FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2018/11/016455 [Registered on: 28/11/2018] Trial Registered Prospectively
Last Modified On: 03/12/2018
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Abdominal surgeries and postoperative pain relief 
Scientific Title of Study   COMPARISON OF ANALGESIC EFFICACY OF PERINEURAL VERSUS SYSTEMIC DEXAMETHASONE AS AN ADJUVENT WITH LEVOBUPIVACAINE IN ULTRASOUND GUIDED BILATERAL RECTUS SHEATH BLOCK FOR PATIENTS UNDERGOING ABDOMINAL SURGERIES WITH MIDLINE INCISION: A PROSPECTIVE RANDOMIZED CONTROL TRIAL  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Geeta Singariya 
Designation  Professor 
Affiliation  Dr. S.N. medical collage, Jodhpur 
Address  123 Vaishali avaenue Opposite B R Birla Public School, Jhawar road Jodhpur
Dr. S.N. medical collage, Jodhpur
Jodhpur
RAJASTHAN
342008
India 
Phone  09414803554  
Fax    
Email  geetamanojkamal@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Geeta Singariya 
Designation  Professor 
Affiliation  Dr. S.N. medical collage, Jodhpur 
Address  123 Vaishali avaenue Opposite B R Birla Public School, Jhawar road Jodhpur
Dr. S.N. medical collage, Jodhpur
Jodhpur
RAJASTHAN
342008
India 
Phone  09414803554  
Fax    
Email  geetamanojkamal@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Pradeep kumar Saini 
Designation  Postgraduate student  
Affiliation  Dr. S.N. medical collage, Jodhpur 
Address  Dr. S.N. medical collage, Jodhpur

Jodhpur
RAJASTHAN
342001
India 
Phone  09530276208  
Fax    
Email  pradeep.nkt@gmail.com  
 
Source of Monetary or Material Support  
Dr S N Medical College, Jodhpur 
 
Primary Sponsor  
Name  Dr S N Medical College and attached Hospital Jodhpur 
Address  Shastri nagar Jodhpur Rajasthan 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DrGeeta Singariya  Mathura Das Mathur Hospital   Operation Theatre Complex First Floor Mathura Das Mathur Hospital Dr S N Medical College Department Of Anaesthesiology And Critical Care Jodhpur RAJASTHAN
Jodhpur
RAJASTHAN 
9414803554

geetamanojkamal@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Dr S N Medical College Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K566||Other and unspecified intestinal obstruction,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Group A  Patients will receive bilateral rectus sheath block using 40 ml of 0.25% levobupivacaine with 2 ml of normal saline, 21 ml on each side and 2 ml of normal saline i.v. 
Comparator Agent  Group B  Patients will receive bilateral rectus sheath block using 40 ml of 0.25% levobupivacaine with 2 ml (8 mg) of dexamethasone, 21 ml on each side and 2 ml of normal saline i.v. 
Comparator Agent  Group C  Patients will receive bilateral rectus sheath block using 40 ml of 0.25% levobupivacaine with 2 ml of normal saline, 21 ml on each side and 2 ml (8mg) of dexamethasone i.v. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Age between 18 to 60 yr
2. Body weight 40 to 80 kg
3. Patients belong to American Society of Anaesthesiologists (ASA) grade I and II
4. Patients scheduled for elective laparotomy surgeries under general anaesthesia.
 
 
ExclusionCriteria 
Details  1. Patients refusal
2. Local infection at the block site
3. Coagulopathy
4. Morbid obesity or body mass index (BMI >40)
5. Allergy to local anaesthetics
6. Any chronic systemic illness
7. Patients on steroid treatment
8. Pre-existing peripheral neuropathy or neurological deficits
9. Psychiatric illness
10. Patients on anticoagulants
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the duration of analgesia (time to first rescue analgesia after administration of block)   24 Hours 
 
Secondary Outcome  
Outcome  TimePoints 
1.To compare post-operative rescue analgesic (morphine) consumption in first 24 h
2.To compare NRS Pain scores at rest and on cough in first 24 h
3.Hemodynamic monitoring in first 24 h
4.Patient’s satisfaction score
5.Any complications / adverse effects/side effects of block
 
24 Hours 
 
Target Sample Size   Total Sample Size="105"
Sample Size from India="105" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)
Modification(s)  
01/12/2018 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary   This prospective, randomized study will be conducted in the Department of Anaesthesiology, Dr. S. N. Medical College and attached group of hospitals, Jodhpur, after approval from institutional ethical committee. The patients will be randomly selected from the patients posted for elective laprotomy, under general anaesthesia after confirming all inclusion and exclusion criteria. A written informed consent will be taken from all the patients for performance of block after complete explanation about the study protocol, anaesthetic technique, merits and demerits of the procedure in perioperative course of anaesthesia All selected patients will be undergo a routine pre-anaesthetic check-up (PAC), including explanation of numeric rating scale (NRS) pain scale (0-10, where 0 stands for no pain and 10 stands for worst imaginable pain) for post-operative pain assessment. All the patients will be kept nil per oral as per the fasting guidelines. All patients will be premedicated with tab alprazolam 0.5 mg orally night before the surgery. 
In the operative room, identification of patient, fasting status, consent and PAC will be confirmed. After reassuring the patient, standard ASA monitoring will be applied. Base line heart rate (HR), non- invasive systolic blood pressure (SBP), diastolic blood pressure (DBP) and mean blood pressure (MAP), respiratory rate (RR), and peripheral oxygen saturation (SpO2) will be recorded. Continuous electrocardiographic (ECG) monitoring will be done. Peripheral i.v.cannulation will be done by using 18G cannula in the upper limb and lactated ringer’s solution 10 ml/kg will be started.

The general anaesthesia will be induced with injection fentanyl (1.5 -2μg/kg) and propofol (1.5 - 2.0 mg/kg). The endotracheal intubation will be facilitated by using muscle relaxant atracurium besylate (0.5mg/kg) after confirming adequacy of ventilation and loss of consciousness. The airway will be secured with appropriate size of endotracheal tube. The anaesthesia will be maintained with air oxygen (50:50), isoflurane and atracurium besylate. Supplemental analgesia will be providing with injection fentanyl (1 μg/kg) when rise in HR or MAP more than 20% of base line values. Continuous monitoring of HR, NIBP, SpO2 and end tidal carbon-dioxide (EtCO2) will be done throughout intra operative period and recorded every 15 min. The EtCO2 will be maintained between 35-40 mm Hg. The number of doses and total amount of supplement analgesia intra operative with fentanyl will be recorded for comparison between two groups. Fifteen min before surgery completion ondansetron 8 mg i.v. given. After completion of surgery bilateral rectus sheath block will be given according to allocated group. 

Rectus sheath block will be given  under all aseptic precaution as per study group, with real-time ultra-sonographic guidance (13-6 MHz Linear Array Transducer; Sonosite M-Turboâ„¢, Bothell, WA, USA) using a 22G (0.70 mm × 50 mm) via an in-plane approach to the rectus sheath.The probe will be placed horizontally over the rectus sheath at T10 level on either side of the midline.The posterior rectus muscle sheath and the fascia transversalis will be identified as twin hyperechoic lines. A Stimuplex®A insulated needle (B. Braun, Melsungen, Germany) connected to an infusion line was introduced in plane with the US probe in a medial to lateral direction at an angle of approximately 45° to the skin plane. Under real-time US guidance, the needle will be gradually advanced posterior to the rectus muscle and above the underlying rectus sheath toward its lateral edge, approaching the rectus sheath with the blunt side of the bevel, lateral to the deep inferior epigastric artery to avoid damaging it with the needle. Following negative aspiration testing, a bolus of 1 mL of 21 mL drug solution will be slowly injected through the needle. If intramuscular spread of the LA occurred, the needle will be advanced until the rectus muscle will be separated from the posterior rectus sheath by hydrodissection.  At this point, the remaining anesthetic solution will be deposited under US guidance. The same procedure will be repeated on the opposite side.

After performing the block, residual neuromuscular blockade will be reversed with neostigmine 0.05 mg/kg and glycopyrrolate 0.01 mg/kg i.v. and the trachea will be extubated when the patient is fully awake and breathing adequately. The patients will be shifted to the post anaesthesia recovery unit (PACU) for further management. The total duration of the surgery will be also recorded. Post operatively patients will be given morphine 3 mg i.v. as rescue analgesia, if NRS ≥4.  HR, NIBP, SpO2, RR and NRS score will be recorded at 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22 and 24 h after the surgery. Time to first rescue analgesia as well as the total doses of morphine used in first 24 h will be recorded. Any side effects like nausea, vomiting, respiratory depression, hypotension, sign and symptoms of local anaesthetic toxicity will be recorded and treated accordingly. Nausea lasting more than 10 min or vomiting will be treated with ondansetron 4mg i.v.The patient’s satisfaction score will be noted.

The following characteristics of the block will be observed postoperatively: 1.      Duration of analgesia: Duration of analgesia will be defined as the time interval from completion of local anesthetic administration till first need of rescue analgesic. The rescue analgesic regime morphine3 mgi.v. slowly as analgesic whenever NRS ≥ 4 or on request. 

2. Pain assessment: The numerical rating scale (NRS) is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0–10 integers) that best reflects the intensity of his/her pain. The common format is a horizontal bar or line which contains 11-point numeric scale ranges from ’0’ representing one pain extreme (e.g. “no pain”) to ’10’ representing the other pain extreme (e.g. “pain as bad as you can imagine”or “worst pain imaginable”). NRS for pain will be assessed during rest (NRS-R) and movement (NRS-M) at predefined intervals at 0, 2, 4, 6, 8, 10, 12, 15, 18, 21 and 24 h postoperatively.

3. Total rescue analgesic consumption: The total dose of morphine used in initial 24 h.

4. Postoperative side effects or complications: Local anesthetic toxicity, nausea, vomiting, pruritus, drowsiness, convulsions etc.

5. Hemodynamic and respiratory changes: Bradycardia (pulse <50 beats/min), hypotension (reduction of MAP >20% of baseline), respiratory depression (RR ≤8 breaths/minute or SpO2< 90%).

6. Patient’s satisfaction score:    4 = excellent, 3 = good, 2 = fair, 1 = poor. 

 
Close