Study to identify the best anesthetic therapy for the control of postoperative pain after videothoracoscopic thoracic surgery
| ISRCTN | ISRCTN12771155 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12771155 |
| Secondary identifying numbers | ID1 |
- Submission date
- 29/12/2016
- Registration date
- 30/12/2016
- Last edited
- 15/04/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Plain English summary of protocol
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 levobupivacaine (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 Silvia González Santos, dra_sgsantos@yahoo.es
Contact information
Public
Anaesthesia and Resuscitation Department
Donostia University Hospital
Paseo Dr. Beguiristain s/n 20014
Donostia
20014
Spain
| Phone | +34 943007000 (Ext. 3670) |
|---|---|
| dra_sgsantos@yahoo.es |
Study information
| Study design | Single-centre randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Analgesic Efficacy of Intradural Morphine Versus Intercostal Block in the postoperative period of major pulmonary resection by videothoracoscopy |
| Study acronym | AEIMVIB |
| Study objectives | Intradural morphine is more effective in pain control than intercostal block in the postoperative period of major resection by videothoracoscopy. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Pain control after videothoracoscopic major resection |
| Intervention | Current intervention as of 15/02/2022: Participants are randomised to one of two groups using opaque envelopes. Control group: Participants receive an intercostal block with Levobupivacaine 0.5%, 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 <1.60 m and <60 kg, 200 mcg if height between 1.60 and 1.80 m and weight between 60 and 100 kg and 250 mcg, if height >1.80 m and weight >100 kg) Participants in both groups are followed up for a total of 12 months. _____ Previous intervention as of 03/02/2022: Participants are randomised to one of two groups using opaque envelopes. Control group: Participants receive an intercostal block with Levobupivacaine 0.5%, 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 m and weight >100 kg) Participants in both groups are followed up for a total of 12 months. _____ Previous 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 | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Morphine, levobupivacaine |
| Primary outcome measure | Pain at rest and with cough (0 h, 6 h, 12 h, 24 h, 48 h, 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 study start date | 01/12/2015 |
| Completion date | 28/02/2019 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 120-140 |
| Total final enrolment | 181 |
| Key inclusion criteria | 1. Undergoing to lung resection (lobectomies, bilobectomies, or segmentectomies) by videothoracoscopy 2. Age 18 years and over |
| Key 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 |
| Date of first enrolment | 01/12/2017 |
| Date of final enrolment | 15/04/2020 |
Locations
Countries of recruitment
- Spain
Study participating centre
Donostia
20014
Spain
Sponsor information
Hospital/treatment centre
Paseo Beguiristain s/n
Donostia
20014
Spain
"ROR" |
https://ror.org/04fkwzm96 |
|---|
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | 31/12/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Planned publication in a peer reviewed journal. |
| IPD sharing plan | Not provided at registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Basic results | 07/04/2021 | 07/04/2021 | No | No | |
| Protocol file | version 4 | 22/08/2017 | 01/09/2022 | No | No |
| Results article | 28/03/2024 | 15/04/2024 | Yes | No |
Additional files
- ISRCTN12771155_BasicResults_07Apr2021.pdf
- Uploaded 07/04/2021
- 33019 PROTOCOL v4 22Aug2017.pdf
Editorial Notes
15/04/2024: Publication reference added.
01/09/2022: Uploaded protocol (not peer-reviewed) as an additional file.
15/02/2022: The intervention has been changed.
04/02/2022: The following changes have been made:
1. The public contact has been changed.
2. The intention to publish date has been changed from 01/09/2021 to 31/12/2022.
03/02/2022: The following changes have been made:
1. The intervention type has been changed from 'Procedure/surgery' to 'Drug'.
2. The drug names have been added.
3. The intervention has been updated and the plain English summary updated accordingly.
07/04/2021: A basic results summary has been added as an additional file.
06/04/2021: The following changes have been made:
1. The recruitment start date has been changed from 01/03/2017 to 01/12/2017.
2. The recruitment end date has been changed from 28/02/2018 to 15/04/2020.
3. The intention to publish date has been changed from 28/02/2020 to 01/09/2021.
4. The final enrolment number has been added.
