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Completed

NCT Number: NCT06883279

Effect of Interscalene Block Methods on Rebound Pain

In this study, the hypothesis that local anesthesia, not directly injected into the nerve root, may reduce the incidence of rebound pain in the interscalene block with an extraplexus approach during arthroscopic shoulder surgeries will be investigated. Rebound pain is defined as a short-term but severe pain before and after the resolution of the interscalene block and will be evaluated using the Numerical Rating Scale (NRS) (NRS ≥ 7).

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Key information

Conditions

Anesthesia Arthralgia Joint Diseases Musculoskeletal Diseases Neurologic Manifestations Pain Pain, Postoperative Pain, Shoulder Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Shoulder Pain Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ankara Bilkent City Hospital

Ankara, Ankara, Çankaya, 06800, Turkey (Türkiye)

About this study

The study will include patients aged 18-65 years, with an American Society of Anesthesiologists (ASA) physical status of I or II, scheduled for arthroscopic shoulder surgery in the lateral decubitus position, accompanied by interscalene nerve block performed by the same surgeon. Patient characteristics (age, gender, body mass index, etc.), block procedure duration, number of needle passes, onset time of sensory block, onset time of motor block, and possible complications related to the block (paresthesia, Horner's syndrome, dyspnea, hoarseness), postoperative nausea and vomiting (PONV) status, and Quality of Recovery-15 (QoR-15) scores on the preoperative first day and postoperative days 1 and 7 will be recorded. The primary outcome parameter will be the incidence of rebound pain. Rebound pain will be defined as a short-term but severe pain before and after the resolution of the interscalene block, assessed using the Numerical Rating Scale (NRS) (NRS ≥ 7). Secondary outcomes will include the number of needle passes, block application time, onset time of sensory block, onset time of motor block, intraoperative dexmedetomidine requirement, duration of block effectiveness, postoperative pain, PONV, need for rescue analgesics, incidence of paresthesia and Horner's syndrome, dyspnea, hoarseness, duration of stay in the recovery room, duration of rebound pain, and postoperative Quality of Recovery-15 (QoR-15) scores.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients aged 18-65 years.
  • Patients with ASA physical status I or II.
  • Patients planned for arthroscopic shoulder surgery in the lateral decubitus position with interscalene nerve block.

Exclusion criteria

  • Patients who do not consent to participate in the study.
  • Block failure.
  • Language acquisition deficiency.
  • Obesity (body mass index > 35 kg/m²).
  • Diabetes.
  • Psychiatric disorders.
  • Central nervous system diseases.
  • Vestibular diseases.
  • Presence of neuropathy and paralysis.
  • Pregnancy.
  • Previous open shoulder surgery.
  • Allergy to local anesthetics.
  • Coagulopathy.
  • Severe thrombocytopenia.
  • Infection at the puncture site.
  • Pre-existing neuropathy in the limb to be operated.
  • Use of dexamethasone.
  • Use of opioid and antiemetic medications before surgery.
  • Severe cardiopulmonary disease.
  • Low baseline oxygen saturation.
  • Conditions that prevent cooperation in the postoperative period (e.g., mental retardation, delirium).

Treatment and study plan

Intraplexus

Other

The block needle will be advanced from the middle scalene muscle in a posterior-anterior direction and advanced between the C5-C6 nerve roots and the injection will be performed

Extraplexus

Other

The block needle will first be advanced above the C5 nerve root and towards the anterior part of the brachial plexus and 10 ml of local anesthetic will be injected. Then, the needle will be withdrawn to the posterior surface of the brachial plexus and 10 ml of local anesthetic will be administered.

Primary outcomes

  1. Rebound pain

    Time frame: 36 hours

    Pain will be evaluated using the 0-10 Numerical Rating Scale (NRS), where 0 represents no pain and 10 represents the worst possible pain. Rebound pain will be defined as a short-term but severe pain occurring before and after the resolution of the interscalene block (NRS ≥ 7).

Secondary outcomes

  1. Number of needle passes

    Time frame: During the block procedure time

    Number of times the needle is withdrawn and reinserted

  2. Block performance time

    Time frame: During the block procedure time

    Time from the placement of the block needle to the completion of local anesthetic injection (minutes)

  3. Rescue analgesic

    Time frame: 36 hours

    Pain will be evaluated using the 0-10 Numerical Rating Scale (NRS), where 0 represents no pain and 10 represents the worst possible pain. During the postoperative period, if NRS ≥ 4 occurs, 100 mg of tramadol will be administered intravenously. This situation will be defined as the need for rescue analgesia.

  4. Duration of rebound pain

    Time frame: 36 hours

    Pain will be evaluated using the 0-10 Numerical Rating Scale (NRS), where 0 represents no pain and 10 represents the worst possible pain. Rebound pain will be defined as a short-term but severe pain occurring before and after the resolution of the interscalene block (NRS ≥ 7). The duration of rebound pain experienced by patients will be recorded in minutes based on the time the pain started and ended, as assessed in a questionnaire directed at the patients.

  5. Onset of sensory block

    Time frame: Preoperative time

    Duration (minutes) during which there is touch sensation but no pain in the relevant dermatomal areas in the Pin-Prick test.

  6. Onset of motor block

    Time frame: Preoperative time

    Duration (minutes) during which motor strength is reduced, but the arm is still movable.

  7. Duration of block effectiveness

    Time frame: 36 hours

    Time (minutes) until the patient reports a significant increase in pain after the block.

  8. PONV

    Time frame: 36 hours

    Significant nausea, vomiting, and/or need for rescue antiemetics.

  9. Paresthesia

    Time frame: During the block procedure time

    Observations during the block procedure of 'needle prick, tingling, or electric shock radiating to the arm

  10. Horner's syndrome

    Time frame: Perioperative/Periprocedural

    Miosis and ptosis of the ipsilateral pupil during the perioperative period.

  11. Dyspnea

    Time frame: Perioperative/Periprocedural

    Breathing difficulty as described by the patient during the perioperative period.

  12. Hoarseness

    Time frame: Perioperative/Periprocedural

    Voice changes described by the patient during the perioperative period.

  13. Intraoperative use of dexmedetomidine

    Time frame: Intraoperative time

    Ramsey Sedation Scale is a tool used to assess the sedation levels of patients, and it scores from 1 to 6. A score of 1 indicates that the patient is awake, agitated, and very active; a score of 2 indicates that the patient is awake but slightly agitated. A score of 3 indicates that the patient is awake but calm, while a score of 4 indicates that the patient responds but has decreased alertness. A score of 5 indicates that the patient is not awake but responds to stimulation; a score of 6 indicates that the patient is not awake and does not respond to stimuli. In the study, the necessary amount of dexmedetomidine (μg) will be recorded for patients to fall within the 3-4 range on the Ramsey Sedation Scale.

  14. Pain scores

    Time frame: 36 hours

    Evaluated using a 0-10 Numerical Rating Scale (NRS), where zero represents no pain and ten represents the worst pain imaginable.

  15. Duration of stay in the recovery room

    Time frame: up to 2 hours post surgery

    Time from arrival in the recovery room to the point when discharge criteria are met

  16. Quality of recovery

    Time frame: Preoperative day 1, postoperative days 1 and 7.

    The Quality of Recovery-15 (QoR-15) questionnaire consists of 15 questions rated on a scale of 0-10, with a total score evaluated out of 150. Results are classified as 'excellent' for scores above 135, 'good' for scores between 122-135, 'moderate' for scores between 90-121, and 'poor' for scores below 90.

Sponsors and collaborators

Lead sponsor

Ankara City Hospital Bilkent

Other

Registry information

Official study title

Effect of Intraplexus and Extraplexus Interscalene Block Approaches on the Incidence of Rebound Pain in Arthroscopic Shoulder Surgery: A Prospective, Randomized, Double-Blind Clinical Study

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Mar 19, 2025
Registry last updated
Nov 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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