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CTRI Number  CTRI/2021/07/034703 [Registered on: 08/07/2021] Trial Registered Prospectively
Last Modified On: 06/07/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   COMPARISON OF ULTRASOUND GUIDED RECTUS SHEATH BLOCK AND OBLIQUE SUBCOSTAL TRANSVERSUS ABDOMINIS PLANE BLOCK FOR PERIOPERATIVE ANALGESIA FOR MIDLINE INCISION ABDOMINAL SURGERIES 
Scientific Title of Study   Ultrasound guided rectus sheath block and oblique subcostal transversus abdominis plane block for perioperative analgesia in midline incision abdominal surgery: A double blind, prospective, randomized comparative study. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DR SARAVJOT KAUR SANDHU 
Designation  JUNIOR RESIDENT  
Affiliation  Department of Anaesthesia, MAHATAM GANDHI MEDICAL COLLEGE AND HOSPITAL , JAIPUR  
Address  DEPARTMENT OF ANAESTHESIOLOGY , GENERAL OT , MAHATAMA GANDHI MEDICAL COLLEGE AND HOSPITAL RICCO INDUSTRIAL AREA SITAPURA JAIPUR RAJASTHAN 302022

Jaipur
RAJASTHAN
302022
India 
Phone  8847662441  
Fax    
Email  sandhusabinaz@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR DURGA JETHAVA 
Designation  HEAD OF DEPARTMENT DEPARTMENT OF ANAESTHESIOLOGY  
Affiliation  Department of Anaesthesia, MAHATAM GANDHI MEDICAL COLLEGE AND HOSPITAL , JAIPUR  
Address  DEPARTMENT OF ANAESTHESIOLOGY , MAHATAMA GANDHI MEDICAL COLLEGE AND HOSPITAL RICCO INDUSTRIAL AREA SITAPURA JAIPUR RAJASTHAN 302022

Jaipur
RAJASTHAN
302022
India 
Phone  9680064336  
Fax    
Email  djethava@gmail.com  
 
Details of Contact Person
Public Query  
Name  DR SARAVJOT KAUR SANDHU 
Designation  JUNIOR RESIDENT  
Affiliation  Department of Anaesthesia, MAHATAM GANDHI MEDICAL COLLEGE AND HOSPITAL , JAIPUR  
Address  DEPARTMENT OF ANAESTHESIOLOGY , GENERAL OT ,MAHATAMA GANDHI MEDICAL COLLEGE AND HOSPITAL RICCO INDUSTRIAL AREA SITAPURA JAIPUR RAJASTHAN 302022

Jaipur
RAJASTHAN
302022
India 
Phone  8847662441  
Fax    
Email  sandhusabinaz@gmail.com  
 
Source of Monetary or Material Support  
MAHATMA GANDHI MEDICAL COLLEGE AND HOSPITAL SITAPURA JAIPUR  
 
Primary Sponsor  
Name  NONE 
Address  NONE 
Type of Sponsor  Other [] 
 
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 Saravjot Kaur Sandhu  Mahatma Gandhi Medical College & Hospital  Department of anaethesia , OT complex , ,Mahatma Gandhi Medical College & Hospital, RIICO Institutional Area, Tonk Rd, Sitapura, Jaipur, Rajasthan 302022
Jaipur
RAJASTHAN 		 8847662441

sandhusabinaz@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
OfficeoftheInstitutionalEthicsCommittee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C19||Malignant neoplasm of rectosigmoidjunction, (2) ICD-10 Condition: C179||Malignant neoplasm of small intestine, unspecified, (3) ICD-10 Condition: C569||Malignant neoplasm of unspecifiedovary,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
Intervention  oblique subcostal Transversus abdominis plane block   A USG linear array probe with high- or an intermediate-frequency linear probe of 35 to 40 mm will provide adequate imaging. A needle of up to 15 to 20 cm in length , bend into a slight curve will be required , decribed by Hebbard et al .15 The operator will stand on the left side of the patient in the supine position, and both sides are blocked from this position, with the right hand holding the needle and the left hand holding the probe. To perform the block, the rectus abdominis and underlying transversus abdominis muscles will be identified near the costal margin and xyphoid. Local anesthetic is injected incrementally in the TAP (hydrodissection) by a needle passing along the oblique subcostal line extending inferolaterally from the xyphoid toward the anterior part of the iliac crest. The skin will be punctured 2 to 3 cm from the probe and then the probe will be moved toward the needle to image it in-plane. A larger volume of local anaesthetic 40 ml of 0.25% bupivacaine will be used to facilitate hydrodissection, which may improve the spread of the block. Initially, a 1- to 2-mL volume of local anesthetic will be injected between the rectus abdominis and the transversus abdominis muscles to confirm correct placement of the needle tip. Using needle advancement and hydrodissection (starting near the xiphoid and costal margin), the needle will be passed between rectus abdominis sheath and the transversus abdominis. It will then directed beneath the aponeurosis of the linea semilunaris and passed through the fascial layer of the internal abdominis and transversus abdominis muscles toward the anterior portion of the iliac crest.( Described by Yue Chen et al16) The procedure will be repeated on the opposite side. All standard aseptic precautions will be taken.  
Intervention  Rectus sheath block  A USG machine with linear array probe (5-12MHz) with an imaging depth of 4-6cm will be used for performing the block. The ultrasound probe will be placed transverse on abdomen, immediately lateral (3 cm) to umbilicus. A 20-gauge needle will be inserted in-plane in a medial to lateral orientation, through the subcutaneous tissue, to pierce through the anterior rectus sheath. Upon identification of the rectus muscle and hyperechoic twin lines deep to it (posterior rectus sheath and fascia transversalis) in the ultrasound image the needle tip will be advanced to the desired position, posterior to the rectus muscle and above the underlying posterior rectus sheath under direct vision. Following confirmation of the correct position of the needle tip with hydro dissection of the rectus muscle away from the posterior rectus by administration of 0.5–1ml of normal saline; 20ml of 0.25% bupivacaine will be administered for block performance. The procedure will be repeated on the opposite side.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Patient fulfilling criteria of American Society of Anaesthesiology (ASA) of Classes I/II.
Patient aged 18-65 years.
Patients undergoing Midline incision abdominal surgeries under general anaesthesia.
Patient’s giving consent willingly.

 
 
ExclusionCriteria 
Details  Patient with ASA CLASSIII,IV & V.
Patient refusal.
Allergy to study medications
Infection at the site of proposed block.
Anatomic abnormalities.
Inability to comprehend or participate in pain scoring system. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
• To assess the analgesic efficacy of rectus sheath block.
• To assess the analgesic efficacy of oblique subcostal TAP block.
• To compare the analgesic efficacy of both blocks.
 		 24 hrs 
 
Secondary Outcome  
Outcome  TimePoints 
To note and compare requirement of supplementalanalgesic during   surgery in both thegroupsTocompare intraoperative hemodynamic parameters heart rate  systolic bloodpressure diastolic blood pressure mean arterial pressure in both groupsToassess and compare postoperative visual analogue scale  score  at rest and with movement Time torequest for first rescue analgesia in both the groups Totaldose of tramadol required in 24 hrs   24 hrs 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   19/07/2021 
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    
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

·      Patients undergoing abdominal surgical procedures with midline incision experience significant pain.

·      Postoperative pain therapy is a key element of efficient postoperative care. Inadequate pain control may delay the recovery of patients, prolong hospital stay, increased expenses and may precipitate chronic pain.

·      Historically, pain control is accomplished through opioid administration, which is associated with side effects such as sedation, respiratory depression, pruritus, hallucinations, postoperative nausea and vomiting (PONV). Administration of multimodal analgesics could limit the excessive use of systemic opioid analgesia.

·      Epidural analgesia remains the gold standard for pain control for abdominal surgical procedures. .However,  epidural  analgesia  complications include  hypotension,  bradycardia,  dural  puncture, spinal  infection, immobilization due to motor block, urine retention and rarely neurological damage.

·      Due to these risks, alternative approaches to traditional anesthetic techniques should also be assessed.The idea of oblique subcostal transversus abdominis plane block (OSTAPB) and rectus sheath block is to anesthetize part of or the entire abdominal wall instead of using intrathecal or epidural techniques.

·      These blocks may also be effective in reducing postoperative pain in midline incisional abdominal surgery as an alternative method of epidural analgesia in anticoagulated patients.

·      The rectus sheath block was first described by Schleich in 1899 as a means of facilitating surgery involving the anterior abdominal wall in adults.It was initially used for abdominal wall muscle relaxation and analgesia during midline laparotomy by blocking the terminal branches of the9th, 10th and 11th intercostal nerves located in the space between the rectus abdominis muscle and its posterior rectus sheath. It has been used for postoperative analgesia extending along the midline for upper abdominal surgeries, abdominal gynecological procedures, and abdominoplasty.

·      The oblique subcostal transversus abdominis plane block (OSTAPB) is a regional anesthetic technique that targets the injection of the local anesthetic (LA) in the neurovascular plane between the rectus abdoiminis muscle and transversus abdominis muscle.Hebbardet al. (2010) described the US-guided continuous oblique subcostal TAP block. With a single oblique subcostal TAP block (OSTAPB) injection, the sensory block extends to the thoracolumbar nerves (T6-L1) making the block beneficial for midline abdominal incisions also.

 
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