An interventional study of ISB + paracetamol IV 3*1 and ISB+ paracetamol IV 3*1 +deksketoprofen IV 2*1 in Postoperative Pain, Pain Management and Rebound Pain, sponsored by Eskisehir Osmangazi University. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-06-12.
Sponsored by Eskisehir Osmangazi University · Not applicable, Interventional, and Prevention
Orthopedic shoulder surgeries are associated with severe postoperative pain, particularly within the first 24-48 hours after surgery. In postoperative pain management, single or continue interscalene brachial plexus blocks, acetaminophen, nonsteroidal anti-inflammatory drugs (NSAIDs), and opioids administered as needed are commonly used as components of multimodal analgesia.
Rebound pain is defined as severe postoperative pain (VAS ≥ 7) occurring within the first 24 hours after resolution of the block. It is considered an adverse effect of regional anesthesia and typically develops 8-12 hours after a single-shot nerve block. Risk factors for rebound pain include pre-existing pain, female sex, younger age, bone surgery, lack of intraoperative dexamethasone administration, and inadequate analgesia.
The primary objective of this study is to evaluate the effect of intravenous dexketoprofen administered during the postoperative period on the incidence and severity of rebound pain in patients undergoing shoulder surgery with interscalene brachial plexus block
Sixty-six patients undergoing rotator cuff repair will receive standardized ISB and general anesthesia for the surgery.All patients will be administered 0.03 mg/kg of midazolam during the preoperative period and an interscalene brachial plexus block will be administered using 10 cc of %0.5 bupivacaine and 5 ml of normal saline.During induction under general anesthesia, the following will be administered: lidocaine 1 mg/kg, propofol 2-3 mg/kg, rocuronium 0.6 mg/kg, and remifentanyl 0.5 mcg/kg. Maintenance of anesthesia will be provided using a mixture of %2-3 sevoflurane, %50 air, and %50 oxygen, maintaining the bispectral index between 40 and 50.
Heart rate and blood pressure values will be titrated by increasing or decreasing the remifentanil infusion to ensure that the values remain within %20 of baseline or that the OAB remains above 65.
If the mean arterial pressure drops by more than %20, 5 mg of ephedrine will be administered.
At the end of the procedure, the surgical duration and the total intraoperative remifentanil dose administered will be recorded.
In the postoperative recovery room, patients who show no loss of sensation in the C5-C6 dermatome (over the deltoid muscle) on the pinprick test but report severe pain (VAS ≥ 4) will be considered to have had a failed block.
Under the postoperative analgesia protocol all patients will be equipped with an IV morphine patient-controlled analgesia (PCA) device. The solution will be prepared such that morphine is 0.5 mg / ml. PCA 1mg bolus dose will be delivered with 10 min lock-out time and all patients will be administered 1 gram of paracetamol at 8th 16th and 24th hours.
Patients will be randomly divided into 2 groups as Group K(Patients not receiving nonsteroidal anti-inflammatory drugs) and Group D(Patients receiving nonsteroidal anti-inflammatory drugs) In Group D (Patients receiving nonsteroidal anti-inflammatory drugs) cases, will be administered 25 miligram of dexketroprofen at 6th and 18th hours.
In the postoperative period, a researcher assessed the patient's visual pain scores (resting and movement), rebound pain intensity, timing, and duration, systolic blood pressure, mean arterial pressure, diastolic blood pressure, peripheral oxygen saturation, postoperative analgesic consumption, and postoperative complications will be recorded.
Patient follow-up will be concluded at the end of 24 hours.
5,640 studies on the registry are indexed under Pain, Postoperative; 1,230 are open to participants now.
This study's planned enrollment of 66 is below the median of 75 across 4,821 interventional studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →Eskisehir Osmangazi University is the lead sponsor of 153 studies on the registry; 27 are open to participants now.
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Age 18-70 years of I-III Arthroscopic shoulder surgery
Exclusion Criteria:
Patients who do not wish to participate in the study \<50 mL/ min Patients for whom NSAID use is due to heart failure, Patients with psychiatric or cognitive dysfunction that would impair their ability to assess visual analog scale (VAS) pain scores Patients for whom peripheral nerve block is contraindicated
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.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
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.
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.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
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.
Under the postoperative analgesia protocol all patients will be administered 1 gr of paracetamol at 8th 16th and 24th hours and all patients will be equipped with an IV morphine patient-controlled analgesia (PCA) device.
Drug: ISB + paracetamol IV 3*1
Under the postoperative analgesia protocol all patients will be administered 1 gram of paracetamol at 8th 16th and 24th hours and all patients receiving nonsteroidal anti-inflammatory drugs (25 miligram of dexketroprofen) at 6th and 18th hours. The patients will be equipped with an IV morphine patient-controlled analgesia (PCA) device.
Drug: ISB+ paracetamol IV 3*1 +deksketoprofen IV 2*1
ISB + paracetamol IV 3\*1
ISB+ paracetamol IV 3\*1 +deksketoprofen IV 2\*1. 25 miligram of dexketroprofen
Effect of intravenous dexketoprofen administered during the postoperative period on the severity and incidence of rebound pain
Rebound pain score(VAS ≥ 7) and incidence
Time frame: 24 hours
Total opioid consumption
Total morphine patient control analgesia prepared 0.5 mg / ml. PCA 1 mg bolus dose will be delivered with 10 min lock-out time. Follow up morphine consumption at postoperative 24 hours
Time frame: 24 hours
Visual analog Scale
Visual analog scale at rest and movement (0 (no pain)-10 (unbearable pain))
Time frame: 24 hours
Plan to share: Undecided
Started Jun 2026 (actual). Primary completion is estimated for Jan 2027, 6 months after the start.
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 planned 6 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.
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