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CTRI Number  CTRI/2019/01/017134 [Registered on: 17/01/2019] Trial Registered Prospectively
Last Modified On: 13/01/2019
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparison of two techniques namely,an abdominal muscle block on both sides of the incision wound and a local skin wound block using a local anesthetic named Bupivacaine for providing effective pain relief after surgery in emergency surgeries involving midline abdominal incision.  
Scientific Title of Study   Efficacy of bilateral rectus sheath block with bupivacaine for postoperative analgesia in patients undergoing emergency midline laparotomy compared to local wound infiltration with bupivacaine-A randomised controlled 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 Akshay LH 
Designation  Junior Resident 
Affiliation  Jawaharlal Institute of Postgraduate Medical Education and Research 
Address  Department of Anesthesiology and critical care,Dhanvantari Nagar,JIPMER

Pondicherry
PONDICHERRY
605006
India 
Phone  9585522595  
Fax    
Email  aakshaylh@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Srinivasan Swaminathan 
Designation  Assistant Professor 
Affiliation  Jawaharlal Institute of Postgraduate Medical Education and Researc 
Address  Department of Anesthesiology and critical care,Dhanvantari Nagar,JIPMER

Pondicherry
PONDICHERRY
605006
India 
Phone  9626493045  
Fax    
Email  srinianaes@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Dr Srinivasan Swaminathan 
Designation  Assistant Professor 
Affiliation  Jawaharlal Institute of Postgraduate Medical Education and Researc 
Address  Department of Anesthesiology and critical care,Dhanvantari Nagar,JIPMER

Pondicherry
PONDICHERRY
605006
India 
Phone  9626493045  
Fax    
Email  srinianaes@yahoo.co.in  
 
Source of Monetary or Material Support  
Jawaharlal Institiute of Postgrduate Medical Education and Research,Dhanvantari Nagar,JIPMER,Puducherry-605006 
 
Primary Sponsor  
Name  Jawaharlal Institiute of Postgrduate Medical Education and Research 
Address  Dhanvantari Nagar,JIPMER,Puducherry-605006 
Type of Sponsor  Research institution and hospital 
 
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 
Dr Akshay LH  Jawaharlal Institute of Postgraduate Medical Education and Research  Anesthesiology office,2nd floor,hospital block,Department of Anesthesiology and critical acre,JIPMER,Dhanvantari nagar.
Pondicherry
PONDICHERRY 		 9585522595

aakshaylh@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
JIPMER Institute Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K659||Peritonitis, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Rectus sheath Block under ultrasound guidance with Bupivacaine.  Rectus sheath Block with Bupivacaine will be given by me under ultrasound guidance at the end of surgery for post-operative pain relief. 
Comparator Agent  Wound Infilteration Technique with Bupivacaine  Wound Infilteration will be given by surgeon with Bupivacaine at the end of surgery. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  All individuals with 18-70years of age, undergoing emergency midline (both supra and infra umbilical) laparotomy surgeries belonging to American Society of Anaesthesiologist’s category 1 to 3 in JIPMER. 
 
ExclusionCriteria 
Details  i.Patients requiring ventilator support.
ii.Patients having coagulopathy or bleeding disorders.
iii.Patients with severe hepatic or renal impairments.
iv.Patients having local abdominal wound infections.
v.Pregnant women
vi.Allergy to local anesthetics
vii.Patients not willing for the study
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the analgesic effect in the post-operative period through bilateral rectus sheath block with Bupivacaine and local infiltration with Bupivacaine by using the Visual Analogue Scale (VAS)  Time in hours.Visual Analogue Scale (VAS) is assessed at 1,4,8,12,24 hours after surgery to detect any pain in both bilateral rectus sheath block and local infilteration technique. 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the morphine consumption in the post-operative period between the two groups.  Time in minutes/hours.Cumulative morphine consumption in milligrams in the first 24 hours is noted in the post-opearative period according to the requirement in both the groups under study. 
Time to requisition of first analgesic.  Time in minutes/hours.Time required for first analgesic for the patient is noted in the post-opeartive period according to the need of the patient in both the groups.  
Incidence of post-operative nausea,vomiting.  Number in numericals.The number of episodes of nausea and vomiting in the first 24 hours post-operative period is assessed using a PONV Impact Scale Score which consists of two quessionaire and adding the numerical number corresponding to the response to both the questions. 
To compare the Heart rate,Blood pressure,Saturation and Respiratory rate in the two groups in the postoperative period.  Time in minutes/hours.Baseline Heart rate in beats per minute,Blood pressure in millimeters of mercury,Saturation in percentage and Respiratory rate per minute is noted before surgery and after extubation and also every 4th hourly till 12 hours and then at 24 hours. 
Patient satisfaction of post-operative analgesia in the first 24 hours.  Number in numericals.patient satisfaction of analgesia is assessed in the post-opeartive period using LIKERTS Scale. 1-Very dissatisfied 2-dissatisfied 3-unsure
4-satisfied 5-very satisfied.
 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   01/03/2019 
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   Post-operative pain has the potential for significant adverse effects on the physiology and can also drown the patient into psychological suffering. The source and degree of nociceptive stimulation differ among individuals and surgeries and hence an effective analgesic approach could be encouraged for pain relief. Thoracic epidural analgesia is invaluable in providing excellent post-operative analgesia and aid in early recovery. But in many patients undergoing emergency surgeries initiation of thoracic epidural anaesthesia is not feasible due to various reasons like difficulties in patient positioning secondary to pain, haemodynamic disturbance or coagulation abnormalities. Epidural analgesia also has some disadvantages of predisposing to hypotension and motor weakness during the postoperative period.There is a growing interest in bilateral rectus sheath block in patients who underwent emergency laparotomy with midline incision as part of multimodal therapy in the management of post-operative pain.There are not much Randomized Controlled Trials comparing the efficacy of bilateral rectus sheath block with that of wound infilteration with local anesthetic for post-operative analgesia in emergency abdominal surgeries with midline incision.

With the current emphasis on fast-tracking after surgery and considering the fact that opioids contribute to nausea, vomiting, and ileus; it is necessary to have a viable alternative for pain management. Bilateral rectus sheath blocks provide a feasible option for effective pain management in these scenario. Successful management of post-operative pain with bilateral rectus sheath  blocks has been reported.

The study hypothesis is that Bilateral rectus sheath block with Bupivacaine is more efficacious in reducing the post-operative pain score when compared to wound infiltration with Bupivacaine in emergency midline laparotomy surgeries during the first 24 hours  
 
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