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A Study Investigating Pain Following Single-port or Multi-port Video Assisted Thoracoscopic Surgery (SiMuPort)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02556970
Recruitment Status : Withdrawn (Study never started and was abandoned.)
First Posted : September 22, 2015
Last Update Posted : November 15, 2016
Sponsor:
Collaborator:
David Telling Charitable Trust
Information provided by (Responsible Party):
University Hospitals Bristol NHS Foundation Trust

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Pain, Postoperative Procedure: Single port VATS Drug: Paracetamol Drug: Diclofenac Device: Camera (5mm diameter 30 degree videothoracoscope) Device: Forceps grasper Drug: 0.25% Levobupivicaine intercostal nerve block Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomised Multi-centre Feasibility Study Investigating Post-operative Pain Following Single-port or Multi-port Video Assisted Thoracoscopic Surgical (VATS) Procedures
Actual Primary Completion Date : September 2015

Arm Intervention/treatment
Experimental: 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.

Procedure: Single port VATS
Performing video-assisted thorascopic surgery through a single port

Drug: Paracetamol
1g intraoperatively
Other Name: Acetaminophen

Drug: Diclofenac
75mg intraoperatively
Other Name: Voltarol

Device: Camera (5mm diameter 30 degree videothoracoscope)
Device: Forceps grasper
Drug: 0.25% Levobupivicaine intercostal nerve block
Multi-level intercostal blocks will be placed subpleurally under thorascopic visualisation.
Other Name: 0.25% Chirocaine

Active Comparator: 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.
Drug: Paracetamol
1g intraoperatively
Other Name: Acetaminophen

Drug: Diclofenac
75mg intraoperatively
Other Name: Voltarol

Device: Camera (5mm diameter 30 degree videothoracoscope)
Device: Forceps grasper
Drug: 0.25% Levobupivicaine intercostal nerve block
Multi-level intercostal blocks will be placed subpleurally under thorascopic visualisation.
Other Name: 0.25% Chirocaine




Primary Outcome Measures :
  1. Ability to randomise 40 patients into trial [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. Median postoperative Visual Analogue Scale (VAS) pain score [ Time Frame: Before discharge (24-48 hours) ]
    VAS pain score; 0 = no pain, 10 = worst pain participant could imagine

  2. Maximum post operative Visual Analogue Scale (VAS) pain score [ Time Frame: Before discharge (24-48 hours) ]
    VAS pain score; 0 = no pain, 10 = worst pain participant could imagine

  3. Mean Visual Analogue Scale (VAS) pain score at 1 hour [ Time Frame: 1 hour after surgery ]
    VAS pain score; 0 = no pain, 10 = worst pain participant could imagine

  4. Mean Visual Analogue Scale (VAS) pain score at 24 hours [ Time Frame: At 24 hours after surgery ]
    VAS pain score; 0 = no pain, 10 = worst pain participant could imagine

  5. Crossover after randomisation [ Time Frame: During surgery (normal surgical time is approximately 1 hour) ]
    Proportion of the trial (single port) arm converted to multiple port thoracoscopic or open approaches after randomisation

  6. Total post-operative morphine consumption (mg) [ Time Frame: In the first 24 hours post-surgery ]
    Total morphine dose in milligrams

  7. Mortality [ Time Frame: 30 days post-surgery ]
  8. Unexpected ICU admission [ Time Frame: After surgery and before discharge (expected to be with in 48 hours) ]
  9. Hospital readmission rate [ Time Frame: Within 30 days of surgery ]
    Readmission for any complication of the thoracic surgery.

  10. Surgical site infection [ Time Frame: Within 30 days of surgery ]
    Diagnosed infection in or around the surgical incisions.

  11. Change in Quality of Life score [ Time Frame: Performed pre-operatively and at 30 days after surgery ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02556970


Sponsors and Collaborators
University Hospitals Bristol NHS Foundation Trust
David Telling Charitable Trust
Investigators
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Principal Investigator: Rebecca A Leslie, BM BS University Hospitals Bristol NHS Foundation Trust
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Responsible Party: University Hospitals Bristol NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT02556970    
Other Study ID Numbers: SU/2014/4744
First Posted: September 22, 2015    Key Record Dates
Last Update Posted: November 15, 2016
Last Verified: November 2016
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Acetaminophen
Diclofenac
Levobupivacaine
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anesthetics, Local
Anesthetics
Central Nervous System Depressants