Condition category
Digestive System
Date applied
04/03/2017
Date assigned
20/03/2017
Last edited
19/10/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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 measures

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

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

Sponsor information

Organisation

University Hospital of Heraklion

Sponsor details

Anaesthesiology Department
Voutes
Heraklion
71500
Greece

Sponsor type

Hospital/treatment centre

Website

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

Results - basic reporting

Publication summary

2017 results in: https://www.ncbi.nlm.nih.gov/pubmed/29037157

Publication citations

Additional files

Editorial Notes

19/10/2017: Publication reference added.