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CTRI Number  CTRI/2024/07/070716 [Registered on: 16/07/2024] Trial Registered Prospectively
Last Modified On: 06/08/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Continuous infusion VS Intermittent bolus method of Epidural infusion method to improve postoperative analgesia  
Scientific Title of Study   A Comparative study on Efficacy of two different methods of administering the epidural ropivacaine for postoperative analgesia in patients undergoing lower abdominal surgeries.: a randomized study 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Syama sundar Ayya 
Designation  Additional Professor 
Affiliation  AIIMS Bibinagar 
Address  Additional Professor, Department of Anaesthesiology, AIIMS Bibinagar, Yadadri Bhuvanagiri district

Nalgonda
TELANGANA
508126
India 
Phone  8179309677  
Fax    
Email  sasyasyama@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Syama sundar Ayya 
Designation  Additional Professor 
Affiliation  AIIMS Bibinagar 
Address  Additional Professor, Department of Anaesthesiology, AIIMS Bibinagar, Yadadri Bhuvanagiri district

Nalgonda
TELANGANA
508126
India 
Phone  8179309677  
Fax    
Email  sasyasyama@gmail.com  
 
Details of Contact Person
Public Query  
Name  Syama sundar Ayya 
Designation  Additional Professor 
Affiliation  AIIMS Bibinagar 
Address  Additional Professor, Department of Anaesthesiology, AIIMS Bibinagar, Yadadri Bhuvanagiri district

Nalgonda
TELANGANA
508126
India 
Phone  8179309677  
Fax    
Email  sasyasyama@gmail.com  
 
Source of Monetary or Material Support  
All India Insititute of Medical Sciences, BIBINAGAR 
 
Primary Sponsor  
Name  AIIMS Bibinagar 
Address  Rangapur village, Bibinagar. Mandal ( Near Hyderabad),. Yadadri Bhuvanagiri. District, Telangana State,. Pin: 508126. 
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 
Ayya Syama Sundar  AIIMS Bibinagar  room no G 35 and 36, OT complex, Dept. of Anaesthesiology , AIIMS Bibinagar,Hyderabad metropolitan region
Nalgonda
TELANGANA 		 8179309677

sasyasyama@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE (AIIMS BBN IEC)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Continuous Epidural Infusion of Ropivacaine  0.2% concentration of Ropivacaine will be continuously infused at a rate of 5 mL per hour by syringe pump. Infusion will be started after 1 hour of epidural loading dose till 48 hours after surgery. Additional 5 mL of same drug will be given as bolus if Visual analog pain score is more than 3,with a lock out time of 20 minutes. 
Intervention  Manual Intermittent Epidural Bolus of Ropivacaine  5 mL of 0.2% concentration of Ropivacaine will be given hourly after 1 hour of epidural loading dose till 48 hours after surgery. Additional 5 mL of same drug will be given as bolus if Visual analog pain score is more than 3,with a lock out time of 20 minutes. 
 
Inclusion Criteria  
Age From  19.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  ASA 1 or 2, Patients undergoing elective lower abdominal surgeries with horizontal incision 
 
ExclusionCriteria 
Details  ASA grade 3,4 or 5,Known bleeding diathesis, Surgeries exceeding more than 2hrs, Neuromuscular disease ,Local skin infections/Contraindications to neuraxial anaesthesia ,Patient with severe cardiovascular,respiratory,renal or hepatic diseases, Patients refusal, Allergy to any of the study medications, Patients on psychiatric or chronic pain medication
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The total volume of local anaesthetic administered via epidural catheter over the first 48 h post-operatively to provide effective analgesia.  Forty eight hours after surgery 
 
Secondary Outcome  
Outcome  TimePoints 
Quality of analgesia for 48hr after surgery (VAS :Visual analogue pain scores )   Forty eight hours after surgery 
 
Target Sample Size   Total Sample Size="106"
Sample Size from India="106" 
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)   29/07/2024 
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="2"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Epidural instillation is an effective neuraxial analgesic technique that has been used to manage postoperative pain for decades(1). In recent years, the efficacy of the programmed intermittent epidural bolus (PIEB) technique has been well demonstrated for labor analgesia . PIEB is an automated method of administering boluses of local anesthetic solution into the epidural space at fixed, scheduled time intervals. PIEB prolongs the duration of analgesia, reduces motor block, lowers the incidence of breakthrough pain, improves maternal satisfaction, and decreases local anaesthetic consumption compared with continuous epidural infusion (CEI)(2,3) .

Several studies have shown the benefits of PIEB compared with CEI in different types of surgery.

Ueda et al. reported that PIEB using ropivacaine 0.75% resulted in a more extensive dermatomal spread as measured by loss of sensation compared with CEI following gynaecologic surgery(4)

Epidural analgesia is associated with a significant improvement in postoperative pain control, lower requirement of opioids, and enhanced clinical outcomes compared with parenteral opioids after major abdominal surgery(5)

In labor analgesia, recent studies have demonstrated a local anesthetic-sparing effect, lesser motor blockade, and higher maternal satisfaction with PIEB compared to that with CEI (6). However, because of different pain entities and the target spinal level in major abdominal surgery compared with labor analgesia, the clinical application of PIEB in abdominal surgery might be limited. Few studies have compared the use of PIEB versus CEI after major abdominal surgery, (7) and two studies showed inconsistent postoperative outcomes.

PIEB requires specific infusion pump, facility for electricity connection, tubing from the pump to epidural catheter and trained personnel for operation..

Manual (MIEB) can be administered to achieve all the benefits of PIEB without the requirement of any specialised equipment, which maybe very helpful in resource constraint settings .

 In this study, we would like to compare the efficacy of postoperative analgesia using MIEB versus CEI with  epidural analgesia.

References

1.   B. M. Block, S. S. Liu, A. J. Rowlingson, A. R. Cowan, J. A. Cowan Jr., and C. L. Wu, “Efcacy of postoperative epidural analgesia: a meta-analysis,” Journal of the American Medical Association, vol. 290, no. 18, pp. 2455–2463, 2003

2.   R. B. George, T. K. Allen, and A. S. Habib, “Intermittent epidural bolus compared with continuous epidural infusions for labor analgesia: A systematic review and meta-analysis,” Anesthesia & Analgesia, vol. 116, no. 1, pp. 133–144, 2013.

3.  B. Carvalho, R. B. George, B. Cobb, C. McKenzie, and E. T. Riley, “Implementation of Programmed Intermittent Epidural Bolus for the Maintenance of Labor Analgesia,” Anesthesia & Analgesia, vol. 123, no. 4, pp. 965–971, 2016.

4.   K. Ueda, W. Ueda, and M. Manabe, “A comparative study of sequential epidural bolus technique and continuous epidural infusion,” Anesthesiology, vol. 103, no. 1, pp. 126–129, 2005.

5.  Werawatganon T, Charuluxanun S. Patient controlled intravenous opioid analgesia versus continuous epidural analgesia for pain after intra-abdominal surgery. Cochrane Database Syst Rev. 2005 Jan 25;(1):CD004088. doi: 10.1002/14651858.CD004088.pub2. Update in: Cochrane Database Syst Rev. 2013;3:CD004088. PMID: 15674928.

6.  George RB, Allen TK, Habib AS. Intermittent epidural bolus compared with continuous epidural infusions for labor analgesia: a systematic review and meta-analysis. Anesth Analg. 2013 Jan;116(1):133-44. doi: 10.1213/ANE.0b013e3182713b26. Epub 2012 Dec 7. Erratum in: Anesth Analg. 2013 Jun;116(6):1385. PMID: 23223119.

7.  Wiesmann T, Hoff L, Prien L, Torossian A, Eberhart L, Wulf H, Feldmann C. Programmed intermittent epidural bolus versus continuous epidural infusion for postoperative analgesia after major abdominal and gynecological cancer surgery: a randomized, triple-blinded clinical trial. BMC Anesthesiol. 2018 Oct 30;18(1):154. doi: 10.1186/s12871-018-0613-6. PMID: 30376810; PMCID: PMC6208106.

 
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