RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES,
BANGALORE, KARNATAKA
PROFORMA FOR REGISTRATION OF DISSERTATION
TOPIC
“COMPARATIVE STUDY OF INFLUENCE OF INTRATHECAL CLONIDINE AND FENTANYL ON POST-OPERATIVE ANALGESIC PROFILE OF SPINAL ROPIVACAINE IN AMBULATORY SURGERY”
RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES,
BANGALORE,KARNATAKA
ANNEXURE- II
PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION
1 / Name of the candidate and address(in block letters) / Dr.SREE LAKSHMI G DD/O DEVARAJU G N
#192/1,SRI NIDHI, BEHIND JALAHALLI POLICE STATION, JALAHALLI, BENGALURU-560013
2 / Name of the institution / ESIC-PGIMSR, ESIC MODEL HOSPITAL, RAJAJINAGAR,BENGALURU-560010
3 / Course of study and subject / MD ANAESTHESIOLOGY
4 / Date of admission to course /
06/06/2011
5 / Title of the topic /
“COMPARATIVE STUDY OF INFLUENCE OF INTRATHECAL CLONIDINE AND FENTANYL ON POST-OPERATIVE ANALGESIC PROFILE OF SPINAL ROPIVACAINE IN AMBULATORY SURGERY”
6
7 / BRIEF RESUME OF THE INTENDED WORK:
6.1 Need for the study:
There has been a tremendous rise in ambulatory surgical procedures necessitating fast-tracking anesthesia and rapid turn-over. The drawback of fast-tracking is inadequate post-operative analgesia following general anesthetic and residual block following spinal anesthetics.
In order to address this issue of post-operative analgesia without residual motor weakness or numbness, intrathecal adjuvants to small doses of spinal anesthetics are supplemented such as alpha agonists, opioids, neostigmine, ketamine, adenosine, epinephrine etc.(1)(2)
Further the arrival on the scene of Ropivacaine as local anesthetic which is known to produce less sensory and motor block than Bupivacaine(3) should theoretically be of clinical benefit, especially with above-mentioned adjuvants.
The present study is undertaken to evaluate relative efficacy and shortfalls of two such intrathecal adjuvants namely Fentanyl and Clonidine with Ropivacaine, on post-operative analgesic profile in Ambulatory surgery.
6.2 Review of literature :
Kock et al.(4) (2001), studied 120 patients of knee arthroplasty under spinal Ropivacaine 8mg alone and also spinal Ropivacaine 8mg with different doses of Clonidine (15 µg, 45 µg, 75 µg). Those on Ropivacaine only had short sensory and motor blockade (132±88 min and 110±35 min). Patients on 8 mg Ropivacaine and 75 µg Clonidine had longer sensory and motor blockade, high incidence of sedation and fall in arterial blood pressure. They concluded that Ropivacaine 8 mg and 15 µg Clonidine did not prolong sensory or motor blockade, afforded high quality of anesthesia and was not associated with detectable systemic effects.
McNamee et al(5) (2001), conducted a randomized study in 60 patients undergoing major orthopedic surgery with intrathecal injection of 3.5 ml of Ropivacaine (R) and Bupivacaine (B). Median time of onset of sensory block upto T10 with R group was 2 min(2-5 min) and B group 2 min(2-9 min). Duration of sensory block at T-10 was 3 hours for R group and 3.5hours for B group. Median duration of motor block was significantly shorter in the R group. They concluded that rapid recovery of sensory and motor blockade was seen with Ropivacaine.
Dobrydnjov et al(6) (2003), undertook a randomized double blinded study in 45 patients undergoing herniorrhaphy under 6mg Bupivacaine alone and 6 mg Bupivacaine with 15 µg or 30 µg of Clonidine. They found out that mean duration of motor blockade was significantly longer and VAS at rest and movement was significantly lower in patients who received Clonidine of 30µg.
Wong et al(7) (2004), have studied the effects of two different doses of isobaric Ropivacaine 0.75%. Group A received 3.5 ml and group B 4.5 ml of abovementioned drug. In group A time of onset of sensory block was 2.1 ± 9.6 min, maximum number of block segments was 18 ± 3.4, duration of sensory block at L3 251.2 ± 34.7 min and time for complete recovery from motor blockade was 264 ±52.1min. Same parameters with group B were 1.7 ± 7.3 min; 19.8 ± 3.7; 277 ± 51.1 min; 292 ± 64.5 min respectively.
Koltka et al(8) (2009), compared block characteristics of 52 patients undergoing abdominal surgery under spinal anaesthesia with 19.5mg Ropivacaine + 20 µg Fentanyl(group I) and 13 mg Bupivacaine+ 20 µg Fentanyl(group II). Level of sensory block was T7, duration of motor blocks 139 ± 39 min, intensity of complete motor block(Bromage scale 3) was 90 ± 25 min with group I. Same parameters in group II was T4 182 ± 46 min, 130 ± 40min respectively. They concluded that plain Ropivacaine 19.5 mg + 20 µg Fentanyl is associated with a lower level sensory block and shorter duration motor block.
Erturk et al(9) (2010), compared the block characteristics in 60 ASA II-III patients posted for hip arthroplasty with 12 mg Ropivacaine and 8 mg Bupivacaine with 20 µg Fentanyl added to both. They found that onset of sensory blockade with Ropivacaine-Fentanyl group was 3.17 ± 0.72 min which was longer than Bupivacaine-Fentanyl group 2.52 ± 0.69 min. 16 patients of Ropivacaine- Fentanyl group had motor block of Bromage scale 3 compared to 24 patients in other group. Fall in SBP, DBP. MBP, heart rate was to a greater degree in patients who received Bupivacaine-Fentanyl. They concluded that Ropivacaine caused less motor block and haemodynamic side effects.
6.3 Objectives of the study:
a) To find whether addition of Clonidine or Fentanyl to Ropivacaine intrathecally has any effect on intra and post-operative analgesia.
b) To find whether there is difference between Fentanyl and Clonidine regarding their effects on Ropivacaine block characteristics.
c) To look for any associated side effects
MATERIALS AND METHOD
7.1 Source of data
Patients posted for Ambulatory surgery such as hernioplasty, fissurectomy, haemorrhoidectomy, knee arthroscopy at ESIC Model Hospital, ESIC-PGIMSR, Rajajinagar, Bangalore-10.
Sample size: 40 patients with below-mentioned inclusion and exclusion criteria will be enrolled in each group.
Study design: A prospective randomized double blinded controlled study.
Inclusion criteria :
1. ASA grade 1 and 2
2. Age between 20 to 60 years
3. Patients undergoing Ambulatory surgery
4. Procedure lasting up to 2 hour
5. Patients with normal coagulation profile
6. Patient free from cardio-respiratory and autonomic dysfunction
Exclusion criteria ;
1. ASA grade 3 and 4 patients
2. Patients with contraindication for regional anesthesia (Eg: patient refusal,
coagulopathy, pre-existing neurological defect and cardiac disease)
3. Patients with known allergy to any drug.
4. Patients on antihypertensive and antidepressant drugs
5. Patients with morbid obesity
6. Emergency procedures
7.2 Method of study and collection of data
Informed consent will be obtained. Detailed pre-anesthetic evaluation will be done. Patients fulfilling the required criteria are randomized by sealed envelope method into three groups of 40 each-group R (only Ropivacaine), group RF (Ropivacaine and Fentanyl) and group RC(Ropivacaine and Clonidine). Patients and Anesthesiologist are blinded to study solution. The study solution will be prepared separately by a person not involved in the patient care .Control solution R contains 2 ml of 0.75% Ropivacaine made upto 2.5 ml with patient’s own CSF. RF solution contains 2 ml of 0.75% Ropivacaine and 0.5 cc of Clonidine(50µg/ml) and RC solution contains 2 ml of 0.75% Ropivacaine and 0.5 cc of Fentanyl(50 µg/ml) . Patients randomized to
each group will receive 2.5 ml of the control or study solution. Patients are draped and administered spinal anesthesia in sitting position at L4-L5 or L5-S1 interspace, with 25G Quincke’s needle using 2.5 ml of one of the above solutions, identity of which is not known to the observer. Patients are monitored with ECG, NIBP, SpO2 and respiration at regular intervals intra-operatively and continued the same for 2 hours . The assessment of sensory block, motor block and post-operative analgesia is made as shown under. Patients with inadequate spinal block, if any, are subjected to general anesthesia for intended surgery.
Parameters to be observed
a) Haemodynamic changes(pulse rate, SBP, DBP, MBP)
b) Respiratory rate and SpO2
c) Sensory block :
Time of Onset
Highest level of dermatome reached
Time for two segmental regression
Total duration of sensory loss
d) Motor block :
Time of onset
Magnitude of Bromage scale attained
Time taken for complete recovery(Bromage-0)
e) Assessment of analgesia
· Intra-operative :
Adequacy of analgesia
Need for supplemental analgesic or sedative
Drug and dose
· Post-operative :
Pain assessment by VAS
Time needed for first dose of parenteral analgesic
Duration of analgesia
f) Assessment of sedation as per Ramsay sedation scale
g) Adverse effect : nausea, vomiting, bradycardia, hypotension, desaturation, pruritis
h) Patient opinion : poor/good/excellent
Statistical analysis
Data will be expressed as either mean ±SD or number and percentages. Continuous variables (age, BMI, duration of surgery, duration of sensory and motor blockade) will be compared using ANOVA test. Categorical variables (gender, presence or absence of nausea, vomiting, hypotension, bradycardia, use of additional analgesic) chi-square test will be used. Level of significance used is p<0.05.
7.3 Does the study require any investigations or interventions to be conducted on patients or other humans or animals? If so please describe briefly.
NO
7.4 Has ethical clearance been obtained from your institution in case of 7.3?
YES
REFERENCES
1. Veering Bernabette. Focus on adjuvants in regional anesthesia. ESA 2005 May; 8RC4:217-221.
2. Miller D R, Eriksson I L, Fleisher A L, Wiener-Kronish P J, Young L W,
editors. Millers’ anesthesia. 17th ed. Published in United States of America: Churchill
Livingstone Elsevier; 2010. p.1624. (Spinal Anesthesia by David L. Brown; Section 4,
Chapter51, Volume2).
3. Stoelting K R , Hiller C S. Pharmacology and physiology in anesthetic practice.
4th ed. Philadelphia, United States of America: Lippincott Williams & Wilkins; 2006.p.200.
(Local Anesthetics; Section 1, Chapter 7)
4. Kock De., Philippe G, Fanard , Luc, Hody luc, Patricia L. Intrathecal Ropivacaine and Clonidine for Ambulatory knee arthroscopy: A dose – response study. Anaesthesiology 2001 April; 94(4): 574-8.
5. Mc Namee D A, Mc Clelland A M, Scott S , Milligan K R, Wastman L,Gustafsson U. Spinal anesthesia. Comparison of plain Ropivacaine 5 mg/ml with Bupivacaine5 mg/ml for major orthopedic surgery. Br J Anaesthesia 2002; 89: 702-6.
6. Dobrydnjov I , Axelsson, Thorn S E, Matthiesen, Klockhoff H, Holmstrom etal. Clonidine combined with small dose Bupivacaine during spinal anaesthesia for inguinal hernioplasty. Anesth Analg 2003; 96: 1496-503.
7. Wang J O, Tan T D, Leung P O,Tseng K F, Chru N W, tang C S. Comparison of the effects of two different doses of 0.75% glucose free Ropivacaine for spinal anesthesia for lower limb and lower abdominal surgery.Kaohsiug J Med Sci 2004 Sep; 20(9): 423-30.
8. Koltka K, Uludag E, Sentur M, Yavru A, Karadeniz M, Sengul T. etal. Comparison of equipotent doses of Ropivacaine-Fentanyl and Bupivacaine-Fentanyl in spinal anaesthesia for lower abdominal surgery. Anaesth Intensive Care 2009 Nov; 37(6): 923-8.
9. Erturk E, Tutuncu C, Eroglu A, Gokben M. Clinical comparison of 12mg Ropivacaine and 8mg Bupivacaine, both with 20µg Fentanyl in spinal anaesthesia for major Orthopedic surgery in Geriatric patients. Med Princ Pract 2010; 19(2): 142-7.
APPENDIX
Bromage scale:
Grade 0- Patient able to move at all the joints(Hip, Knee, Ankle)
Grade 1- Unable to move at hip joint
Grade 2- Unable to move at both hip and knee joint
Grade 3- Unable to move at all the 3 joint hip, knee and ankle
Ramsay sedation scale:
Score Responsiveness
1 Patient is anxious and agitated or restless or both
2 Patient is co-operative, oriented and tranquil
3 Patients responds to commands only
4 Patient exhibits brisk response to light glabellar or loud auditory stimulus
5 Patient exhibits a sluggish response to light glabellar tap or loud auditory stimulus
6 Patient exhibits no response.
SIGNATURE OF THE CANDIDATE:
REMARKS OF THE GUIDE : / THIS STUDY HAS FAR-REACHING IMPLICATIONS ON FAST–TRACK SURGERY AND IS LIKELY TO BOOST DAY-CARE SURGICAL OPERATIONS.
NAME AND DESIGNATION OF THE
GUIDE: / Dr. N. S. Kodandaram MD, DA.
Professor and HOD,
Department of Anaesthesiology,
Pain and Critical care
SIGNATURE OF THE
GUIDE:
HEAD OF THE DEPARTMENT: / Dr.N.S.Kodandaram MD, DA.
SIGNATURE OF THE HEAD OF THE DEPARTMENT:
REMARKS OF PRINCIPAL:
SIGNATURE
PROFORMA
Sl.No : Date of Surgery :
Name : IP No :
Age : Marital Status :
Sex : Occupation :
Address :
Diagnosis :
Surgery :
Weight :
Height : BMI :
ASA Status :
Informed Consent :
Group :
HISTORY
General Examination
Systemic Examination
Investigations:
Haemogram : ECG:
Coagulation profile : Chest X-ray:
Blood Sugar :
Blood Urea
Sr Creatinine:
Serum Electrolytes :
Blood Group:
PREOPERATIVE :
• Pulse :
• Blood Pressure :
• Resp Rate :
• SpO2 :
Preloading (vol in ml) :
Pre-medication given :
INTRAOPERATIVE RECORD
HAEMODYNAMIC VARIABLES :
MIN / 5 / 10 / 15 / 20 / 25 / 30 / 35 / 40 / 45 / 50 / 55 / 60 / 70 / 80 / 90 / 100 / 110 / 120HR
SBP
DBP
MBP
RESPIRATORY PARAMETERS
MIN / 5 / 10 / 15 / 20 / 25 / 30 / 35 / 40 / 45 / 50 / 55 / 60 / 70 / 80 / 90 / 100 / 110 / 120RR
SpO2
CHARACTERISTICS OF SENSORY BLOCK :
TIME OF ONSET :
HIGHEST LEVEL OF DERMATOME REACHED :
TIME FOR TWO SEGMENTAL REGRESSION :
TOTAL DURATION OF SENSORY LOSS :
CHARACTERISTICS OF MOTOR BLOCK :
TIME OF ONSET :
MAGNITUDE OF BROMAGE SCALE ATTAINED :
TIME TAKEN FOR COMPLETE RECOVERY (BROMAGE 0) :
ASSESSEMENT OF ANALGESIA
INTRA OPERATIVE :
ADEQUACY OF ANALGESIA : Adequate / Not Adequate.
NEED FOR SUPPLEMENTAL ANALGESIC OR SEDATIVE :
DRUG AND DOSE :
POST OPERATIVE :
PAIN ASSESSMENT BY VAS
TIME NEEDED FOR FIRST DOSE OF PARENTERAL ANALGESIA :
DURATION OF ANALGESIA
SEDATION SCORE :
MIN / 0 / 15 / 30 / 45 / 60 / 75 / 90 / 115 / 120SEDATION SCALE
ADVERSE EFFECTS :
1. NAUSEA
2. VOMITING.
3. BRADYCARDIA.
4. HYPOTENSION.
5. DESATURATION.
6. PRURITIS.
7. OTHERS.
PATIENT OPINION: POOR/GOOD/EXCELLENT.
CONSENT FORM
INFORMATION TO THE PARTICIPANT:
Anesthesia for lower abdominal surgeries is usually carried under Spinal Anesthesia by Local Anesthetics. Adjuvants are added to improve the quality, to accelerate the onset of action and to overcome the problems of spinal anesthesia.
We have undertaken a study to compare the merits & de-merits of Clonidine and Fentanyl added as adjuvants to Ropivacaine. We thus request your participation in the study. Anesthesia will be administered by a qualified Anesthesiologist (Principal / Co-Investigator).