Effect of Interscalene Block Methods on Rebound Pain

Ankara City Hospital Bilkent85 enrolled

Overview

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).

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

Conditions

Anesthesia Pain, Shoulder Pain, Postoperative

Interventions

IntraplexusOTHER

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

ExtraplexusOTHER

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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).

Locations (1)

Ankara Bilkent City Hospital

Ankara, Ankara, Çankaya, Turkey (Türkiye)

Outcomes

Primary Outcomes

Rebound pain

Time frame: 36 hours

Secondary Outcomes

Number of needle passes

Number of times the needle is withdrawn and reinserted

Time frame: During the block procedure time

Block performance time

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

Time frame: During the block procedure time

Rescue analgesic

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.

Time frame: 36 hours

Duration of rebound pain

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.

Time frame: 36 hours

Onset of sensory block

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

Data from ClinicalTrials.gov

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