Effects of thoracic analgesia on gastrointestinal motility

• Register: ISRCTN
• Last refreshed on: 20 November 2017
• Main ID: ISRCTN11953159
• Date of registration: 20/03/2017
• Prospective Registration: No
• Primary sponsor: University Hospital of Heraklion
• Public title: Effects of thoracic analgesia on gastrointestinal motility
• Scientific title: Gastrointestinal motility following thoracic surgery, the effect of thoracic epidural analgesia: a randomised controlled trial
• Date of first enrolment: 20/03/2002
• Target sample size: 30
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN11953159
• Study type: Interventional
• Study design: Single-centre unblinded three-arm randomised parallel trial (Treatment)

Countries of recruitment

Greece

Contacts

• Name: Argyro Zoumprouli

Key inclusion & exclusion criteria

Inclusion criteria: 1. Undergoing major thoracic surgery
2. Age 30-85 years
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

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Gastrointestinal motility after major thoracic surgery
Digestive System
Gastrointestinal motility after major thoracic surgery

Intervention(s)

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).

Primary Outcome(s)

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(s)

Pain is measured using a visual analogue scale (VAS) on post-operative days 1 and 3

Secondary ID(s)

3197

Source(s) of Monetary Support

University Hospital of Heraklion, Investigator initiated and funded