Clinical trial NCT06883279: Effect of Interscalene Block Methods on Rebound Pain
Official 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Anesthesia
Pain, Shoulder
Pain, Postoperative
Keywords: Anesthesia
Interscalene block
Rebound pain
Lead sponsor: Ankara City Hospital Bilkent
Sponsor class: OTHER
First posted: 2025-03-19
Enrollment: 94
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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).

Primary outcomes:
measure: Rebound pain
timeFrame: 36 hours
Secondary outcomes:
measure: Number of needle passes
timeFrame: During the block procedure time
measure: Block performance time
timeFrame: During the block procedure time
measure: Rescue analgesic
timeFrame: 36 hours
measure: Duration of rebound pain
timeFrame: 36 hours
measure: Onset of sensory block
timeFrame: Preoperative time
measure: Onset of motor block
timeFrame: Preoperative time
measure: Duration of block effectiveness
timeFrame: 36 hours
measure: PONV
timeFrame: 36 hours
measure: Paresthesia
timeFrame: During the block procedure time
measure: Horner's syndrome
timeFrame: Perioperative/Periprocedural
measure: Dyspnea
timeFrame: Perioperative/Periprocedural
measure: Hoarseness
timeFrame: Perioperative/Periprocedural
measure: Intraoperative use of dexmedetomidine
timeFrame: Intraoperative time
measure: Pain scores
timeFrame: 36 hours
measure: Duration of stay in the recovery room
timeFrame: up to 2 hours post surgery
measure: Quality of recovery
timeFrame: Preoperative day 1, postoperative days 1 and 7.
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara Bilkent City Hospital
state: Ankara, Çankaya
Study officials:
References: