Effect of Ultra-Sound Guided Pre-emptive Nerve Block on Post-operative Pain Following Open Inguinal Hernia Repair: Randomised Control Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 136
- 主要终点
- Pain Scale (from 1 to 10) 1 is the minimum and 10 the maximum pain severity.
研究概览
简要总结
A hernia occurs when an organ 'like intestines' or fatty tissue protrude through a weak point in muscle or connective tissue and one of the most common types of hernia is inguinal. Inguinal hernia defined as a bulge in the inguinal region or scrotum, may be accompanied by dull or burning pain, which worsens by exercise or cough. There are 2 types of inguinal hernia: direct and indirect. Direct inguinal hernia occurs because of a defect or weakness in the transversalis fascia area of the Hesselbach triangle. On the other hand, the indirect inguinal hernia which is the most common inguinal hernia follows the tract of inguinal canal and result from a persistent processus vaginalis.
Immediate pain after inguinal herniorrhaphy delays the ambulation which leads to delay in the hospital discharge. Besides that, is the chronic pain that affect 50% of patients which is an important issue that needs to be dealt with.
Our aim of this study, is to compare between postoperative period in the patients who received US guided nerve block and in patients who received infiltration only before open inguinal hernia repair, and to show that pre-emptive local anaesthesia will result in better pain control, less postoperative complication, earlier mobilisation, earlier recovery and less analgesia consumption by patients.
详细描述
In this study our aim in detail is to:
- Asses the outcomes (early postoperative pain management in day case "day 1,2,3, 30 and 3 month and 6 month" , length of hospital stay, analgesia consumption، recovery to work, driving and usual activity) of the US guided nerve block in patients who underwent inguinal hernia repair comparing to patient who received only skin infiltration.
- Evaluate the advantages of the US guided nerve block in postoperative inguinal hernia repair patients.
- Demonstrate its compatibly as a one day procedure (less length of hospital stay), with earlier return to work and driving and recovery in general.
- Compare our result with other international studies result.
Study in details:
it is Randomised Control Trial, Double blinded (patients and recruiter), study will be conducted in King Fahd University Hospital, Khobar, Eastern Province, Saudi Arabia. It contains 2 Arms ,Two Parallel groups. The experimental group will receive US guided nerve block and the control group will receive usual infiltration. Lidocaine+ Marcaine will be used in both group with same concentration (1%+.25%). The random allocation will be done using simple random allocation with a help of the following software (random.org).
Will compare the two groups regarding, a questionary with visual analogue will be distributed and data will be collected by recruiters regarding pain scale, length of hospital stay, return to work, return to driving and usual activity, and analgesia consumption post operative, all in day 1,2,3,4,30,3 month and 6 month post operatives (details in outcome section).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Double blinded ( Patient and researcher recruiter)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Pain Scale (from 1 to 10) 1 is the minimum and 10 the maximum pain severity.
时间窗: 6 month postoperative for chronic pain.
Assessment of pain scale post operative, lower score mean a better outcome.
Assessment of early mobilisation.
时间窗: Day 3 postoperative period.
When the patient started to mobilise? assessed by monitoring the patients postoperative and record when he started to mobilise.
Retain to driving (how many days between surgery and patient back to dive)
时间窗: Postoperative period up to 8 weeks.
When the patient back to drive his car? assessed by monitoring the patients postoperative and record when he started to drive the car again.
Retain to work (how many days between surgery and patient back to his work)
时间窗: Postoperative period up to 8 weeks.
When the patient back to his work or usual activity? assessed by monitoring the patients postoperative and record when he started to work again.
Length of hospital stay (in days).
时间窗: immediately after the surgery until patient discharged.
Length of hospital stay post open inguinal hernia repair ( how many days patient spend in the hospital postoperative).
Frequency of analgesia consumption postoperative.
时间窗: Day 7 postoperative.
Analgesia consumption by patient postoperative (How frequent patient taking analgesia postoperative).
次要结局
未报告次要终点
研究者
Nasser Mohamed Amer
Assistant professor of General Surgery in Imam Abdulrahman bin Faisal University
Imam Abdulrahman Bin Faisal University