Evaluating the Analgesic Efficacy of Combined Individual Nerve Block in Comparison to Interscalene Nerve Block

Evaluating the Analgesic Efficacy of Combined Individual Nerve Block in Comparison to Interscalene Nerve Block in Patients Undergoing Shoulder Arthroscopic Assisted Adhesiolysis

Patients undergoing total shoulder arthroscopic adhesiolysis may experience severe postoperative pain. Inadequate pain management can result in unfavourable hospital outcomes and the development of persistent neuropathic manifestation the aim of the study is to compare both ultrasound techniques (combined individual nerve block to interscalene nerve block) as regards the postoperative analgesic effect and shoulder range of movement.

Study Overview

• Status: Completed
• Conditions: Postoperative Pain
• Intervention / Treatment: Procedure: interscalene block; Drug: bupivacaine; Procedure: selective nerve block

Detailed Description

60 patients will be attached to standard monitoring, will have a secured intravenous line Then the skin overlying the procedure area will be sterilized. all patients will be randomly divided into two equal groups; group A will receive ultrasound-guided interscalene block (ISNB), and group B will receive ultrasound-guided selective nerve block (SNB) of the following nerves; suprascapular nerve block (SSNB), axillary nerve block (ANB), lateral pectoral nerve block (LPNB) and musculocutaneous nerve block (MCNB).

after delivering the nerve block and confirming sensory blockade by loss of cold sensation, all the patients will receive general anaesthesia with endotracheal intubation using Propofol 200mg, Atracurium 0.5 mg/kg, 100 micrograms fentanyl.

After the procedure ends, the patient will be extubated and transferred to the postoperative anaesthesia care unit. All patients will receive patient-controlled analgesia (PCA) in the form ketorolac 30 mg and paracetamol one-gram iv infusion.

The following parameter will be assessed and measured;

1. Intra-operative inhalation agent consumption
2. Intraoperative opioid consumption (fentanyl) if required.
3. Duration of postoperative analgesia and time for first rescue analgesia will be recorded. Rescue analgesia in the form of 100mg pethidine IM and 1 gm paracetamol IV will be given on the first call for analgesia and then repeated on demand. The total dose of pethidine and paracetamol are given throughout the first 24 hours will be recorded.
4. The time for asking for rescue analgesia in the first 24 h and the dose of the analgesic used will also be recorded.
5. The degree of postoperative pain assessed by Visual Analogue Scale (VAS)
6. Duration of the block: time from completing LA injection till complete recovery of sensory function, i.e., the patient feels a cold sensation
7. Postoperative range of motion of the operated shoulder
8. Patients" satisfaction (yes or no or somewhat satisfied)
9. Block-related complications will be also recorded e.g. paraesthesia, and postoperative motor weakness 24 hours after the surgery, pneumothorax and vascular puncture.

• Study Type: Interventional
• Enrollment (Actual): 128
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 69711
    • Ain Shams University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 58 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• ASA I, II
• scheduled for arthroscopic assisted adhesiolysis

Exclusion Criteria:

• restrictive lung disease,
• refusal of the procedure,
• coagulopathy,
• allergy to any of the used medications

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: group A: receive ultrasound-guided interscalene block; The patient will be put in the supine position, with the arm adducted a high-frequency linear ultrasound probe is oriented transversely across the lateral neck. When visualizing the ''stoplight sign,''15 to 30 mL of 0.25% bupivacaine consistent with the overall local anaesthetic dosing of less than 2.5 mg/kg. will be injected with low pressures to avoid intraneural injection.	Procedure: interscalene block; The patient will be put in the supine position, with the arm adducted a high-frequency linear ultrasound probe is oriented transversely across the lateral neck. When visualizing the ''stoplight sign,''15 to 30 mL of 0.25% bupivacaine will be injected; Drug: bupivacaine; bupivacaine
Active Comparator: group B: receive ultrasound-guided selective nerve block; The patient will be put in the sitting position, a linear 38-mm high frequency 10-12 MHz transducer will be placed first on the scapula to obtain a view of the suprascapular nerve a 22 G, 8 cm needle will be advanced in-plane and a total of 5-8 mL of 0.25% bupivacaine is injected then the arm adducted the linear probe will be placed at the junction of the pectoralis major muscle and the biceps muscle such that the axillary artery will be visualized in cross-section The probe will be moved towards the biceps muscle (laterally) until the musculocutaneous nerve is visualized and8 ml of 0.25% bupivacaine will be injected	Drug: bupivacaine; bupivacaine; Procedure: selective nerve block; the patient will be put in the sitting position, linear 38-mm high frequency 10-12 MHz transducer will be placed first on the scapula to view of the suprascapular nerve. 5-8 mL of 0.25% bupivacaine is injected to block the SSN. The ultrasound probe put on the posterior aspect of the shoulder to view the circumflex artery, 10 mL of 0.25% bupivacaine this will lead to loss of sensation over the deltoid.lateral pectoral nerve block (LPNB) will be done by injecting a volume of 8 ml of a 0.25% bupivacaine The probe will be moved towards the biceps muscle until the musculocutaneous nerve is seen and 8 ml of 0.25% bupivacaine will be injected.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the duration of postoperative analgesia	postoperative pain by visual analogue scale (VAS) a 10 point scale where 1 means no pain and 10 means worst pain ever	24 hours postoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
range of motion of the operated shoulder	free or limited	24 hours postoperative

Collaborators and Investigators

• Sponsor: Ain Shams University
• Investigators: Study Chair: Fathy M Tash, MD, Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Actual): October 30, 2021
• Study Completion (Actual): October 30, 2021

Study Registration Dates

• First Submitted: January 7, 2021
• First Submitted That Met QC Criteria: January 13, 2021
• First Posted (Actual): January 14, 2021

Study Record Updates

• Last Update Posted (Actual): February 14, 2022
• Last Update Submitted That Met QC Criteria: February 11, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine
• Other Study ID Numbers: FMASU R 131/2020

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No