Effect of Interscalene Block Methods on Rebound Pain

Not Applicable

Recruiting

• Conditions: Anesthesia; Pain, Shoulder; Pain, Postoperative

• Registration Number: NCT06883279
• Lead Sponsor: Ankara City Hospital Bilkent

Brief Summary

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).

Detailed Description

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.

Study Timeline

• Status Verified: 2025-03
• Study First Submitted: 2025-03-09
• Study First Submitted QC: 2025-03-12
• Study First Posted: 2025-03-19
• Study Start: 2025-03-20
• Last Update Submitted: 2025-03-21
• Last Update Posted: 2025-03-25
• Primary Completion: 2025-06-20
• Study Completion: 2025-07-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 94

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Rebound pain	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 Outcome Measures

Name	Time	Method
Number of needle passes	During the block procedure time	Number of times the needle is withdrawn and reinserted
Block performance time	During the block procedure time	Time from the placement of the block needle to the completion of local anesthetic injection (minutes)
Rescue analgesic	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.
Duration of rebound pain	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.
Onset of sensory block	Preoperative time	Duration (minutes) during which there is touch sensation but no pain in the relevant dermatomal areas in the Pin-Prick test.
Onset of motor block	Preoperative time	Duration (minutes) during which motor strength is reduced, but the arm is still movable.
Duration of block effectiveness	36 hours	Time (minutes) until the patient reports a significant increase in pain after the block.
PONV	36 hours	Significant nausea, vomiting, and/or need for rescue antiemetics.
Paresthesia	During the block procedure time	Observations during the block procedure of 'needle prick, tingling, or electric shock radiating to the arm
Horner's syndrome	Perioperative/Periprocedural	Miosis and ptosis of the ipsilateral pupil during the perioperative period.
Dyspnea	Perioperative/Periprocedural	Breathing difficulty as described by the patient during the perioperative period.
Hoarseness	Perioperative/Periprocedural	Voice changes described by the patient during the perioperative period.
Intraoperative use of dexmedetomidine	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.
Pain scores	36 hours	Evaluated using a 0-10 Numerical Rating Scale (NRS), where zero represents no pain and ten represents the worst pain imaginable.
Duration of stay in the recovery room	up to 2 hours post surgery	Time from arrival in the recovery room to the point when discharge criteria are met
Quality of recovery	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.

Trial Locations

Locations (1)

Ankara Bilkent City Hospital; 🇹🇷 Ankara, Ankara, Çankaya, Turkey