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

NCT02556970 | Withdrawn

• 1 other identifier: SU/2014/4744
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pain, Postoperative

Outcome Measures

Primary Outcomes (1)

• Ability to randomise 40 patients into trial

  3 months

Secondary Outcomes (11)

• 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)

Study Arms (2)

Single-port surgery

EXPERIMENTAL

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; Drug: Paracetamol; Drug: Diclofenac; Device: Camera (5mm diameter 30 degree videothoracoscope); Device: Forceps grasper; Drug: 0.25% Levobupivicaine intercostal nerve block

Multiple port surgery

ACTIVE COMPARATOR

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; Drug: Diclofenac; Device: Camera (5mm diameter 30 degree videothoracoscope); Device: Forceps grasper; Drug: 0.25% Levobupivicaine intercostal nerve block

Interventions

Single port VATS PROCEDURE

Performing video-assisted thorascopic surgery through a single port

Single-port surgery

Paracetamol DRUG

1g intraoperatively

Also known as: Acetaminophen

Multiple port surgery; Single-port surgery

Diclofenac DRUG

75mg intraoperatively

Also known as: Voltarol

Multiple port surgery; Single-port surgery

Camera (5mm diameter 30 degree videothoracoscope) DEVICE

Multiple port surgery; Single-port surgery

Forceps grasper DEVICE

Multiple port surgery; Single-port surgery

0.25% Levobupivicaine intercostal nerve block DRUG

Multi-level intercostal blocks will be placed subpleurally under thorascopic visualisation.

Also known as: 0.25% Chirocaine

Multiple port surgery; Single-port surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospitals Bristol and Weston NHS Foundation Trust: lead
• David Telling Charitable Trust: collaborator

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Acetaminophen; Diclofenac; Levobupivacaine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Bupivacaine

Study Officials

• Rebecca A Leslie, BM BS

  University Hospitals Bristol and Weston NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2015
• First Posted: September 22, 2015
• Primary Completion: September 1, 2015
• Last Updated: November 15, 2016

Record last verified: 2016-11