Hypothesis to be tested (null hypothesis) : A continuous epidural infusion of bupivacaïne/sufentanil is equal to bupivacaïne/morphine in patients undergoing major surgery in terms of analgesia and side effects The aim of the study is to compare the…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
pijnbehandeling
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
-The pain scores of the patient on the Numerical Rating Scale (NRS) during the
first
72 hours after surgery.
Secondary outcome
-Registration of side-effects: pruritus, nausea and vomiting.
-Registration of adverse effects: respiratory depression, sedation and motor
block.
-The quality of pain relief by the patient.
Background summary
Epidural analgesia is an effective method of pain relief after major
cardiothoracic, upper abdominal, urogenital and lower limb surgery. Continuous
epidural analgesia can be effectuated by different medication. There is no
evidence indicating the optimal medication or mixture. Frequently used mixtures
are bupivacaine with morphine, sufentanil or fentanyl. In our hospital we use
bupivacaïne 2,5 mg/ml with morphine 0.08 mg/ml, 4-8 ml/h. In a pilot study, we
have evaluated 448 consecutive patients treated with this mixture epidurally.
Twenty four hours after surgery 36% of the patients had moderate and severe
pain (VAS > 4), 12% had severe pain (VAS > 7), all measured on movement. 24.3%
of the 448 patients complained of nausea, 8% of these patients actually
vomited. Pruritus occurred in 29.5% of the patients. Compared to Brodner et
all3 and to Tuncel et al the presented pain scores are rather high and
side-effects are frequent. Therefore, the question arises whether the
postoperative care can be improved by replacing morphine into sufentanil.
Although many studies on postoperative pain have been performed, continuous
epidural bupivacaine with morphine or sufentanil have not been compared in a
large, prospective, randomised study.
Reference:
Kavanagh B, Katz J, Sandier A. Pain control after thoracic surgery. A review of
current techniques. Anesthesiology 1994; 81: 737-59.
Dijk van J. Continuous epidural analgesia with bupivacaïne and morphine after
major surgery in 2006: pain and side effects. Study not publiced.
Brodner G, Mertes N, Van Aken H, e.a. What concentration of sufentanil should
be combined with ropivacaine 0.2% wt/vol for postoperative patient-controlled
epidural analgesia? Anesthesia and Analgesia 2000; 90; 649-57.
Tuncel G, Ozalp G, Savli S, e.a. Epidural ropivacaine or sufentanil-ropivacaine
infusions for post-thoracotomy pain. European Journal of Cardio-thoracic
Surgery 2005; 28; 375-9.
Broekema A, Gielen M and Hennis P. Postoperative analgesia with continuous
epidural sufentanil and bupivacaïne: a prospective study in 614 patients.
Regional Anesthesia and Pain Management 1996; 82; 754-9.
Study objective
Hypothesis to be tested (null hypothesis) : A continuous epidural infusion of
bupivacaïne/sufentanil is equal to bupivacaïne/morphine in patients undergoing
major surgery in terms of analgesia and side effects
The aim of the study is to compare the analgesic efficacy and side-effects of a
continuous epidural infusion of bupivacaïne/sufentanil and bupivacaïne/morphine
mixture in patients undergoing major surgery.
Continuous epidural analgesia can be effectuated by different medication.
There is no evidence indicating the optimal medication or mixture.
In our hospital we use bupivacaine/morphine, other possible mixtures are
bupivacaine/sufenta or bupivacaine/fentanyl.
Theoretically bupivacaine/sufenta is probably the best choice and is the used
most elsewhere.
The purpose of this study is to compare the analgesic efficacy and side-effects
of a continuous epidural infusion of bupivacaïne/sufentanil or bupivacaïne/
morphine mixture in patients undergoing major surgery.
Study design
This study study is a monocenter, double-blinded, randomised controlled
clinical trial.
Intervention
Interventions: group BM: bupivacaïne 2.5 mg/ml + morphine 0.08 mg/ml
group BS: bupivacaïne 2.5 mg/ml + sufentanil 1 ug/ml
Study burden and risks
Not different from conventional treatment.
Heidelberglaan 100
3584 CX Utrecht
NL
Heidelberglaan 100
3584 CX Utrecht
NL
Listed location countries
Age
Inclusion criteria
All patients > - 18 years old, scheduled for major surgery and indicated for epidural catheter.
Exclusion criteria
No dutch speaking, mental disability, allergy to one of the study medications. Pregnancy.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
Register | ID |
---|---|
EudraCT | EUCTR2007-005275-33-NL |
CCMO | NL19432.041.09 |
OMON | NL-OMON22506 |