Condition category
Surgery
Date applied
29/12/2016
Date assigned
30/12/2016
Last edited
30/12/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
A lung resection is a type of surgical procedure where part of the lung (or lungs) is removed. This is a common procedure in patients suffering from lung cancer, as it allows for the cancerous tissue to be removed, preventing the cancer from spreading. In some cases, this is done using a technique called a video thoracoscopy, in which a small camera on the end of a flexible tube is inserted into the surgical wound so that the surgeon can accurately see what they are doing during the procedure. This helps to improve accuracy only the necessary amount of tissue is removed. When patients are having this procedure, they usually also have an injection of a steroid or other medication around the intercostal nerves that are found under each rib (thoracic intecostal block) to provide pain relief. The intradural morphine block, also known as spinal anaesthesia, is another kind of pain relieving injection which is much less commonly used in lung surgery patients. It involves receiving an injection of morphine into the spine to provide pain relief. The aim of this study is to compare the effectiveness of these two techniques in providing pain relief during and after lung resection via video thoracoscopy.

Who can participate?
Adults who are undergoing lung resection via video thoracoscopy.

What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group receive an intercostal block with a drug called ropivacaine (a numbing medicine) before their surgery. Those in the second group receive intradural morphine (a pain relieving drug) into the spine before their surgery. All participants undergo their lung resection surgery as per standard practice and are monitored for side effects during and after their surgery. Participants in both groups are asked to rate their pain levels at the start of the study, 6, 12, 24 and 48 hours later, and then 6 and 12 months later.

What are the possible benefits and risks of participating?
There are no direct benefits involved with participating. Since both techniques are routinely used, participants will not be at greater risk than usual clinical practice.

Where is the study run from?
Donostia University Hospital (Spain)

When is the study starting and how long is it expected to run for?
December 2015 to February 2019

Who is funding the study?
Donostia University Hospital (Spain)

Who is the main contact?
Dr Borja Aguinagalde
borja.aguinagaldevaliente@osakidetza.net

Trial website

Contact information

Type

Public

Primary contact

Dr Borja Aguinagalde

ORCID ID

Contact details

Donostia University Hospital
Paseo Beguiristain s/n
Donostia
20014
Spain
+34 627 439 590
borja.aguinagaldevaliente@osakidetza.net

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

ID1

Study information

Scientific title

Analgesic Efficacy of Intradural Morphine Versus Intercostal Block in the postoperative period of major pulmonary resection by videothoracoscopy

Acronym

AEIMVIB

Study hypothesis

Intradural morphine is more effective in pain control than intercostal block in the postoperative period of major resection by videothoracoscopy.

Ethics approval

Not provided at time of registration

Study design

Single-centre randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Pain control after videothoracoscopic major resection

Intervention

Participants are randomised to one of two groups using opaque envelopes.

Control group: Participants receive an intercostal block with 0.75% Ropivacaine (maximum dose 225mg) with infiltration at the level of the upper incision and two upper and lower spaces

Intervention group: Participants receive intradural morphine at the L2-L3 or L3-L4 level, with the administration of morphic chloride (150 mcg if the patient measures <1.50 m and <60 kg, 200 mcg if height between 1.50 and 1.80 m and weight between 60 and 100 kg and 250 mcg, if height> 1.80 and weight> 100 kg)

Participants in both groups are followed up for a total of 12 months.

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measures

Pain at rest and with cough (0h, 6h, 12h, 24h, 48h, 6 months and 12 months)

Secondary outcome measures

1. Sedation is measured using the Richmond agitation sedation scale 24 hours after surgery
2. Nausea or vomiting is measured by patient interview and medical and nursery record review 24 and 48 hours after surgery
3. Pruritus is measured by patient interview and medical and nursery record review 24 and 48 hours after surgery
4. General satisfaction of pain management is measured by patient interview at the time of discharge
5. Respiratory complications (atelectasis requiring BCF, pneumonia requiring antibiotic, respiratory insufficiency requiring TBI) are measured by patient interview and medical record review during postoperative days
6. Cardiac complications (ACxFA, AMI, ICC) are measured by by patient interview and medical record review during postoperative days
7. Urinary retention with resondation or impossibility of urinary catheter extraction is assessed by patient interview and medical record review during postoperative days
8. Days to ambulation is measured by patient interview and medical and nursery record review during postoperative days
9. Mortality is measured using medical record review at 90 days

Overall trial start date

01/12/2015

Overall trial end date

28/02/2019

Reason abandoned

Eligibility

Participant inclusion criteria

1. Undergoing to lung resection (lobectomies, bilobectomies, or segmentectomies) by videothoracoscopy
2. Age 18 years and over

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

120-140

Participant exclusion criteria

1. Age <18 years
2. History of drug abuse
3. Patients with chronic pain treated with opioids
4. Any contraindication for the accomplishment of intradural or intercostal block (hemorrhagic diseases, recent systemic or local infections, allergy to local anesthetics or morphine, CNS expansive processes, hydrocephalus or alterations of the lumbar spine that contraindicate the lumbar puncture)
5. Patients who do not want to participate or mentally not competent
6. Surgeries converted to thoracotomy

Recruitment start date

01/03/2017

Recruitment end date

28/02/2018

Locations

Countries of recruitment

Spain

Trial participating centre

Donostia University Hospital
Paseo Beguiristain s/n.
Donostia
20014
Spain

Sponsor information

Organisation

Donostia University Hospital

Sponsor details

Paseo Beguiristain s/n
Donostia
20014
Spain

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

Donostia University Hospital

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a peer reviewed journal.

Intention to publish date

28/02/2020

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes