A Randomised Multi-centre Feasibility Study Investigating Post-operative Pain Following Single-port or Multi-port Video Assisted Thoracoscopic Surgical (VATS) Procedures
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Ability to randomise 40 patients into trial
研究概览
简要总结
This study seeks to establish if thoracoscopic surgery performed through a single port or incision reduces early post-operative pain compared with conventional multiple port thoracoscopic surgery.
This initial pilot study is designed to establish whether a trial of the two techniques is acceptable to patients, clinically feasible and can be delivered in a reasonable timescale.
详细描述
This is a patient- and assessor-blinded, multi-centre randomised trial with two groups (n=20 in each arm). Patients referred to Universities Hospital Bristol NHS Foundation Trust (n=20) and Liverpool Heart and Chest Hospital NHS Foundation Trust (n=20) requiring elective VATS lung surgery.
Patients will be identified and recruited by the thoracic surgeons in their surgical outpatient clinic. Participants will receive verbal and written information about the two different surgical techniques.
Consent will be sought by one of the surgical research nurses in the surgical outpatient clinic after the thoracic surgeon has recruited them. On the rare occasion that this is not possible, consent will occur in the pre-operative assessment clinic (POAC) at a later date. All patients are seen in POAC at least 1 week prior to surgery except in extreme circumstances. In POAC consent will also be sought by one of the surgical research nurses.
Participants will be given contact details for the study team should they have any questions between consent and surgery. They will be able to withdraw consent at any time prior to surgery.
All data will be entered into a Trust-based computer that is password protected. Subject names will be kept on a database and will be linked only with a study identification number for this research. There will be no patient identifiers. Only the research team will have access to this computer. Data will be stored in a locked office and maintained for a minimum of five years after the completion of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects will be recruited from patients requiring VATS for elective lung, lymph node or mediastinal biopsies or wedge resections of pulmonary nodules.
- •Technically suitable for both single port or multiport approaches in the opinion of the recruiting surgeon.
- •ASA 1,2 or 3.
排除标准
- •Pregnancy or breastfeeding.
- •Patient refusal.
- •Emergency surgery.
- •Patient unable to provide consent or complete the follow up.
- •Patients who attend a chronic pain clinic on high doses of opiate drugs.
- •History of Anaphylaxis/allergy to local anaesthetic.
- •Lobectomy patients.
研究组 & 干预措施
Single-port surgery
After induction of anaesthesia and lung isolation, a single intercostal incision will be placed laterally. This will usually be anterior to the border of the latissimus dorsi muscle, and in the 4th-7th space as appropriate to the planned surgery.
A soft tissue wound protector can be used to protect the wound edges, but rigid intercostal retraction is not permitted. All instruments will be placed via this incision.
干预措施: Single port VATS (Procedure)
Single-port surgery
After induction of anaesthesia and lung isolation, a single intercostal incision will be placed laterally. This will usually be anterior to the border of the latissimus dorsi muscle, and in the 4th-7th space as appropriate to the planned surgery.
A soft tissue wound protector can be used to protect the wound edges, but rigid intercostal retraction is not permitted. All instruments will be placed via this incision.
干预措施: Paracetamol (Drug)
Single-port surgery
After induction of anaesthesia and lung isolation, a single intercostal incision will be placed laterally. This will usually be anterior to the border of the latissimus dorsi muscle, and in the 4th-7th space as appropriate to the planned surgery.
A soft tissue wound protector can be used to protect the wound edges, but rigid intercostal retraction is not permitted. All instruments will be placed via this incision.
干预措施: Diclofenac (Drug)
Single-port surgery
After induction of anaesthesia and lung isolation, a single intercostal incision will be placed laterally. This will usually be anterior to the border of the latissimus dorsi muscle, and in the 4th-7th space as appropriate to the planned surgery.
A soft tissue wound protector can be used to protect the wound edges, but rigid intercostal retraction is not permitted. All instruments will be placed via this incision.
干预措施: Camera (5mm diameter 30 degree videothoracoscope) (Device)
Single-port surgery
After induction of anaesthesia and lung isolation, a single intercostal incision will be placed laterally. This will usually be anterior to the border of the latissimus dorsi muscle, and in the 4th-7th space as appropriate to the planned surgery.
A soft tissue wound protector can be used to protect the wound edges, but rigid intercostal retraction is not permitted. All instruments will be placed via this incision.
干预措施: Forceps grasper (Device)
Single-port surgery
After induction of anaesthesia and lung isolation, a single intercostal incision will be placed laterally. This will usually be anterior to the border of the latissimus dorsi muscle, and in the 4th-7th space as appropriate to the planned surgery.
A soft tissue wound protector can be used to protect the wound edges, but rigid intercostal retraction is not permitted. All instruments will be placed via this incision.
干预措施: 0.25% Levobupivicaine intercostal nerve block (Drug)
Multiple port surgery
Patients in this arm will have 3 separate incisions placed to site the camera and other instruments. This will involve three separate incisions.
干预措施: Paracetamol (Drug)
Multiple port surgery
Patients in this arm will have 3 separate incisions placed to site the camera and other instruments. This will involve three separate incisions.
干预措施: Diclofenac (Drug)
Multiple port surgery
Patients in this arm will have 3 separate incisions placed to site the camera and other instruments. This will involve three separate incisions.
干预措施: Camera (5mm diameter 30 degree videothoracoscope) (Device)
Multiple port surgery
Patients in this arm will have 3 separate incisions placed to site the camera and other instruments. This will involve three separate incisions.
干预措施: Forceps grasper (Device)
Multiple port surgery
Patients in this arm will have 3 separate incisions placed to site the camera and other instruments. This will involve three separate incisions.
干预措施: 0.25% Levobupivicaine intercostal nerve block (Drug)
结局指标
主要结局
Ability to randomise 40 patients into trial
时间窗: 3 months
次要结局
- Median postoperative Visual Analogue Scale (VAS) pain score(Before discharge (24-48 hours))
- Maximum post operative Visual Analogue Scale (VAS) pain score(Before discharge (24-48 hours))
- Mean Visual Analogue Scale (VAS) pain score at 1 hour(1 hour after surgery)
- Mean Visual Analogue Scale (VAS) pain score at 24 hours(At 24 hours after surgery)
- Crossover after randomisation(During surgery (normal surgical time is approximately 1 hour))
- Total post-operative morphine consumption (mg)(In the first 24 hours post-surgery)
- Mortality(30 days post-surgery)
- Unexpected ICU admission(After surgery and before discharge (expected to be with in 48 hours))
- Hospital readmission rate(Within 30 days of surgery)
- Surgical site infection(Within 30 days of surgery)
- Change in Quality of Life score(Performed pre-operatively and at 30 days after surgery)