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Clinical Trials/CTRI/2024/07/070716
CTRI/2024/07/070716RecruitingNot Applicable

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

AIIMS Bibinagar1 site in 1 country106 target enrollmentStarted: July 29, 2024Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Sponsor
Enrollment
106
Locations
1
Primary Endpoint
The total volume of local anaesthetic administered via epidural catheter over the first 48 h post-operatively to provide effective analgesia.

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
None

Eligibility Criteria

Ages
19.00 Year(s) to 60.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • ASA 1 or 2, Patients undergoing elective lower abdominal surgeries with horizontal incision.

Exclusion Criteria

  • 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.

Outcomes

Primary Outcomes

The total volume of local anaesthetic administered via epidural catheter over the first 48 h post-operatively to provide effective analgesia.

Time Frame: Forty eight hours after surgery

Secondary Outcomes

  • Quality of analgesia for 48hr after surgery (VAS :Visual analogue pain scores )(Forty eight hours after surgery)

Investigators

Sponsor
AIIMS Bibinagar
Sponsor Class
Government medical college
Responsible Party
Principal Investigator
Principal Investigator

Syama sundar Ayya

AIIMS Bibinagar

Study Sites (1)

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