A Phase 2/3 interventional study of Lidocaine Iv and Dexmedetomidine in Hysterectomy and Myomectomy, sponsored by University of Athens. Status unknown at 1 site in Greece. Open to female participants aged 30 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-12-08.
Sponsored by University of Athens · Phase 2/3, Interventional, and Prevention
Postoperative pain continues to be inadequately managed and is the most common reason for the delay in discharge and unplanned hospital admission after surgery. Opioids remain the mainstay for postoperative analgesia. However, there is a continuous search for adjuvant therapies to reduce the doses of opioids and their related adverse effects, and extend the use of non-opioid analgesia for acute pain after abdominal surgery, thereby improving patient recovery. Currently there are no clinical trials that investigate the effect of intravenous lidocaine vs dexmedetomidine on postoperative pain, analgesic consumption and bowel function of patients undergoing abdominal gynaecological surgery. Purpose of this prospective double blind randomised clinical trial is the investigation of the effect of perioperative intravenous infusion of lidocaine vs dexmedetomidine vs placebo (Normal Saline 0,9%) on analgesic parameters and functional recovery of patients undergoing abdominal gynaecological surgery.
5,640 studies on the registry are indexed under Pain, Postoperative; 1,230 are open to participants now.
This study's planned enrollment of 60 is below the median of 75 across 4,821 interventional studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →University of Athens is the lead sponsor of 139 studies on the registry; 19 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Lidocaine Iv
Drug: Dexmedetomidine
Drug: Normal saline
Lidocaine Iv
dexmedetomidine iv
placebo
analgesic consumption 24 hours postop
morphine consumption from PCA
Time frame: 24 hours postoperatively
postoperative pain
Numeric Pain Rating Scale- NPRS scale (0:no pain 10:worst pain ever)
Time frame: 0 hours postoperatively
postoperative pain
Numeric Pain Rating Scale- NPRS scale (0:no pain 10:worst pain ever)
Time frame: 2 hours postoperatively
postoperative pain
Numeric Pain Rating Scale- NPRS scale (0:no pain 10:worst pain ever)
Time frame: 4 hours postoperatively
postoperative pain
Numeric Pain Rating Scale- NPRS scale (0:no pain 10:worst pain ever)
Time frame: 8 hours postoperatively
postoperative pain
Numeric Pain Rating Scale- NPRS scale (0:no pain 10:worst pain ever)
Time frame: 24 hours postoperatively
postoperative pain
Numeric Pain Rating Scale- NPRS scale (0:no pain 10:worst pain ever)
Time frame: 48 hours postoperatively
Plan to share: No
Started Nov 2017 (actual). Primary completion is estimated for Nov 2018, 12 months after the start.
Of 49 non-industry phase 2/3 interventional studies under Pain, Postoperative, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 41. This study's planned 12 months is below that.
Counting every sponsor, half of 52 studies reached it within 17 months; a quarter within 10 and three quarters within 41.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Dec 2017. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Lidocaine · Dexmedetomidine