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My Thesis Protocol-4
My Thesis Protocol-4
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1.1 Introduction
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Dexmedetomidine has been extensively used as an adjuvant to LAs in central
neuraxial techniques and various peripheral nerve blocks. There are not many studies
evaluating the effect of Dexmedetomidine with Ropivacaine in TAP block for post-cesarean
analgesia. Hence, this study is undertaken to assess the efficacy of Dexmedetomidine with
Ropivacaine for TAP block as a part of multimodal analgesia in parturients undergoing
elective Lower Segment Cesarean Section (LSCS)
3. Baaj JM et al14 evaluated the efficacy of TAP block for post-cesarean analgesia. 40
patients undergoing cesarean section under spinal anesthesia were randomized to
receive bilateral ultrasound-guided TAP block with 20mL of either Bupivacaine 0.25%
or normal saline, at the end of surgery. Both the groups received patent-controlled
analgesia with IV Morphine. Total Morphine consumption in 24 hours was the primary
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outcome studied. It was reported that total Morphine consumption was reduced by 60%
in Bupivacaine group with improved satisfaction over 24 hours after surgery.
5. Belavy D et al16 evaluated the analgesic efficacy of US guided TAP block in patients
undergoing cesarean delivery. 50 women undergoing cesarean delivery, under spinal
anesthesia, were randomly divided into two groups receiving bilateral US guided TAP
block with either 0.5% Ropivacaine (n=25) or saline (n=25), at the end of surgery. All
patients received post-operative Paracetamol, NSAIDs, and patient controlled IV
Morphine. Each patient was assessed for 24 hour morphine usage, average pain score,
nausea, vomiting, pruritus, drowsiness, and satisfaction with pain relief. 24 hour
Morphine consumption was found to be reduced in patients who received TAP block
with Ropivacaine, with improved satisfaction with pain relief. They concluded that US-
guided TAP block reduces Morphine requirements after cesarean delivery when used
as a component of multimodal analgesia.
6. Singh R et al17 compared duration of post-operative analgesia with TAP block using
Bupivacaine alone versus Bupivacaine with Clonidine in patients undergoing LSCS
under spinal anesthesia. 100 patients were randomly divided to receive bilateral TAP
block by landmark technique with either 20 mL Bupivacaine 0.25% or 20mL
Bupivacaine with Clonidine 1mcg/kg after surgery. Patients were given rescue
analgesic with Diclofenac 1mg/kg IV on demand or if the VAS was ≥3. Total duration
of analgesia, total requirement of analgesics in first 24 hours, patient satisfaction and
side effects were studied. Duration of analgesia was significantly longer and mean
consumption of Diclofenac was reduced in patients who received TAP block with
Bupivacaine with Clonidine. They concluded that addition of Clonidine with
Bupivacaine n TAP block provides excellent post-operative analgesia upto 19 hours,
decreases post-operative analgesic requirement with minimal side-effects when
compared to Bupivacaine alone.
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hysterectomy under General Anesthesia. 60 patients were randomly divided into two
groups. At the end of surgery, group R (n=30) received bilateral TAP block with 20mL
Ropivacaine 0.3% and 2mL normal saline; whereas group RD (n=30) received 20mL
Ropivacaine 0.3% and Dexmedetomidine 0.5mcg/kg which was diluted to 2mL. VAS
pain scores, frequency of PCA pressed, Sufentanil consumption and post-operative
nausea and vomiting (PONV) were recorded. Compared with group R, the frequency
of PCA pressed and consumption of Sufentanil were significantly lower in group RD.
There was no significant difference between the two groups with respect to other
parameters studied. They concluded that US-guided TAP block could be an effective
component of multi-modal post-operative analgesia and adding Dexmedetomidine
potentiated the analgesic properties of Ropivacaine.
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Inclusion criteria:
1. ASA physical status II,
2. Patients weighing between 50 to 80kg,
3. Posted for elective LSCS, via Pfannenstiel incision, under spinal anesthesia with 0.5%
hyperbaric Bupivacaine.
Exclusion criteria:
1. Patient refusal
2. Contraindications to spinal anesthesia
3. Local infection at the site of block
4. Allergy to study medications
5. Coagulation disorders
6. Psychological disorders.
Methodology:
The recruited patients will be divided into two equal groups of 30 each to receive
either:
Group R (n=30): TAP block with 20mL of 0.375% Ropivacaine plus 2mL normal saline on
each side.
Group RD (n=30): TAP block with 20mL of 0.375% Ropivacaine plus 0.5mcg/kg of
Dexmedetomidine diluted to 2mL normal saline on each side.
A detailed pre-anesthetic evaluation will be done on the day before surgery.
Informed consent will be obtained from all the parturients. Parturients will be explained about
VAS scores, 0 being no pain and 10 being the worst imaginable pain, and pre-operative nil
per oral status. On the day of surgery, all the parturients will be preloaded with 10mL/kg of
Ringer’s Lactate and premedicated with Inj. Rantidine 50mg IV and Inj. Metoclopramide
10mg IV 30 minutes prior to surgery. After shifting to operating table multiparameter monitors
(GE B20) will be connected and basal heart rate, blood pressure and peripheral oxygen
saturation will be recorded. Under aseptic precautions, parturients will receive spinal
anesthesia with 1.8mL of 0.5% hyperbaric Bupivacaine with 25 microgram of Fentanyl.
At the end of surgery, all parturients will receive bilateral US guided TAP block.
Parturients will be randomly allocated to two groups.
Group R (n=30): 20mL of 0.375% Ropivacaine plus 2mL normal saline on each side.
Group RD (n=30): 20mL of 0.375% Ropivacaine plus 0.5mcg/kg of Dexmedetomidine diluted
to 2mL normal saline on each side.
Randomization will be performed using computer generated random number. The
number will be concealed and sealed in opaque envelopes, which will be opened prior to the
performance of block. The study drug will be prepared by an assistant not involved in the
study. The patient and anesthesiologist performing and collecting the data will be blinded to
the study drug.
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After skin preparation, TAP block will be administered using ultrasound guidance
(SonoSite Edge). A high frequency (6–13MHz) US linear probe will be placed transverse to
abdominal wall in mid-axillary line, midway between costal margin and iliac crest, in the
triangle of Petit. After visualizing three muscular planes (External Oblique, Internal Oblique
and Transverse Abdominis muscles), the needle will be introduced by in-plane approach and
advanced until it reaches the plane between Internal Oblique and Transverse Abdominis
muscles. Study drug will be injected after negative aspiration for blood and the spread of drug
in the plane will be observed. The same procedure will be repeated on the other side. Time of
completion of block procedure will be considered as time zero. All parturients will receive
Paracetamol 1g IV infusion and Diclofenac suppository 100mg.
In the post-operative period, parturients will be assessed for pain by VAS score at
2, 4, 6, 8, 12, 18 and 24 hours. Rescue analgesia will be given on demand or if VAS score ≥
4, in the form of Tramadol 2mg/kg IV. Time for first request of analgesia and total Tramadol
consumption in the first 24 hours will be recorded. Sedation scores will be evaluated using
Ramsay sedation scale as follows
1. Anxious and agitated or restless, or both
2. Co-operative, oriented and tranquil
3. Responds to command only
4. Exhibits brisk response to light glabellar tap or loud auditory stimulus
5. Exhibits sluggish response to light glabellar tap or loud auditory stimulus
6. No response to light glabellar tap or loud auditory stimulus
Patient satisfaction with pain management will be assessed by a four point score20.
1. extremely satisfied
2. satisfied
3. dissatisfied
4. extremely dissatisfied
Patients will be observed for other associated side-effects like dry mouth, nausea, vomiting,
hypotension (< 20% of baseline), and bradycardia (< 60 bpm).
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1.5 References
1. IIPS and Macro International (2007): National Family Health Survey (NFHS-3), 2005-2006,
India, Vol. I and Vol. II, International Institute for Population Sciences, Mumbai.
2. Leung AY. Postoperative pain management in obstetric anaesthesia – new challenges and
solutions. J Clin Anaesth. 2004;16(1):57–65
3. Gadsden J, Hart S, Santos AC. Post-cesarean delivery analgesia. Anesth Analg.
2005;101:S62–9. doi: 10.1213/01.ANE.0000177100.08599;.C8
4. Tan TT, Teoh WH, Woo DC, Ocampo CE, Shah MK, Sia AT. A randomised trial of the
analgesic efficacy of ultrasound-guided transversus abdominis plane block after caesarean
delivery under general anaesthesia. Eur J Anaesthesiol. 2012;29:88–94
5. Baka NE, et al. Colostrum morphine concentrations during postcesarean intravenous patient-
controlled analgesia. Anesth Analg. 2002;94(1):184–7
6. Sujata N, Hanjoora VM (2014) Pain Control After Cesarean Birth – What are the Options?. J
Gen Pract 2:164. doi:10.4172/2329-9126.1000164
7. Christie IW, McCabe S. Major complications of epidural analgesia after surgery: results of a
six-year survey. Anaesthesia. 2007;62(4):335–41. Epub 2007/03/27. doi: 10.1111/j.1365-
2044.2007.04992.x .
8. Horlocker TT, Kopp SL, Wedel DJ. Peripheral nerve blocks. Chapter 57. In: Miller’s
Anaesthesia. 8th ed. Philadelphia:Elsevier Saunders;2015. pp.1735
9. Barrington MJ, Ivanusic JJ, Rozen WM, Hebbard P. Spread of injectate after ultrasound-
guided subcostal transversus abdominis plane block: a cadaveric study. Anaesthesia.
2009;64(7):745–750.
10. K Knudsen, M Beckman Suurküla, S Blomberg, J Sjövall, N Edvardsson; Central nervous
and cardiovascular effects of i.v. infusions of ropivacaine, bupivacaine and placebo in
volunteers.. Br J Anaesth 1997; 78 (5): 507-514. doi: 10.1093/bja/78.5.507
11. Yoshitomi T., Kohjitani A., Maeda S., Higuchi H., Shimada M., Miyawaki T.
Dexmedetomidine enhances the local anesthetic action of lidocaine via an α-2a adrenoceptor.
Anesthesia and Analgesia. 2008;107(1):96–101. doi: 10.1213/ane.0b013e318176be73.
12. Mankikar MG, Sardesai SP, Ghodki PS, Ultrasound-guided transversus abdominis plane
block for post-operative analgesia in patients undergoing cesarean section. Indian J Anaesth
2016;60:253-7.
13. Srivastava U, Verma S, Singh TK, Gupta A, Saxsena A, JagarKD et al. Efficacy of trans
abdominis plane block for post cesarean delivery analgesia: A double blind, randomized trial.
Saudi J Anaesth 2015;9:298-302
14. Baaj JM, Alsatli RA, Majaj HA, Babay ZA, Thallaj AK. Efficacy of ultrasound-guided
transversus abdominis plane (TAP) block for postcesarean section delivery analgesia--a
double-blind, placebo-controlled, randomized study. Middle East J Anesthesiol.
2010;20:821–6
15. McDonnell JG, Curley G, Carney J, Benton A, Costello J, Maharaj CH, et al. The analgesic
efficacy of transversus abdominis plane block after cesarean delivery: A randomized
controlled trial. Anesth Analg. 2008;106:186–91
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16. Belavy D, Cowlishaw PJ, Howes M, Phillips F. Ultrasound-guided transversus abdominis
plane block for analgesia after caesarean delivery. Br J Anaesth 2009;103:726-30.
doi:10.1093/bja/aep235
17. Singh R, Kumar N, Jain A, Joy S. Addition of clonidine to bupivacaine in transversus
abdominis plane block prolongs postoperative analgesia after cesarean section. J
Anaesthesiol Clin Pharmacol 2016;32:501-4
18. Luan H, Zhang X, Feng J, Zhu P, Li J, Zhao Z. Effect of dexmedetomidine added to
ropivacaine on ultrasound-guided transversus abdominis plane block for postoperative
analgesia after abdominal hysterectomy surgery: a prospective randomized controlled trial.
Minerva Anestesiol 2016;82:981-8.
19. Venkatraman R, Abhinaya RJ, Sakthivel A, Sivarajan G. Efficacy of ultrasound-guided
transversus abdominis plane block for postoperative analgesia in patients undergoing
inguinal hernia repair. Local and Regional Anesthesia. 2016;9:7-12.
doi:10.2147/LRA.S93673.
20. Mishra M, Mishra SP, Singh SP. Ultrasound-guided transversus abdominis plane block:
What are the benefits of adding dexmedetomidine to ropivacaine? Saudi Journal of
Anaesthesia. 2017;11(1):58-61. doi:10.4103/1658-354X.197348.
21. Rai P, Singh D, Singh SK, Malviya D, Bagwans MC. Effect of addition of dexmedetomidine
to ropivacaine in transversus abdominis plane block on postoperative pain in lower segment
caesarean section: A randomized controlled trial. J Dent Med Sci. 2016;15:122–5.
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1.5 STUDY PROFORMA
Address: Diagnosis:
Pre-anesthetic Evaluation
Significant history:
Comorbidities:
Known allergies:
Airway Examination:
Systemic Examination:
CVS: P/A:
RS: CNS:
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Investigations: ASA Physical Status:
Premedication:
Technique:
Spinal anesthesia:
TAP block:
VAS scores:
VAS
SCORE
TIME 1 2 3 4 5 6 7 8 9 10
(HOURS)
12
18
24
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Ramsay sedation scale:
SEDATION
SCALE
1 2 3 4 5 6
TIME
(HOURS)
12
18
24
Patient satisfaction:
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INFORMED CONSENT FORM
Name of the principal investigator: Dr. Rio Rocky Tel. No. + 91 7760585534
I have received the information sheet on the above study and have read and / or understood
the written information.
I have been given the chance to discuss the study and ask questions.
I consent to take part in the study and I am aware that my participation is voluntary.
I understand that I may withdraw at any time without this affecting my future care.
I understand that the information collected about me from my participation in this research
and sections of any of my medical notes may be looked at by responsible persons (ethics
committee members/regulatory authorities). I give access to these individuals to have access
to my records.
I understand I will receive a copy of the patient information sheet and the informed consent
form.
Signature/Thumb
Impression
Date
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APPROVAL OF SCIENTIFIC COMMITTEE AND ITS COMPOSITION
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