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临床试验/CTRI/2024/12/077619
CTRI/2024/12/077619尚未招募不适用

Incidence and severity of chronic pain and its impact on quality of life in patients undergoing major reconstructive head and neck cancer surgery: A Prospective observational study

Tata Memorial Hospital1 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2024年12月16日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
250
试验地点
1
主要终点
Incidence and severity of chronic postoperative pain in patients undergoing

研究概览

简要总结

Introduction:

Microvascular surgery has revolutionized the field of head and neck cancer reconstruction, offering patients the prospect of functional and aesthetic restoration following surgical resections. Among the array of available techniques, the radial artery forearm flap (FRAF), anterolateral thigh flap (ALT), and fibula osteocutaneous flap (FFOCF) have emerged as the foremost choices for reconstructive procedures. These free flaps offer versatility, reliability, and favourable outcomes, contributing to their widespread adoption as the cornerstone of contemporary reconstructive strategies.

The primary objectives of reconstructive surgery extend beyond mere anatomical restoration to encompass the restoration of critical functions such as speech and swallowing, pivotal for maintaining patients` overall quality of life. The remarkable success rates exceeding 95percent reported in numerous centres underscore the efficacy of free flap reconstruction in achieving these goals. (1-3) However, the multifactorial nature of postoperative quality of life necessitates understanding factors influencing patient outcomes beyond surgical success alone.

The influence of reconstruction type, surgical approach, cancer stage on postoperative quality of life cannot be overstated. (4) Complications such as primary and donor site morbidity and chronic postsurgical pain (CPSP) can significantly impact patients long-term well-being.

Recent studies have shed light on the prevalence and characteristics of donor site pain following reconstructive procedures, particularly with the anterolateral thigh flap (ALT). Shen et al (4), Townley et al. (5) and Weise et al. (6) have highlighted the persistence of pain and sensory disturbances at the donor site of ALT flap, emphasizing the need for thorough evaluation and proactive pain management strategies. Moreover, in a retrospective study, head and neck cancer pain has been linked to chronic opioid use, which in turn is associated with decreasing survival rates. (7) This finding underscores the intricate interplay between pain management, oncologic outcomes, and overall patient well being.

Poorly controlled acute pain can give rise to chronic pain. Chronic postsurgical pain (CPSP) is a complex clinical entity with profound implications for postoperative long term outcomes and quality of life. It persists beyond the normal healing period (3 months), and encompasses various dimensions of pain severity, distress, and interference with daily activities. (8)

To the best of our knowledge there is there is no literature evaluating the incidence of chronic pain at primary and donor site following head neck cancer surgery with free tissue transfer reconstruction.

Thus, we to study the incidence and severity of chronic postoperative pain at primary and donor site in patients undergoing free flap reconstruction for head and neck cancer.

Purpose:

The purpose of this study is to find the amount of pain in patients undergoing head, neck and plastic surgery. Pain scores on discharge and post operative day (day after the surgery) 30,60,180 will be noted. The pain killers used preoperatively, intraoperatively and postoperatively period will also be noted. In case if the pain is unbearable, we will refer the patient to the chronic pain services to take care of their pain and make them comfortable. No additional intervention will be done for the purpose of the study. On the day of discharge, we will also administer questionnaires to see the effect of pain and pain management techniques on quality of life and to understand the nature of pain.

This audit or study will help us to understand effectiveness of our current management and help us further improve the quality of care delivered.  We will record the necessary information from patients file, charts and electronic medical record and contact through telecommunication, WhatsApp, messages, and if possible assess physically.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 90.00 Year(s)(—)
性别
All

入选标准

  • All adult more than 18 years of age patients undergoing head and neck surgery with free flap reconstruction.

排除标准

  • Age less than 18 years Pregnant and Lactating women.

结局指标

主要结局

Incidence and severity of chronic postoperative pain in patients undergoing

时间窗: at 6 months post hospital discharge

free flap reconstruction for head and neck cancer.

时间窗: at 6 months post hospital discharge

次要结局

  • Nature of pain (Somatic/neuropathic) based on patients’ description(Incidence of Neuropathic pain (Pain Detect score).)

研究者

申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Vandana Agarwal

Tata Memorial Hospital

研究点 (1)

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