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Clinical Trials/NCT05755802
NCT05755802CompletedNot Applicable

Ultrasound-guided Shoulder Block Versus Pericapsular Nerve Group Block (PENG) for Postoperative Analgesia in Arthroscopic Shoulder Surgery: a Randomized Controlled Trial

Mansoura University1 site in 1 country46 target enrollmentStarted: June 5, 2023Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
46
Locations
1
Primary Endpoint
First analgesic request

Study Overview

Brief Summary

Effective analgesia in arthroscopic shoulder surgery is a major concern and is essential for all aspects of the patient's recovery. The aim of this study is to assess the quality of pain relief in patients who will undergo arthroscopic shoulder surgeries receiving either shoulder block versus PENG block comparing and evaluating the differences between the two techniques.It is hypothesized that PENG block will be comparable to shoulder block as a promising effective alternative for analgesia for arthroscopic shoulder surgeries with fewer side effects. It is suggested that the PENG block can be safely applied for analgesia.

Detailed Description

Effective analgesia in arthroscopic shoulder surgery is a major concern and is essential for all aspects of the patient's recovery. Multimodal pain management is recommended for early postoperative pain control. Regional anesthesia is preferred in shoulder surgery as an effective means of providing anesthesia and postoperative analgesia. Commonly used techniques for shoulder surgery include interscalene brachial plexus (ISB) blocks, continuous ISB (CISB) blocks, suprascapular nerve blocks (SSB), supraclavicular nerve blocks (SCB), local infiltration (LI), and ISB with adjuvants.Interscalene brachial plexus (ISB) block is considered the analgesic technique of choice for shoulder surgery. Shoulder block which is combination of suprascapular nerve block and axillary nerve block has been recently proposed as an alternative anesthetic and postoperative analgesic modality in this patient population. These two nerve blocks cause the loss of the sensory innervation of the shoulder. Shoulder block is advantageous to the interscalene brachial plexus block since it does not lead to respiratory dysfunction due to phrenic nerve palsy or other serious complications.The pericapsular nerve group (PENG) block may be safely applied for both partial anesthesia and analgesia in selected shoulder surgery cases. It did not cause motor block or pulmonary complications, nor result in muscle laxity, blocking only the shoulder and the upper third of the humerus. PENG block has been studied extensively in hip surgeries but its place in shoulder surgeries is not yet clear. Therefore, this study will be conducted to compare efficacy of ultrasound guided shoulder block with PENG block for postoperative analgesia in patients undergoing arthroscopic shoulder surgeries.

The aim of this study:

assess the quality of pain relief in patients who will undergo arthroscopic shoulder surgeries receiving either shoulder block versus PENG block comparing and evaluating the differences between the two techniques.

Sample Size Calculation:

Sample size was calculated using Power Analysis and Sample Size software program (PASS) version 11.0.4 for windows (2011) with time to first analgesic request as the primary outcome. Using the results published by Pani et al 2019 with the mean time to first analgesic request in shoulder block group was (5.9 ± 1.2 hours) Using a two-sided two-sample unequal-variance t-test, sample size of 40 patients is needed to achieve 90% power to detect 20 % difference in time to first analgesic request. Using a two-sided hypothesis test with a significance level of 0.05. A 10% drop out is considered, so a total of 46 patients will be enrolled (23 in each group) in this study.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Outcomes Assessor)

Masking Description

The study subjects and the resident assessing the outcomes will be blinded to the study group. A single investigator will assess the patients for eligibility, obtain written informed consent, open the sealed opaque envelopes containing group allocation, perform the block, and administer bupivacaine solution

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •American Society of Anesthesiology (ASA) 1 or 2 patients.
  • •Scheduled for elective unilateral shoulder arthroscopy.

Exclusion Criteria

  • •Patient's refusal.
  • •Altered mental status or un-cooperative patients.
  • •History of known sensitivity to the used anesthetics.
  • •Bleeding or coagulation diathesis.
  • •Infection or redness at the injection site.
  • •Significant cardiac dysfunction, hepatic, or renal impairment.

Arms & Interventions

Group A (PENG block)

Active Comparator

Ultrasound-guided PENG block will be performed under strict aseptic precautions and patient's arm will be placed in external rotation and abducted at 45 degrees.

Intervention: PENG block (Procedure)

Group B (Shoulder block)

Active Comparator

Ultrasound-guided shoulder block will be performed under strict aseptic precautions with patient in semi-recumbent position with the operating arm on the contra-lateral shoulder.and then, the patients will be positioned in a semi-recumbent position with the arm slightly flexed and adducted at the elbow for axillary nerve block.

Intervention: Shoulder block (Procedure)

Outcomes

Primary Outcomes

First analgesic request

Time Frame: Up to 24 hours after the procedure

The time of the first analgesic request for fentanyl will be recorded.

Secondary Outcomes

  • Visual analogue score (VAS) for pain assessment(Up to 24 hours after the procedure)
  • Mean arterial blood pressure (MAP)(During the procedure)
  • Heart rate (HR)(During the procedure)
  • Total analgesic requirements of fentanyl(Up to 24 hours after the procedure)
  • Adverse effects(Up to 24 hours after the procedure)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Amany Hazem abdelmaksood EL-deeb

Lecturer of anesthesia, ICU & pain management; Faculty of Medicine

Mansoura University

Study Sites (1)

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