Effect of Interscalene Block Methods on Rebound Pain

NCT ID: NCT06883279

Last Updated: 2025-11-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 85 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-20
• Study Completion Date: 2025-10-20

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.

Conditions

Anesthesia; Pain, Shoulder; Pain, Postoperative

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Intraplexus approach in interscalene block

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

Group Type: ACTIVE_COMPARATOR

Intraplexus

Intervention Type: 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 approach in interscalene block

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.

Group Type: ACTIVE_COMPARATOR

Extraplexus

Intervention Type: 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.

Interventions

Intraplexus

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

Intervention Type: OTHER

Extraplexus

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.

Intervention Type: OTHER

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ankara City Hospital Bilkent

OTHER

Sponsor Role: lead

Responsible Party

Gökhan Erdem

Anesthesiology and Reanimation specialist doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ankara Bilkent City Hospital

Ankara, Ankara, Çankaya, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

Rebound pain

Identifier Type: -

Identifier Source: org_study_id