / NAME OF THE INSTITUTION / : / H.K.E. SOCIETY’S MAHADEVAPPA
RAMPURE MEDICAL COLLEGE,
GULBARGA – 585105
3 / COURSE OF STUDY AND SUBJECT / : / M.D. (ANAESTHESIOLOGY)
4 / DATE OF ADMISSION TO THE COURSE / : / 30TH MAY 2012
5 / TITLE OF TOPIC / : / “A COMPARATIVE STUDY OF ULTRASOUND GUIDED SUPRACLAVICULAR BRACHIAL PLEXUS BLOCK
USING BUPIVACAINE- LIGNOCAINE WITH ADRENALINE
AND
DEXMEDETOMIDINE ADDED TO BUPIVACAINE- LIGNOCAINE WITH ADRENALINE”
6 / Brief Resume of the Intended Work
6.1 / Need for the study
Supraclavicular brachial plexus block is a very popular mode of anaesthesia for various upper limb surgeries, due to its effectiveness in terms of cost and performance, margin of safety and good post operative analgesia1. Supraclavicular approach gives the most effective block for upper extremity and is carried out at the level of trunks of brachial plexus. The plexus is blocked where it is most compact i.e. at the middle of brachial plexus, resulting in homogenous spread of anaesthetic throughout the plexus with a fast onset and complete block.
A variety of adjuvants have been studied for brachial plexus blockade. Dexmedetomidine, a selective α2-adrenoceptor agonist, has been used as an adjuvant during regional and local anesthesia. Several studies have shown efficacy of adding dexmedetomidine to local anesthetic procedures, such as subarachnoid, epidural, and caudal injections. However, there remains limited knowledge on its analgesic efficacy and duration in peripheral nerve and nerve plexus blockade. Therefore, the need for this study to investigate the efficacy of dexmedetomidine as an adjuvant in combination with local anesthetics. The primary endpoints are the onset and duration of sensory and motor block and duration of analgesia.
6.2 / Review of Literature
Aliye esmaoglu et al1 evaluated the effect of adding dexmedetomidine(100µg) to 0.5% levobupivacaine for axillary brachial plexus blockade. The primary endpoints were the onset and duration of sensory and motor block and duration of analgesia. They concluded that dexmedetomidine added to levobupivacaine for axillary brachial plexus block shortens the onset time and prolongs the duration of the block and the duration of postoperative analgesia.
Obayah et al2 studied the effect of dexmedetomidine on the duration of sensory blockade. They evaluated the effect of adding 1µg/kg of dexmedetomidine to 0.25% bupivacaine on the duration of postoperative analgesia in children who underwent repair of a cleft palate.Conclusion of their study was, Greater palatine nerve block with a combination of dexmedetomidine and bupivacaine increased the duration of analgesia after repair of a cleft palate by 50% with no clinically relevant side effects.
Rachana Gandhi, Alka Shah and Ila Patel4 conducted a prospective double blind study to compare the postoperative analgesic efficacy and safety ofdexmedetomidine (30µg) for brachial plexus blockade along with bupivacaine (0.25%). Assessment of motorand sensory blockade, pulse, systolic blood pressure, respiration and side effects were noted every 5 minutes for first30 minute and every 10 minute till end of surgery. Duration of analgesia and incidence of various complicationsfollowing the procedure were observed.It was observed that in control group onset of motor and sensory blockade was faster. Whereas,dexmedetomidine group have better hemodynamic stability and greater postoperative analgesia.
Amany S. Ammar & Khaled M. Mahmoud5 conducted a prospective randomized controlled trial of ultrasound-guided infraclavicular brachial plexus block using 0.33%(30cc) bupivacaine alone or combined with 0.75µg/kg of dexmedetomidine, to study the efficacy of dexmedetomidine. The following brachial plexus nerve block parameters: block success rate, sensory onset time and duration, motor block onset time and duration, duration of analgesia, and amount of supplemental intravenous morphine required. They concluded that adding dexmedetomidine to bupivacaine provides enhancement of onset of sensory and motor blockade, prolonged duration of analgesia, increases duration of sensory and motor blockade, yields lower VRS pain scores and reduces supplemental opioid requirements.
Sarita S swamy et al6 compared clonidine and dexmedetomidine as an adjuvant to local anaesthetic agent in supraclavicular brachial plexus block with respect to onset and duration of sensory and motor block and duration of analgesia.Sixty ASA I and II patients scheduled for elective upper limb surgeries under supraclavicular brachial plexus block were divided into two equal groups in a randomized, double-blinded fashion. Group C received clonidine 1 μg/kg and Group D received dexmedetomidine 1 μg/kg added to bupivacaine 0.25% (35 cc). Onset and recovery time of sensory and motor block, duration of analgesia and quality of block were studied in both the groups. It was concluded that Dexmedetomidine when added to local anaesthetic in supraclavicular brachial plexus block enhanced the duration of sensory and motor block and also the duration of analgesia. The time for rescue analgesia was prolonged in patients receiving dexmedetomidine. It also enhanced the quality of block as compared with clonidine.
6.3 / Objectives of the study
To compare the effects of addition of Dexmedetomidine to Bupivacaine- Lignocaine with adrenaline combination for Supraclavicular brachial plexus block. The effects will be studied in terms of:
  • Onset of sensory blockade and motor blockade
  • Duration of sensory and motor blockade
  • Complications / side effects if any

7 / Materials and Methods
7.1 / Source of Data
Patients admitted to Basaveshwar Teaching and General Hospital, Gulbarga, attached to Mahadevappa Rampure Medical College.
7.2 / Methods of collection of data
Patients undergoing elective upper limb surgery will be included in the study, after obtaining the ethical committee clearance.
Inclusion criteria
Patients belonging to age group 18-60 years with ASA grade I and grade II undergoing elective operative procedure for upper limb surgeries (i.e. elbow, forearm and hand surgeries.)
Exclusion criteria
  1. Patients who refuse.
  2. Patients with history of bleeding disorders.
3.Patients with local infection at the site of block.
4.Patients with documented neuromuscular disorders.
5.Patients with respiratory compromise.
6.Patients with known allergy to local anaesthetic drugs.
7.ASA grade III and IV patients.
Mode of selection of cases :Random Sampling technique
Allocation to different regimens:
Group I: Patientsreceiving 0.5% bupivacaine (15ml)+ 2% lignocaine with adrenaline (15ml) + normal saline(0.5ml).
Group II:Patients receiving 0.5% bupivacaine (15ml)+2% lignocaine with adrenaline
(15ml) + Dexmedetomidine(0.5ml).
Sample size: 30 patients are taken as study and 30 patients are taken as control (total 60 patients).
Statistical data analysis: By using "t" tests and chi square tests data will be analysed.
Parameters of comparison:
60 patients will be randomly allotted into 2 groups, group I and group II. All the patients will receive injection Midazolam 0.05mg/kg and injection Fentanyl 0.5µg/kg intravenously 15 minutes before the procedure.
Supraclavicular brachial plexus block will be given with the patient lying supine with the head turned to opposite side. The probe of ultrasound machine will be placed over the supraclavicular region and brachial plexus will be identified. It will be approached using a 22G, 55mm needle. The onset and duration of sensory loss and motor blockade will be studied. The loss of pinprick sensation will be checked every 3 minutes till the onset of loss of sensation and then every ½ hourly till the regain of sensation. The motor blockade will be assessed every 3 minutes till the loss of movements and then every ½ hourly till the regain of movements.
Onset of action: Sensory & Motor blockade
Sensory block: The time interval between administration of local anesthetic solution to loss of pin prick sensation.
Motor block: The time interval between administration of local anesthetic solution to loss of movements.
Duration of blockade:
Sensory block: Time interval between loss of pin prick sensation to appearance of pin prick sensation.
Motor block: Time interval between loss of movements to appearance of the movements.
7.3 / Does the study require any investigation or intervention to be conducted on patients or other humans or animals? If so please describe briefly
Yes. The patients will undergo the investigations recommended by the ASA guidelines for the age prior to surgery
7.4 / Has ethical clearance been obtained from your institution in case of 7.3?
Yes.
8 / List of References
  1. Aliye Esmaoglu, Fusun Yegenoglu, MD, Aynur Akin, and Cemil Yildirim Turk: Dexmedetomidine Added to Levobupivacaine Prolongs Axillary Brachial Plexus Block. Anesth Analg-2010, Dec; 111(6):1548-51.
  2. Obayah, Gihan M; Refaie, Amira; Aboushanab, Ossama; Ibraheem, Neamat; Abdelazees, Mossad:Addition of dexmedetomidine to bupivacaine for greater palatine nerve block prolongs postoperative analgesia after cleft palate repair.European Journal of Anaesthesiology: March 2010; 27(3):280–284.
  3. Grewal A. Dexmedetomidine: New avenues. Journal of Anaesthesiology Clinical Pharmacology-2011, Sep, 19; 27:297-302.
  4. Rachana Gandhi, Alka Shah, Ila Patel: Use of Dexmedetomidine along with Bupivacaine for brachial plexus block. National journal of medical research:Jan-March 2012; 2(1):67-69.
  5. Amany S. Ammar, Khaled M. Mahmoud: Ultrasound-guided single injection infraclavicular brachial plexus block using bupivacaine alone or combined with dexmedetomidine for pain control in upper limb surgery: A prospective randomised controlled trial. Saudi Journal of Anaesthesia: April-june 2012;6(2):109-14 .
  6. Sarita S Swami, Varshali M Keniya, Sushma DLadi, Ruchika Rao: Comparison of dexmedetomidine and clonidine (α2 agonist drugs) as an adjuvant to local anaesthesia in supraclavicular brachial plexus block:A randomised double-blind prospective study.Indian Journal of Anaesthesia:2012 May-Jun;56(3): 243–249.

9 / Signature of candidate
10 / Remarks of Guide / This study is undertaken as per the rules and regulations of rguhs, Bangalore.
11 / 11.1 / Name and Designation of the Guide / Dr. KAJA SRIRAMAMURTHY
M.D
PROFESSOR,
DEPARTMENT OF ANAESTHESIOLOGYcritical care,
M.R. MEDICAL COLLEGE,
GULBARGA
11.2 / Signature
11.3 / Co- Guide (If Any)
11.4 / Signature
11.5 / Head of the Department / Dr. AWATI MAHADEV NURANDAPPA M.D,D.A
PROFESSOR AND HOD,
DEPARTMENT OF ANAESTHESIOLOGY & critical care,
M.R. MEDICAL COLLEGE,
GULBARGA
11.6 / Signature
12 / 12.1 / Remarks of the Chairman and Principal
12.2 / Signature