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

NCT07642674 | Recruiting

• 1 other identifier: Esogü95
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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

Conditions

Postoperative Pain; Pain Management; Rebound Pain; Interscalene Block

Keywords

Rebaund pain, Interscalene block, postoperative pain

Outcome Measures

Primary Outcomes (1)

• Effect of intravenous dexketoprofen administered during the postoperative period on the severity and incidence of rebound pain

  Rebound pain score(VAS ≥ 7) and incidence

  24 hours

Secondary Outcomes (2)

• Total opioid consumption

  24 hours

• Visual analog Scale

  24 hours

Study Arms (2)

Group K

PLACEBO COMPARATOR

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

Group D

ACTIVE COMPARATOR

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

Interventions

ISB + paracetamol IV 3*1 DRUG

ISB + paracetamol IV 3\*1

Group K

ISB+ paracetamol IV 3*1 +deksketoprofen IV 2*1 DRUG

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

Group D

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eskisehir Osmangazi University: lead

Study Sites (1)

Eskisehir Osmangazi Universıty Faculty of Medicine

Eskişehir, Odunpazarı, 26040, Turkey (Türkiye)

RECRUITING

Related Publications (3)

• Barry GS, Bailey JG, Sardinha J, Brousseau P, Uppal V. Factors associated with rebound pain after peripheral nerve block for ambulatory surgery. Br J Anaesth. 2021 Apr;126(4):862-871. doi: 10.1016/j.bja.2020.10.035. Epub 2020 Dec 31.

  PMID: 33390261 BACKGROUND

• Uppal V, Barry G, Ke JXC, Kwofie MK, Trenholm A, Khan M, Shephard A, Retter S, Shanthanna H. Reducing rebound pain severity after arthroscopic shoulder surgery under general anesthesia and interscalene block: a two-centre randomized controlled trial of pre-emptive opioid treatment compared with placebo. Can J Anaesth. 2024 Jun;71(6):773-783. doi: 10.1007/s12630-023-02594-0. Epub 2023 Oct 13.

  PMID: 37833472 BACKGROUND

• Singh NP, Makkar JK, Chawla JK, Sondekoppam RV, Singh PM. Prophylactic dexamethasone for rebound pain after peripheral nerve block in adult surgical patients: systematic review, meta-analysis, and trial sequential analysis of randomised controlled trials. Br J Anaesth. 2024 May;132(5):1112-1121. doi: 10.1016/j.bja.2023.09.022. Epub 2023 Oct 26.

  PMID: 38501226 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative; Agnosia

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Study Officials

• MERYEM ONAY

  Eskisehir Osmangazi University Faculty Of Medıcıne

  STUDY CHAIR

Central Study Contacts

Çağla Uzalp

CONTACT

02222392979; caglauzalp@gmail.com

Meryem Onay

CONTACT

02222392979; dr.meryemonay@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research assistant

Study Record Dates

• First Submitted: June 1, 2026
• First Posted: June 11, 2026
• Study Start: June 11, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: June 12, 2026

Record last verified: 2026-06

Locations

TU (1)