Rajiv Gandhi University of Health Science s3

RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCE

KARNATAKA, BANGALORE

PROFORMA

FOR REGISTRATION OF SUBJECT FOR DISSERTATION

TOPIC:

“A PROSPECTIVE OBSERVATIONAL STUDY ON TRAVSVERSUS ABDOMINIS PLANE (TAP) BLOCK USING ‘DOUBLE-POP’ TECHNIQUE FOR POSTOPERATIVE ANALGESIA FOLLOWING CESAREAN SECTION.”

Dr. ALEN MATHEW,

POST GRADUATE STUDENT

DEPARTMENT OF ANAESTHESIOLOGY

K V G MEDICAL COLLEGE AND HOSPITAL

SULLIA.D.K

RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES

KARNATAKA

BANGALORE

ANNEXURE-II

PRO FORMA FOR REGISTRATION OF SUBJECT FOR DISSERTATION

1. / NAME OF CANDIDATE AND ADDRESS
(IN BLOCK LETTERS) / Dr. ALEN MATHEW
POST GRADUATE STUDENT
DEPARTMENT OF ANAESTHESIOLOGY
K V G MEDICAL COLLEGE AND HOSPITAL
SULLIA.D.K
2. / NAME OF THE INSTITUTION / K.V.G MEDICAL college AND HOSPITAL, KURUNJIBAG, SULLIA-574327, karnataka
3. / COURSE OF STUDY AND SUBJECT / M.D. IN ANAESTHESIOLOGY
4. / DATE OF ADMISSION TO COURSE / 31-07-2013
5. / TITLE OF THE TOPIC / “A PROSPECTIVE OBSERVATIONAL STUDY ON TRAVSVERSUS ABDOMINIS PLANE (TAP) BLOCK USING ‘DOUBLE-POP’ TECHNIQUE FOR POSTOPERATIVE ANALGESIA FOLLOWING CESAREAN SECTION.”
6. / BRIEF RESUME OF THE INTENDED WORK
6.1 NEED FOR THE STUDY :
Thoraco-lumbar nerve blocks have been used in anaesthesia since the 19th century. Techniques described included the rectus sheath block, ilio-inguinal block and abdominal field blocks. The transversus abdominis plane (TAP) block is an effective method of providing postoperative analgesia in patients undergoing midline abdominal wall incisions.1 It is being used for postoperative analgesia for upper and lower abdominal surgeries. Local anaesthetic is deposited in the neuro-fascial plane between the internal oblique and the transversus abdominis muscle. This technique provides analgesia to the parietal peritoneum as well as the skin and muscles of the anterior abdominal wall.2
Ultrasound guidance is increasingly being used for regional anaesthesia and several modified approaches to the TAP block using ultrasound guidance have been described. These include a subcostal approach and an anterior approach at the mid-point of the 12th rib and iliac crest in the mid-axillary line.
Landmark TAP block has a better validation compared to ultrasound guided TAP block in terms of randomized controlled trials. The technique has been shown by the originators, McDonnell and colleagues, to supplement multi-modal analgesia in midline incision colonic surgery, abdominal hysterectomy, caesarean section and appendicectomy.3,4,1,5 The technique as published has only recently been validated by an independent group in caesarean section although two studies of landmark TAP blocks placed by the surgeon from the inside in to the triangle of Petit area showed benefit in abdominoplasty and colorectal surgery.678 In one study in 2011 by McMorrow landmark TAP block tested with and without intra-thecal morphine did not improve analgesia after caesarean section but the study was poorly powered for multiple comparisons with only 20 patients in each of 4 groups.9
There have been case reports of complications attributed to TAP blocks such as liver punctures.10 At the same time, studies have also shown that even intraperitoneal injection of local anesthetics can reduce pain in the post operative period.11The primary need for this study is to evaluate the need for requirement of further postoperative analgesics and thereby ensure the efficacy of this procedure which would provide a cost-effective and economical measure for analgesia even in a rural set up. We must also accept the fact that the concept of ultrasound-guided TAP block not only requires immense skill and expertise but also that it is expensive in its own way due to the need for more sophisticated tools.
6.2 REVIEW OF LITERATURE :
Transversus abdominis plane block is safe, reduces postoperative analgesia requirements, nausea and vomiting and even the severity of pain after abdominal surgery. It should be considered as part of a multimodal approach to anaesthesia and enhanced recovery in patients undergoing abdominal surgery.12
The aim of a TAP block is to block the sensory afferent nerves supplying the anterior abdominal wall. These nerves pass through the neural plane between the internal oblique and transversus abdominis muscles.13 There are two approaches to blocking the nerves in this plane and these are the blind ‘double-pop’ technique or using ultrasound to locate the fascial planes. TAP blocks have been shown to reduce postoperative opioid requirements and increase patient comfort.1,3,14
Initially described by Rafi and McDonnell et al, the traditional TAPB method, where a blunt needle was blindly inserted vertically in the 'Triangle of Petit' (marked by the iliac crest, external abdominal oblique muscle, and latissimus dorsi muscle), and after feeling a 'pop' when the fascia was punctured, local anesthetics were infused and no complications attributable to this method of TAP block were reported.2,15 The technique, as originally described, entails multiple injections and administration of potentially toxic doses of local anaesthetic agent.16 The new approach, however involves identifying the neurovascular plane of the abdominal musculature and injecting a local anaesthetic agent therein.
This landmark-based ‘double-pop’ technique via the lumbar triangle of Petit, which accesses the nerves as they course through the fascial plane between the internal oblique and transverses abdominis muscles, was described, and has been shown to be an effective analgesic adjunct for lower abdominal surgery.1,4,17 Sometimes the relevant nerves to be blocked may not all be at the point of the lumbar triangle of Petit but will be present invariably at the midaxillary line.18
McDonnell in 2007 reported in 3 volunteers that the cutaneous extent of block from 20ml 0.5% lidocaine from bilateral landmark TAP through the palpated triangle of Petit was T7 to L1 anteriorly; the lateral spread was not reported.13Radiological spread of contrast in this study was mainly anterior in the TAP with some spread into more superficial layers. The needle insertion site from the imaging seemed to be more lateral than postero-lateral and several cm anterior to the suggested target which was the triangle of Petit.
Eventhough no subsequent clinical studies have assessed the clinical spread of landmark TAP however Carney in 2011, part of the same group measured the cutaneous block again in volunteers using 0.3ml/kg and 0.6ml/kg of 0.125% levo bupivacaine and Magnevist.19 The block was predominately found in the distribution of the lateral branches of the segmental nerves extending between the lower ribs and upper thigh however there was considerable variation and no clear relationship to volume. Carney et al had also made a comparison of 4 injection sites, namely, ultrasound guided subcostal injection, ultrasound guided mid axillary line injection above the iliac crest, ultrasound guided injection posterior to the transversus muscle (deep to the anatomical position of the triangle of Petit) and also the landmark approach through the triangle of Petit, this time marked more accurately on the skin.19
Future research is also needed to establish the optimal volume and concentration of local anaesthetic and whether the use of adjuvants is beneficial. In view of its limited motor supply the abdominal wall may be the ideal location for ultra-long acting local anaesthetics or slow release systems. Studies highlight the need to match the block technique to the surgery in terms of the anatomical nerve course and we don’t know at present whether the paravertebral spread from injection via the triangle of Petit leads to better analgesia compared to anteriorly distributing injections. Other questions that need to be answered include the effectiveness of single shot compared to continuous techniques and when is the optimal timing to perform the block in relation to the surgery.
6.3  OBJECTIVE OF STUDY :
Primary Objective
To evaluate the efficacy of performing TAP block using ‘double pop’ technique for postoperative analgesia following Cesarean section.
7 / MATERIALS AND METHODS :
7.1 SOURCE OF DATA :
The study will be conducted on patients aged between 18 to 40 years undergoing elective Cesarean section at K.V.G Medical College and Hospital, Sullia from December 2013 to March 2015.
Sample size: 100
Sampling method: Random sampling
Study design: Prospective clinical study
Statistical Analysis: Proportions, percentages, t-test and other appropriate non-parametric statistical tests will be done.
7.2  METHOD OF COLLECTION OF DATA :
One hundred patients, belonging to American Society of Anesthesiologists physical status grade I or II, aged between 18 to 40 years, undergoing elective Cesarean section will be randomly selected. Informed written consent will be taken. Result values will be recorded using a preset pro forma.
Inclusion criteria
·  Age group of 18-40 years.
·  ASA grade I or II.
·  Patients coming for elective cesarean section
Exclusion criteria
·  ASA grade III and IV.
·  Patient refusal.
·  Coagulopathy or anti-coagulation treatment (INR>1.5)
·  Infection at the site of injection.
·  Patients with chronic pain syndrome
·  Patients who received any NSAIDs or opiates 48 hours prior to surgery.
·  Preoperative chronic dependence on opioid medication.
·  History of allergy to the study drug
·  Body Mass Index (BMI) 18 or >35 Kg/m2
·  Alcohol or drug abuse.
Procedure:
All patients will undergo preanaesthetic evaluation on the previous day of surgery. Basic lab investigations like Hb, FBS or RBS, blood urea, serum creatinine and ECG will be carried out routinely in all patients. The entire procedure will be explained to the patient.
Drug and equipments necessary for resuscitation will be kept ready. An i.v line will be secured and routine monitors (ECG, NIBP, pulse oximetry) will be applied in the operating room. Baseline readings will be recorded. All patients will receive Inj Ondansetron 4mg IV and Inj Rantac 150mg IV 30 minutes before the procedure.
Before performing spinal anesthesia, each patient is preloaded with 10 ml/kg of lactated Ringer’s solution. Following the guidelines for asepsis and antisepsis, subarachnoid anesthesia will be instituted at either the L3-4 or L4-5 interspaces. A volume of 2-2.5 ml of hyperbaric bupivacaine will be injected using a 23 G Quincke Babcock spinal needle.
The women undergoing elective cesarean section will be randomized to undergo either TAP block with 10 ml of 0.2% ropivacaine (n-50) on each side, which will be classified as Group A versus 10 ml of saline (n-50) on each side which will be Group B. All patients will also receive rectal diclofenac 1 mg/kg to a maximum of 100 mg at the end of surgery.
The TAP block is performed at the end of the surgery using the blind ‘double pop’ or loss-of-resistance technique. Firstly, an 18 G needle is used to negate the cushion effect of the subcutaneous tissue. Then, a 23-gauge, Quincke Babcock blunted spinal anesthesia needle is attached to a syringe filled with the study solution. This loss-of resistance method can be easily employed as the fascial extensions of the abdominal wall muscles within the floor of the triangle of Petit create an easily appreciated increased resistance to needle advancement. With the patient in supine position and the investigator standing on the same side, the iliac crest is first palpated from anterior to posterior until the latissimus dorsi muscle insertion is felt. The triangle of Petit can be palpated between the anterior border of latissimus dorsi, the posterior border of the external oblique, and the iliac crest. The skin over the triangle of Petit is then pierced with the needle held at right angles to the coronal plane. The needle is stabilized and advanced at right angles to the skin in a coronal plane until resistance is felt. This first resistance shows that the needle tip was traversing the fascial extension of the external oblique muscle. Further gentle advancement of the needle resulted in a loss of resistance, or “pop” sensation, as the needle entered the plane between the external and internal oblique fascial layers. Still further gentle advancement results in the appreciation of a second increased resistance as the needle traversed the fascial extension of internal oblique. A second pop indicates entry into the transverses abdominis fascial plane. After careful aspiration to exclude vascular puncture, 10 ml of 0.2% Ropivicaine or 10 ml of saline is injected observing closely for signs of toxicity. If there is any resistance to this injection then this clearly indicates that the needle is not between the fascial planes, and thereby requiring repositioning of the needle. The TAP block is then performed on the opposite side using the same technique.
The presence and severity of pain, sedation and nausea is then assessed systematically. Visual Analog Scores (VAS) (ie. 0 =no pain, 5 =worst imaginable) for pain will be assessed serially at 30 min, 60 min, 2hrs, 6 hrs, 12 hours and 24 hours after surgery. Rescue analgesics will be administered if VAS ≥ 4. The time for first analgesic request will be recorded. Number of patients requiring rescue analgesics in the first 24 hours postoperatively will be recorded. The total dose of rescue analgesics required in the first 24 hours will also be recorded. Occurrence of any complications (hematoma, bleeding, infection, pneumoperitoneum) will be assessed.
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.
Yes. The patients will undergo the investigations recommended by the ASA guidelines for the age and co-morbid illnesses, if any.
Investigations:
Urine : Albumin, Sugar, microscopy
Blood : Hb, TC, DC, ESR
BT, CT
HBsAg, HIV
Blood urea, Serum Creatinine.
ECG
Follow up: Yes.
Follow up period: 24 hours
7.3  Has the ethical clearance been obtained from your institution?
Yes. Ethical committee clearance copy is enclosed.
8. LIST OF REFERENCES:
1. McDonnell JG, Curley G, Carney J et al. The analgesic efficacy of transversus abdominis plane block after cesarean delivery: a randomized controlled trial. Anesth Analg Jan 2008; 106(1): 186-91
2. Rafi AN. Abdominal field block: a new approach via the lumbar triangle. Anaesthesia Oct 2001; 56(10): 1024-6
3. McDonnell JG, O'Donnell B, Curley G, Heffernan A, Power C, and Laffey JG. The analgesic efficacy of transversus abdominis plane block after abdominal surgery: a prospective randomized controlled trial. Anesthesia and Analgesia Jan 2007; 104(1): 193–197
4. Carney J, McDonnell JG, Ochana A, Bhinder R, Laffey JG. The transversus abdominis plane block provides effective post-operative analgesia in patients undergoing total abdominal hysterectomy. Anesth Analg Dec 2008; 107(6): 2056-60
5. Carney J, Finnerty O, Rauf J, Curley G, McDonnell JG, Laffey JG. Ipsilateral transversus abdominis plane block provides effective analgesia after appendectomy in children: a randomized controlled trial. Anesth Analg Oct 2010; 111(4): 998-1003
6. Eslamian L, Jalili Z, Jamal A, Marsoosi V, Movafegh A. Transversus abdominis plane block reduces postoperative pain intensity and analgesic consumption in elective cesarean delivery under general anesthesia. J Anesth June 2012; 26(3): 334-8
7. Sforza M, Andjelkov K, Zaccheddu R, Nagi H, Colic M. Transversus abdominis plane block anesthesia in abdominoplasties. Plast Reconstr Surg Aug 2011; 128(2): 529-35
8. Bharti N, Kumar P, Bala I, Gupta V. The efficacy of a novel approach to transversus abdominis plane block for postoperative analgesia after colorectal surgery. Anesth Analg Jun 2011; 112(6): 1504-1508
9. McMorrow RC, Ni Mhuircheartaigh RJ, Ahmed KA, Aslani A, Ng SC, Conrick-Martin I, Dowling JJ, Gaffney A, Loughrey JP, McCaul CL. Comparison of transversus abdominis plane block vs spinal morphine for pain relief after Caesarean section. Br J Anaesth May 2011; 106(5): 706-12
10. Farooq M, Carey M. A case of liver trauma with a blunt regional anaesthesia needle while performing transversus abdominis plane block. Reg Anesth Pain Med May 2008; 33(3): 274-5
11. Boddy AP, Mehta S, Rhodes M. The effect of intraperitoneal local anesthesia in laparoscopic cholecystectomy: a systematic review and meta-analysis. Anesth Analg Sep 2006; 103(3): 682-8
12. Johns N, O'Neill S, Ventham NT, Barron F, Brady RR, Daniel T. Clinical effectiveness of transversus abdominis plane (TAP) block in abdominal surgery: a systematic review and meta-analysis. Colorectal Dis Oct 2012; 14(10): 635-42
13. McDonnell J, O’Donnell B, Farrell T, Gough N, Tuite D, Power C, Laffey J. Transversus Abdominis Plane Block: A Cadaveric and Radiological Evaluation. Regional Anesthesia and Pain Medicine Sep 2007; 32(5): 399-404
14. Hebbard P, Royse C. Audit of transverse abdominis plane block for analgesia following caesarean section. Anesthesia Dec 2008; 63(12): 1382
15. McDonnell JG, O’ Donnell BD, Tuite D, et al. The regional abdominal field infiltration (R.A.F.I.) technique: computerized tomographic and anatomical identification of a novel approach to the transversus abdominis neuro-vascular fascial plane. Anesthesiology
2004; 101: A899
16. Atkinson RS, Rushman GB, Lee JA. A Synopsis of Anaesthesia.10th edn, Bristol, Wright, 1987; 637-40
17. O'Donnell BD, McDonnell JG, and McShane AJ. The Transversus Abdominis Plane (TAP) block in open retropubic prostatectomy. Regional Anesthesia and Pain Medicine Jan 2006; 31(1): 91
18. Z. B. Jankovic, F. M. du Feu, and P. McConnell. An anatomical study of the transversus abdominis plane block: location of the lumbar triangle of petit and adjacent nerves Anesthesia and Analg Sep 2009; 109(3): 981–985
19. Carney J, Finnerty O, Rauf J, Bergin D, Laffey JG, Mc Donnell JG. Studies on the spread of local anaesthetic solution in transversus abdominis plane blocks. Anaesthesia Nov 2011; 66(11): 1023-30
SIGNATURE OF THE CANDIDATE / (Dr. ALEN MATHEW)
10. / REMARKS OF THE GUIDE / TAP block using “double - pop” technique is one of the newer methods for post operative analgesia in cesarean section. In this study we will evaluate the efficacy and cost effectiveness of the procedure even in a rural setup where ultrasound guidance is not available for performing TAP block
11. / NAME AND DESIGNATION OF
11.1 GUIDE / Dr. SHANKARANARAYANA. P
ASSOCIATE PROFESSOR
DEPARTMENT OF ANESTHESIOLOGY
K.V.G MEDICAL COLLEGE & HOSPITAL, SULLIA
11.2 SIGNATURE
11.5 HEAD OF THE DEPARTMENT / Dr. GANAPATI. P
PROFESSOR & H.O.D OF ANESTHESIOLOGY
K.V.G MEDICAL COLLEGE & HOSPITAL, SULLIA
11.6 SIGNATURE
12 / 12.1 REMARKS OF THE PRINCIPAL
12.2 SIGNATURE

INSTITUTIONAL ETHICAL COMMITTEE CLEARANCE