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The Effect of Intravenous Dexketoprofen on the Severity and Incidence of Rebound Pain

Evaluation of the Effect of Intravenous Dexketoprofen on the Severity and Incidence of Rebound Pain in Patients Undergoing Interscalene Brachial Plexus Block

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07642674
Enrollment
66
Registered
2026-06-11
Start date
2026-06-11
Completion date
2027-01-01
Last updated
2026-06-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Interscalene Block, Pain Management, Postoperative Pain, Rebound Pain

Keywords

Rebaund pain, Interscalene block, postoperative pain

Brief summary

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

Detailed description

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.

Interventions

DRUGISB + paracetamol IV 3*1

ISB + paracetamol IV 3\*1

DRUGISB+ paracetamol IV 3*1 +deksketoprofen IV 2*1

ISB+ paracetamol IV 3\*1 +deksketoprofen IV 2\*1. 25 miligram of dexketroprofen

Sponsors

Eskisehir Osmangazi University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

Age 18-70 years ASA score of I-III Arthroscopic shoulder surgery

Exclusion criteria

Patients who do not wish to participate in the study Creatinine clearance \<50 mL/ min Patients for whom NSAID use is contraindicated 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

Design outcomes

Primary

MeasureTime frameDescription
Effect of intravenous dexketoprofen administered during the postoperative period on the severity and incidence of rebound pain24 hoursRebound pain score(VAS ≥ 7) and incidence

Secondary

MeasureTime frameDescription
Total opioid consumption24 hoursTotal 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
Visual analog Scale24 hoursVisual analog scale at rest and movement (0 (no pain)-10 (unbearable pain))

Countries

Turkey (Türkiye)

Contacts

CONTACTÇağla Uzalp
caglauzalp@gmail.com02222392979
CONTACTMeryem Onay
dr.meryemonay@hotmail.com02222392979
STUDY_CHAIRMERYEM ONAY

Eskisehir Osmangazi University Faculty Of Medıcıne

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 13, 2026