An interventional study of Bupivacaine and Saline in Postoperative Analgesia, Pain, Postoperative and Opioid Consumption, sponsored by Ataturk University. Completed at 1 site in Turkey. Open to female participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2017-11-14.
Sponsored by Ataturk University · Not applicable, Interventional, and Treatment
Breast cancer is the most common type of cancer in women. Mastectomy and axillary lymph node disection are commonly performed as part of the cancer management. This surgery can cause significant postoperative pain. The serratus plane block (SPB) has been described for analgesia of the hemithorax and reported for many cases such as thoracoscopy, shoulder arthroscopy, breast surgery and axillary lymph node dissections. Serratus plane block may be a viable alternative to current regional anaesthetic techniques such as thoracic paravertebral and central neuraxial blockade.
The aim of this study is to determine effectiveness of ultrasound guided superficial serratus plane block in patients undergoing modified radical mastectomy and axillary lymph node dissection surgery.
5,640 studies on the registry are indexed under Pain, Postoperative; 1,230 are open to participants now.
This study's enrollment of 48 is below the median of 75 across 4,821 interventional studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →Ataturk University is the lead sponsor of 458 studies on the registry; 124 are open to participants now.
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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.
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.
Ultrasound guided serratus plane block with 30 ml %0,25 bupivacaine
Drug: Bupivacaine · Device: Ultrasound
Ultrasound guided sham block with 2 ml saline subcutaneously
Drug: Saline · Device: Ultrasound
30 ml %0,25 bupivacaine
2 ml saline subcutaneously
Ultrasound guided block
Opioid Consumption
First 24 hours total fentanyl consumption with patient controlled analgesia
Time frame: First 24 hours total opioid consumption
Visual analog pain score
Post operative pain will be evaluated with a Visual Analogue Scale (VAS) score of 0-10 (0= no pain and 10= worst imaginable pain) at first hour postoperatively.
Time frame: postoperative first hour
Visual analog pain score
Post operative pain will be evaluated with a Visual Analogue Scale (VAS) score of 0-10 (0= no pain and 10= worst imaginable pain) at second hour postoperatively.
Time frame: postoperative second hour
Visual analog pain score
Post operative pain will be evaluated with a Visual Analogue Scale (VAS) score of 0-10 (0= no pain and 10= worst imaginable pain) at 4th hour postoperatively.
Time frame: postoperative 4th hour
Visual analog pain score
Post operative pain will be evaluated with a Visual Analogue Scale (VAS) score of 0-10 (0= no pain and 10= worst imaginable pain) at 8th hour postoperatively.
Time frame: postoperative 8th hour
Visual analog pain score
Post operative pain will be evaluated with a Visual Analogue Scale (VAS) score of 0-10 (0= no pain and 10= worst imaginable pain) at 12th hour postoperatively.
Time frame: postoperative 12th hour
Visual analog pain score
Post operative pain will be evaluated with a Visual Analogue Scale (VAS) score of 0-10 (0= no pain and 10= worst imaginable pain) at 24th hour postoperatively.
Time frame: postoperative 24th hour
Plan to share: Undecided
Ran from Nov 2016 to primary completion in Mar 2017, 4 months.
Of 2,089 non-industry interventional studies with no phase under Pain, Postoperative, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 23. This study's 4 months is below that.
Counting every sponsor, half of 2,102 studies reached it within 11 months; a quarter within 6 and three quarters within 23.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Bupivacaine