Plain English Summary
Background and study aims
After undergoing surgery, especially abdominal (belly) surgery, patients experience a decrease in their gut function that results in constipation, bloating, nausea and vomiting. The cause of this is still unclear but surgical manipulation of the gut, medical assessments, and medication given for pain control after surgery have been shown to contribute. This study explores the effect of different pain control regimes on the function of the gut following thoracic (lung) surgery. The aim of this study is to look at the effects of morphine delivered through a drip, local anaesthetics (numbing agents) delivered directly into the spine (epidural catheter) and a combination of the two techniques on gut function and pain after surgery.
Who can participate?
Adults aged 30-85 who are undergoing major thoracic surgery
What does the study involve?
One week before having surgery, all patients undergo two tests of gut function. The first involves measuring the time it takes for a substance to travel from the mouth to the beginning on the large intestine. In the second test, patients are asked to swallow 20 small plastic pellets that are visible by x-ray of their abdomen. They then have an x-ray four days later in order to measure how many of them are left in their large bowel, to give an indication of the time that the large bowel needs to empty. On the day of surgery, participants are randomly allocated to one of three groups. Participants receive surgery and surgical aftercare as normal. Those in the first group have a tube inserted into their spine through which numbing agents are delivered to provide pain relief. Those in the second group receive a combination of morphine (a strong pain killer) and a numbing agent through a drip. Those in the third group receive a combination of the techniques given to those in the first two groups. In the days following surgery, participants are asked to rate their pain levels and repeat the gut function tests taken one week before their surgery.
What are the possible benefits and risks of participating?
Participants benefit from being enrolled in a standardised recovery programme which could help enhance their recovery. There is a small risk of experiencing side-effects from the medications used in this study to control pain, such as low blood pressure, nausea and vomitting, drowsiness, or allergic reaction.
Where is the study run from?
University Hospital of Heraklion (Greece)
When is the study starting and how long is it expected to run for?
September 2001 to November 2009
Who is funding the study?
1. University Hosipital of Heraklion (Greece)
2. Investigator initiated and funded (Greece)
Who is the main contact?
Dr Argyro Zoumprouli
Argyro.Zoumprouli@stgeorges.nhs.uk
Trial website
Contact information
Type
Scientific
Primary contact
Dr Argyro Zoumprouli
ORCID ID
http://orcid.org/0000-0003-0890-690X
Contact details
St. George's University Hospitals NHS Foundation Trust
Tooting
London
SW17 0QT
United Kingdom
+44 (0)20 8672 4195
Argyro.Zoumprouli@stgeorges.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
3197
Study information
Scientific title
Gastrointestinal motility following thoracic surgery, the effect of thoracic epidural analgesia: a randomised controlled trial
Acronym
Study hypothesis
Epidural analgesia accelerates the postoperative gastrointestinal function compared with IV morphine following major thoracic surgery.
Ethics approval
Ethics committee of the University Hospital of Heraklion, 19/03/2002, ref: 3197
Study design
Single-centre unblinded three-arm randomised parallel trial
Primary study design
Interventional
Secondary study design
Randomised parallel trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet (in Greek)
Condition
Gastrointestinal motility after major thoracic surgery
Intervention
All patients have a standard preoperative assessment and received teaching on how to score pain and to report side effects. In addition, they are informed about postoperative tests, feeding and early ambulation, as well as postoperative visits from different teams. One hour before surgery, all patients receive premedication with intramuscular 0.07 mg.kg-1 midazolam. On arrival to the anaesthetic room, each patient is randomised by a computer-generated list of random numbers to one of three groups.
Group Ep-R: Participants receive a continuous epidural infusion of ropivacaine 0.2% (2 mg.ml-1) at a rate of 5-8 ml.h-1, with boluses of 2 ml of the same solution and a 20 min lockout interval via a PCA
Group Ep-RM: Participants receive a continuous epidural infusion of ropivacaine 0.15% (1.5 mg.ml-1) with morphine 0.05 mg.ml-1 at a rate of 5-7 ml.h-1, with boluses of 2 ml of the same solution and a 20 min lockout interval via a PCA
Group IV-M: Participants receive a continuous IV infusion of morphine of 1 mg.ml-1.h-1, with boluses of 0.5-1 mg and a 15 min lockout interval via a PCA
In groups Ep-R and Ep-RM before induction of general anaesthesia, a 20 G epidural catheter is inserted through an 18 G Tuohy needle between the T5-T9 levels using the loss of resistance technique and is threaded 3-5 cm into the epidural space.
Gastrointestinal motility is assessed for all participants by measuring orocaecal transit time (exhaled H2-lactulose test) and colonic transit time (radiopaque markers). Oro-cecal transit time (OCTT) is evaluated using the lactulose hydrogen (H2) breath test the first and third postoperative day. Colonic transit time (CTT) is evaluated by plain abdominal radiograph taken 4 days after the ingestion of 20 radiopaque markers. The indigestion of the markers takes place on the first postoperative morning. All patients participate in a standardised post-operative recovery regiment (early feeding, early ambulation).
Intervention type
Drug
Phase
Drug names
1. Ropivacaine
2. Morphine
Primary outcome measure
1. Oroceacal transit time is assessed using the lactulose H2 test on post-operative days 1 and 3
2. Colonic transit time is assessed by radiopaque markers and abdominal X-rays on post-operative day 4
Secondary outcome measures
Pain is measured using a visual analogue scale (VAS) on post-operative days 1 and 3
Overall trial start date
02/09/2001
Overall trial end date
10/11/2009
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Undergoing major thoracic surgery
2. Age 30-85 years
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
30 patients in total, 10 in each of three groups
Participant exclusion criteria
1. Diabetes mellitus
2. ASA physical status >III
3. History of chronic pain
4. Drug/alcohol dependance
5. Treatment with drugs known to affect GI motility
6. Inflammatory bowel disease
7. Previous bowel surgery
8. Morphine or local anaesthetic allergy
8. History of abdominal radiation
9. Contraindications to insertion of an epidural catheter
10. Severe renal or hepatic disease
Recruitment start date
20/03/2002
Recruitment end date
22/01/2009
Locations
Countries of recruitment
Greece
Trial participating centre
University Hospital of Heraklion
Voutes
Voutes
71500
Greece
Funders
Funder type
Hospital/treatment centre
Funder name
University Hospital of Heraklion
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Investigator initiated and funded
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned publication in a peer reviewed journal.
IPD Sharing plan:
The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Argyro Zoumprouli (Argyro.Zoumprouli@stgeorges.nhs.uk)
Intention to publish date
01/01/2018
Participant level data
Available on request
Basic results (scientific)
Publication list
2017 results in: https://www.ncbi.nlm.nih.gov/pubmed/29037157