跳至主要内容
临床试验/CTRI/2024/07/070716
CTRI/2024/07/070716招募中不适用

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 个研究点 分布在 1 个国家目标入组 106 人开始时间: 2024年7月29日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
106
试验地点
1
主要终点
The total volume of local anaesthetic administered via epidural catheter over the first 48 h post-operatively to provide effective analgesia.

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
19.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

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

排除标准

  • 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.

结局指标

主要结局

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

时间窗: Forty eight hours after surgery

次要结局

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

研究者

发起方
AIIMS Bibinagar
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Syama sundar Ayya

AIIMS Bibinagar

研究点 (1)

Loading locations...

相似试验