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临床试验/CTRI/2024/06/068436
CTRI/2024/06/068436尚未招募Phase 3 4

Incidence and risk factors associated with development of rebound pain after peripheral nerve block in trauma surgeries: an observational study

Post Graduate Institute of Medical Education and Research (PGIMER), chandigarh1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年6月26日最近更新:

试验速览

阶段
Phase 3 4
状态
尚未招募
发起方
入组人数
100
试验地点
1
主要终点
The primary outcome variable for this study is the incidence of rebound pain in Trauma patients undergoing surgery under regional block.

研究概览

简要总结

This single-centre prospective cohort study will be conducted at   Advanced Trauma Centre located at Post Graduate Institute of Medical education and research Chandigarh, India.

The preoperative assessment of pain at rest and pain during the previous 24 hrs at the operative site will be assessed using a numeric rating scale (NRS) from 0 to 10 (where 0.no pain and 10 worst possible pain) In the operating room, procedure will be performed by treating anaesthesiologist as per institute protocol with dexamethasone 4mg as additive to volume of drug given for block. Patients will be followed up for 24 hrs after surgery. Age, gender, BMI, baseline pain scores and ASA physical status will be included as patient factors. Surgical site and involvement of bone (e.g. debridement, fixation, amputation, tendon repair) will be included as surgical factors. Local anaesthetic type and dose, type of PNB, use of additive will be included as anaesthetic factors. Type of PNB will be grouped as brachial plexus block (axillary, supraclavicular, or infraclavicular block), interscalene block (ISB), sciatic nerve block (subgluteal and popliteal blocks), and distal PNBs (e.g. ankle and wrist blocks). Pain scores in the PACU and post-discharge use of acetaminophen and NSAIDS will be included as postoperative factors. Durations of motor block and sensory block will be calculated from block time to when the patients reported motor and sensory resolution of the block, respectively. We will exclude patients who received peripheral nerve blocks for analgesia with general anaesthesia.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • age 18 years to 65 years having traumatic injuries of upper or lower limb
  • undergoing surgical procedure under peripheral nerve block
  • able to understand Numerical rating scale.

排除标准

  • patients who received peripheral nerve blocks for analgesia with general anaesthesia.
  • patients with head injury.

结局指标

主要结局

The primary outcome variable for this study is the incidence of rebound pain in Trauma patients undergoing surgery under regional block.

时间窗: on arrival, post operative 30 min, 2 hrs, 4 hrs, 8 hrs, 12 hrs, 24 hrs, 48 hrs

次要结局

  • 1. severity (amplitude) of the Rebound pain(2. Risk factors for rebound pain like demographic factor, type of block, duration and nature of surgery)

研究者

发起方
Post Graduate Institute of Medical Education and Research (PGIMER), chandigarh
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Jeetinder Kaur Makkar

Post Graduate Institute of Medical Education and Research, Sector 12, Chandigarh.

研究点 (1)

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