Determine which anaesthetic technique (general anaesthesia in combination with TAP blockade versus general anaesthesia in combination with thoracic epidural analgesia)offers the most benefits, with respect to attenuation of the surgical inflammatory…
ID
Source
Brief title
Condition
- Reproductive neoplasms female malignant and unspecified
- Uterine, pelvic and broad ligament disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Levels of cytokines (pro- and anti-inflammatory), procalcitonin, NLR and
C-reactive protein
Secondary outcome
1) Intensity of wound pain at rest and during movement by Numeric Rating Scale
2) The number of milligrams of opioids and NSAID consumed by the patient.
3) Health-related quality of life (HR-QOL) will be determined by EuroQol
instrument (EQ-5D).
4) Side effects such arrhythmias, hemodynamic changes and post epidural
headache will be registered and recorded as absent or present.
5) Length of hospital stay will be calculated and expressed in number of days.
Background summary
Evidence is growing that inflammation plays an important role in cancer
evolution. There is also growing appreciation that surgery, and the
accompanying inflammatory stress response, might induce immunosuppression
through which cancer cells are promoted to grow and metastasize. Although
opioids are traditionally used to attenuate the surgical inflammatory stress
response, there is also evidence that opioids might paradoxically induce
further immunosuppression and thereby promote cancer growth. Neuraxial blockade
has been shown to attenuate the stress response, thereby preserving immunity.
Adjuvant loco-regional techniques, like for instance Transverse Abdominal Plane
(TAP) blockade, are increasingly used to decrease the need for opioids and to
preserve immunity as much as possible. However, in case of laparoscopic
hysterectomy, there is lack of evidence indicating which adjuvant type of
analgesia most effectively attenuates pain and the stress response. The aim of
this study is to determine which anaesthetic technique (general anaesthesia in
combination with TAP blockade versus general anaesthesia in combination with
thoracic epidural analgesia offers the most benefits, with respect to
attenuation of the surgical inflammatory stress response
Study objective
Determine which anaesthetic technique (general anaesthesia in combination with
TAP blockade versus general anaesthesia in combination with thoracic epidural
analgesia)offers the most benefits, with respect to attenuation of the surgical
inflammatory stress response, pain intensity and Health-related quality of life
(HR-QOL).
Study design
Prospective longitudinal study of six month for changes in cytokine
concentrations before and after surgery.
Study burden and risks
Not applicable
plesmanlaan 121
Amsterdam 1066CX
NL
plesmanlaan 121
Amsterdam 1066CX
NL
Listed location countries
Age
Inclusion criteria
* Patients scheduled for elective laparoscopic hysterectomy, laparoscopic staging procedures, laparoscopic radical hysterectomy.
* Adult patients (older than 18 years of age)
* Written informed consent
* Understanding of Dutch or English language
Exclusion criteria
* Non-elective surgery
* Any contraindication to neuraxial blockade (including coagulopathy, abnormal anatomy)
* Allergy to amide-linked local anaesthetics, especially bupivacaine
* Known psychiatric disorder
* Chronic pain patients or patients already using morphine pre-operatively
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL55841.031.16 |