NCT07666009

Brief Summary

Rebound pain after peripheral nerve blocks reduces the benefits of regional anesthesia and increases opioid consumption. This rebound pain most likely results from suboptimal pain management, as patients receiving a peripheral nerve block are typically not given scheduled opioid doses. Oral Patient Controlled Analgesia (PCA) consists of an oral morphine prescription that allows patients to self-administer doses based on their pain score. This study will compare patients undergoing elective orthopaedic surgery under general anaesthesia or sedation with a peripheral nerve block, receiving oral morphine PCA either with or without additional scheduled oral morphine doses.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
13mo left

Started Jun 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress13%
Jun 2026Sep 2027

Study Start

First participant enrolled

June 1, 2026

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

June 15, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 24, 2026

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2027

Last Updated

June 24, 2026

Status Verified

June 1, 2026

Enrollment Period

1.3 years

First QC Date

June 15, 2026

Last Update Submit

June 18, 2026

Conditions

Keywords

rebound painpostoperative painpain managementorthopaedic surgeryperipheral nerve block

Outcome Measures

Primary Outcomes (1)

  • Worst pain score during the first 24 hours after surgery

    Highest postoperative pain score during the first 24 hours after surgery, measured using a 0-10 Visual Analog Scale (VAS), where 0 indicates no pain and 10 indicates the worst pain imaginable

    24 hours postoperatively

Secondary Outcomes (14)

  • Minimal pain score during the first 12 hours after surgery

    12 hours postoperatively

  • Rebound pain score measured using the Visual Analog Scale (VAS)

    From surgery until 24 hours postoperatively

  • Rest and dynamic pain scores

    At 2, 12, 24, 36, 48, 60, and 72 hours after surgery

  • Incidence of severe pain

    From surgery through 3 months after surgery

  • Persistence of pain

    During the follow-up period from discharge till 4 weeks and 3 months

  • +9 more secondary outcomes

Study Arms (2)

Scheduled group

EXPERIMENTAL

Oral morphine administered at predefined regular intervals starting immediately after surgery, with additional access to oral PCA.

Drug: Morphine provided via oral PCA + morphine administered at a scheduled regimen

On-demand group

ACTIVE COMPARATOR

Oral morphine administered on demand via PCA.

Drug: Morphine provided via oral PCA

Interventions

Morphine will be administered according to a scheduled regimen (20mg slow release oral morphine at fixed 12-hour intervals), with additional oral PCA on demand for breakthrough pain (VAS \> 4), following the same bedside tablet procedure as in the control group. The maximum allowed dose through oral PCA will be 6 tablets (10mg each) per 24-hour period.

On-demand group

morphine will be administered according to a scheduled regimen (20mg slow-release oral morphine at fixed 12-hour intervals), with additional oral PCA on demand for breakthrough pain (VAS \> 4), following the same bedside tablet procedure as in the control group. The maximum allowed dose through oral PCA will be 6 tablets (10mg each) per 24-hour period.

Scheduled group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients scheduled for elective orthopaedic surgery on the upper limb
  • Patients scheduled for elective orthopaedic surgery on the lower limb.
  • Score ASA I-III; Patients aged over 18 years; Signed informed consent.
  • Surgery under general anaesthesia or under sedation

You may not qualify if:

  • Refusal or inability to understand the informed consent
  • Allergy to any of the following medications: ropivacaine, paracetamol, ibuprofen, ketorolac, morphine,sufentanil, ondansetron, or dexamethasone
  • Patients with long term opioid treatment
  • Bleeding diathesis
  • Neurological disorders of the operated limb
  • Known renal insufficiency (eGFR \<30 mL/min)
  • Known hepatic insufficiency (Child-Pugh class B or C);
  • Pregnant or breastfeeding women;
  • Alcohol dependence syndrome;
  • Patients under spinal anaesthesia;
  • Patients undergoing amputation procedures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHUV, Centre Hospitalier Vaudois

Lausanne, Canton of Vaud, 1000, Switzerland

Location

Related Publications (16)

  • Abdallah FW, Halpern SH, Aoyama K, Brull R. Will the Real Benefits of Single-Shot Interscalene Block Please Stand Up? A Systematic Review and Meta-Analysis. Anesth Analg. 2015 May;120(5):1114-1129. doi: 10.1213/ANE.0000000000000688.

    PMID: 25822923BACKGROUND
  • Wu CL, Badani S, Tedore TR. Peripheral nerve blocks for perioperative analgesia: das Kind mit dem Bade ausschutten...throwing the baby out with the bathwater? Br J Anaesth. 2025 Nov;135(5):1147-1150. doi: 10.1016/j.bja.2025.08.017. Epub 2025 Sep 22.

    PMID: 40987657BACKGROUND
  • Galos DK, Taormina DP, Crespo A, Ding DY, Sapienza A, Jain S, Tejwani NC. Does Brachial Plexus Blockade Result in Improved Pain Scores After Distal Radius Fracture Fixation? A Randomized Trial. Clin Orthop Relat Res. 2016 May;474(5):1247-54. doi: 10.1007/s11999-016-4735-1. Epub 2016 Feb 11.

    PMID: 26869374BACKGROUND
  • Makkar JK, Singh NP, Khurana BJK, Chawla JK, Singh PM. Efficacy of different routes of dexamethasone administration for preventing rebound pain following peripheral nerve blocks in adult surgical patients: a systematic review and network meta-analysis. Anaesthesia. 2025 Jun;80(6):704-712. doi: 10.1111/anae.16566. Epub 2025 Feb 10.

    PMID: 39929722BACKGROUND
  • Hamilton DL. Rebound pain: distinct pain phenomenon or nonentity? Br J Anaesth. 2021 Apr;126(4):761-763. doi: 10.1016/j.bja.2020.12.034. Epub 2021 Feb 5. No abstract available.

    PMID: 33551124BACKGROUND
  • Lavand'homme P. Rebound pain after regional anesthesia in the ambulatory patient. Curr Opin Anaesthesiol. 2018 Dec;31(6):679-684. doi: 10.1097/ACO.0000000000000651.

    PMID: 30124544BACKGROUND
  • Schubert AK, Wiesmann T, Volberg C, Riecke J, Schneider A, Wulf H, Dinges HC. Rebound pain and postoperative pain profile following brachial plexus block compared to general anaesthesia-An observational study. Acta Anaesthesiol Scand. 2023 Nov;67(10):1414-1422. doi: 10.1111/aas.14318. Epub 2023 Aug 29.

    PMID: 37642227BACKGROUND
  • Henningsen MJ, Sort R, Moller AM, Herling SF. Peripheral nerve block in ankle fracture surgery: a qualitative study of patients' experiences. Anaesthesia. 2018 Jan;73(1):49-58. doi: 10.1111/anae.14088. Epub 2017 Oct 19.

    PMID: 29052225BACKGROUND
  • Singla P, Ye Y, Elkassabany NM, Mariano ER. 'Pain as regional anaesthesia wears off' or 'rebound pain': what's in a name? Anaesthesia. 2025 Jun;80(6):607-611. doi: 10.1111/anae.16583. Epub 2025 Mar 3. No abstract available.

    PMID: 40032279BACKGROUND
  • 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: 33390261BACKGROUND
  • Touil N, Pavlopoulou A, Barbier O, Libouton X, Gruson D, Gala JL, Lavand'homme P. Factors associated with a reduction in the preventive effect of intravenous dexamethasone on rebound pain after axillary brachial plexus block. Br J Anaesth. 2025 Oct;135(4):1059-1066. doi: 10.1016/j.bja.2025.05.055. Epub 2025 Jul 22.

    PMID: 40701886BACKGROUND
  • Munoz-Leyva F, Cubillos J, Chin KJ. Managing rebound pain after regional anesthesia. Korean J Anesthesiol. 2020 Oct;73(5):372-383. doi: 10.4097/kja.20436. Epub 2020 Aug 10.

    PMID: 32773724BACKGROUND
  • Chung AR, Mather RV, Gutierrez R, Liu R, Leung CFA, Zhang M, Santa Cruz Mercado LA, Houle TT, Bittner EA, Purdon PL. Association of peripheral nerve blocks with increased postoperative pain and opioid use in orthopaedic surgery: a single-centre retrospective cohort study. Br J Anaesth. 2025 Nov;135(5):1286-1296. doi: 10.1016/j.bja.2025.05.030. Epub 2025 Jul 3.

    PMID: 40610285BACKGROUND
  • Holmberg A, Hassellund SS, Draegni T, Nordby A, Ottesen FS, Gulestol A, Raeder J. Analgesic effect of intravenous dexamethasone after volar plate surgery for distal radius fracture with brachial plexus block anaesthesia: a prospective, double-blind randomised clinical trial. Anaesthesia. 2020 Nov;75(11):1448-1460. doi: 10.1111/anae.15111. Epub 2020 May 30.

    PMID: 32472958BACKGROUND
  • Yang ZS, Lai HC, Jhou HJ, Chan WH, Chen PH. Rebound pain prevention after peripheral nerve block: A network meta-analysis comparing intravenous, perineural dexamethasone, and control. J Clin Anesth. 2024 Dec;99:111657. doi: 10.1016/j.jclinane.2024.111657. Epub 2024 Oct 24.

    PMID: 39454286BACKGROUND
  • Sunderland S, Yarnold CH, Head SJ, Osborn JA, Purssell A, Peel JK, Schwarz SK. Regional Versus General Anesthesia and the Incidence of Unplanned Health Care Resource Utilization for Postoperative Pain After Wrist Fracture Surgery: Results From a Retrospective Quality Improvement Project. Reg Anesth Pain Med. 2016 Jan-Feb;41(1):22-7. doi: 10.1097/AAP.0000000000000325.

    PMID: 26650425BACKGROUND

MeSH Terms

Conditions

Pain, PostoperativeAgnosia

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsPerceptual DisordersNeurobehavioral ManifestationsNervous System Diseases

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This is a single-center, prospective, superiority, randomized, double-blind, parallel-group study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. Med. Eric Albrecht, Associate Professor, University of Lausanne

Study Record Dates

First Submitted

June 15, 2026

First Posted

June 24, 2026

Study Start

June 1, 2026

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

September 1, 2027

Last Updated

June 24, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations