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NCT Number: NCT05141461

The Effect of Intravenous Dexamethasone on Rebound Pain After Interscalene Brachial Plexus Block for Shoulder Surgery

The rebound pain after nerve block could interfere with the patient's recovery and rehabilitation. It is not known how intravenous dexamethasone affects rebound pain. This study aims to evaluate the effect of intravenous dexamethasone on rebound pain after interscalene block for shoulder surgery.

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Key information

Conditions

Rebound Pain

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Karaman Training and Research Hospital

Karaman, 70200, Turkey (Türkiye)

About this study

Shoulder rotator cuff repair and acromioplasty are associated with severe postoperative pain. The interscalene block (ISB) is commonly used for this type of surgery, providing analgesia by anesthetizing the nerves that supply the shoulder. Although the nerve block provides extremely effective analgesia for the first 6-8 hours, patients experience severe pain once its effect has been wearing off. Rebound pain is a severe pain that occurs when the effect of a nerve block disappears in a patient during the postoperative period. The purpose of this study is to investigate whether the use of intravenous dexamethasone reduces rebound pain in patients recruiting for shoulder surgery with interscalene brachial plexus blockade.

This study will be conducted as a single-center, prospective, randomized, double-blinded trial in a university hospital. Patients scheduled for elective shoulder surgery will be screened for enrollment in the study. All subjects will undergo ultrasound-guided interscalene nerve block before induction of general anesthesia. They will be randomly assigned into the two groups which use intravenous dexamethasone or not. An anesthesiologist who will perform blocks will not involve in the data collection. Other health care workers who will involve in the evaluation of postoperative pain scores, nausea and vomiting, opioid consumption, quality of Sleep, and Quality of Recovery score will be blinded to the group assignment.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Undergoing shoulder surgery
  • Having signed a written informed consent form,
  • ASAI-III

Exclusion criteria

  • Inadequate indication for interscalene block (Coagulation disorder, local infection of block site, Diaphragmatic paralysis, Allergy to local anesthetics)
  • Neuropathic disorder
  • Severe cardiopulmonary disease
  • Systemic steroid use
  • Chronic opioids use
  • Stomach ulcer
  • Ucontrolled Diabetes
  • Psychiatric disorders,
  • Pregnancy,
  • Severe obesity (body mass index > 35 kg/m2)

Treatment and study plan

group C

Procedure

Patients will receive 2 mg midazolam and 50 ug fentanyl for sedation before the block procedure. Each patient will be positioned appropriately, then a high-frequency linear array transducer (13-6 MHz) will be placed in the interscalene region to define the brachial plexus on the short axis. Under sterile conditions, a 50 mm block needle will be advanced into the interscalen area using the in-plane method. After localization and negative aspiration, 15 ML of 5% bupivacaine drug will be injected into the interscalene area. 100 ml of NACI will be given intravenously within 15 minutes.

General anesthesia will be performed using 2 mg/kg of propofol and 1-2 µg/kg of fentanyl. Tracheal intubation will be facilitated with 0.6mg/kg rocuronium. Anesthesia will be maintained using 50% oxygen and 2% sevoflurane. Patients will be extubated into the operating room after reversing residual muscle relaxation. A multimodal analgesia regimen will be applied postoperatively.

Group Dex

Procedure

Patients will receive 2 mg midazolam and 50 ug fentanyl for sedation before the block procedure. Each patient will be positioned appropriately, then a high-frequency linear array transducer (13-6 MHz) will be placed in the interscalene region to define the brachial plexus on the short axis. Under sterile conditions, a 50 mm block needle will be advanced into the interscalene area using the in-plane method. After localization and negative aspiration, 15 ML of 5% bupivacaine drug will be injected into the interscalene area. 5 mg dexamethasone intravenously will be given in 100 ml NACI within 15 minutes.

General anesthesia will be performed using 2 mg/kg of propofol and 1-2 µg/kg of fentanyl. Tracheal intubation will be facilitated with 0.6mg/kg rocuronium. Anesthesia will be maintained using 50% oxygen and 2% sevoflurane. Patients will be extubated into the operating room after reversing residual muscle relaxation. A multimodal analgesia regimen will be applied postoperatively.

Primary outcomes

  1. The difference of pain score before and after interscalene block resolution

    Time frame: First 12 hours after interscalene block effect disappears

    The difference in the pain score between when the block is working and when it has resolved. Pain scores (0 = no pain; 10 = worst pain imaginable) using a Numerical Rating Scale (NRS) ranging from 0 to 10.

  2. Incidence of rebound pain

    Time frame: One week after surgery

    Rebound pain is described as severe pain (NRS ≥ 7)

Secondary outcomes

  1. Analgesic consumption

    Time frame: Postoperative 48 hours

    Rescue analgesic consumption in the first 48 hours postoperatively will be recorded.

  2. Quality of Recovery 15 Score

    Time frame: Postoperative day 1 and day 7

    Quality of Recovery (QoR)-15 survey.Minimum value: 0, Maximum value: 150, higher scores mean better.

  3. Numeric Rating Scale pain score ( NRS)

    Time frame: Postoperative 48 hours

    Pain scores (0 = no pain; 10 = worst pain imaginable) using a Numerical Rating Scale (NRS) ranging from 0 to 10. It will be recorded at the 2nd, 4th, 6th, 8th, 12th, 16th, 18th, and 24th hours in the postoperative period

  4. Interscalene block resolution time

    Time frame: Postoperative 24 hours

    The time of the first analgesic request. If the patient will not need analgesic, the block will be accepted as resolved when numbness or heaviness will not be felt by the patient.

  5. Glucose measurement

    Time frame: Postoperative 24th hour

    Glucose measurement

  6. Number of Participants with Surgical infection

    Time frame: Postoperative 14 days

    Number of Participants diagnosed with surgical infection

  7. Sleep Quality measured with Likert Scale

    Time frame: One week after surgery

    Patients' perceived sleep quality will be assessed with a Likert scale. Likert scale is scored from Likert scale where 1 = very dissatisfied, 2 = dissatisfied, 3 = neutral, 4 = satisfied and 5 = very satisfied.

Sponsors and collaborators

Lead sponsor

Karaman Training and Research Hospital

Other

Registry information

Official study title

The Effect of Intravenous Dexamethasone on Rebound Pain After Interscalene Brachial Plexus Block for Shoulder Surgery: a Randomized Controlled Trial

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Dec 2, 2021
Registry last updated
Jun 1, 2022

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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