Ultrasound guided retrolaminar block versus ultrasound guided erector spinae plane block for post operative analgesia in percutaneous nephrolithotomy; a randomised comparative study.
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- To compare the total duration of analgesia.
研究概览
简要总结
This study will be a prospective randomised, double blinded, parallel group, single hospital, comparative study comparing the effects of ultrasound guided erector spinae plabe block versus ultrasound guided retrolaminar block on post operative analgesia in patients undergoing percutaneous nephrolithotomy. The null hypothesis of our study is that there is no difference in the duration of analgesia after erector spinae plane block and retrolaminar block in patients undergoing percutaneous nephrolithotomy.
AIM: To compare the analgesia after ultrasound guided unilateral retrolaminar block with ultrasound guided unilateral erector spinae plane block in patients undergoing percutaneous nephrolithotomy.
PRIMARY OBJECTIVE: To compare the duration of analgesia , that is, the time from injection of the drug administration to the patients first request for rescue analgesia or NRS score > 4, between two groups.
SECONDARY OBJECTIVE:
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To compare the pain NRS scores at rest and during cough postoperatively after extubating, between two groups.
-
To calculate the total analgesic requirement in first 24hours between two groups.
-
To compare any complications, like , post operative nausea and vomiting, post operative shivering, pneumothorax and any other between the two groups.
REFERENCES
1.Role of Erector Spine Plane Block for Postoperative Analgesia in Patients Undergoing Percutaneous Nephrolithotomy Bhatia R, Asthana V, Sarpal R, Bindal K - MAMC J Med Sci (mamcjms.in)
2.Comparison of erector spinae plane block and local anaesthetic infiltration of the incision site for postoperative analgesia in percutaneous nephrolithotomy – A randomised parallel-group study - PMC (nih.gov)
3.Craig DB. Post-operative recovery of pulmonary function. Anesth Anal 1981;60:46 -52.
4.Comparison of Clinical Efficacy and Anatomical Investigation between Retrolaminar Block and Erector Spinae Plane Block (hindawi.com)
5.Effects of erector spinae plane block and retrolaminar block on analgesia for multiple rib fractures: a randomized, double-blinded clinical trial – ScienceDirect
6.Safety and effectiveness of ultrasound-guided RLB and ESPB | JPR (dovepress.com)
7.International Journal of Medical Science in Clinical Research and Review (ijmscrr.in)
- Kerai S, Saxena KN, Taneja B. : What is new? Indian J Anaesth. 2017;61:200-14
9.Erector Spinae Plane Block - StatPearls - NCBI Bookshelf (nih.gov)
- The ultrasound-guided retrolaminar block - PubMed (nih.gov)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •American Society of Anaesthesiology Physical Status 1, 2 and 3 Scheduled for elective percutaneous nephrolithomy under general anaesthesia.
排除标准
- •Patients not willing to give consent
- •Allergy to the study drugs.
- •Infection at the site of the block.
- •Cardiovascular diseases
- •Chronic obstructive pulmonary disease.
- •Other major systemic illness.
- •Patient having history of substance abuse
- •Patient with delirium and on antipsychotic medication.
- •Disorder of coagulation.
- •Patients having chronic pain and on chronic analgesic medications.
结局指标
主要结局
To compare the total duration of analgesia.
时间窗: Time from injection of the drug to the patients first request for rescue analgesia or NRS score more than 4, between the two groups.
次要结局
- 1.To compare the pain NRS scores at rest & during cough postoperatively after extubating between the two groups.(2.To calculate the total analgesic requirement in first 24hours between the two groups.)
研究者
Dr Birina Kakaty
Gauhati Medical College and Hospital