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

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04709250
• Other study ID #: FMASU R 131/2020
• Status: Completed
• Phase: N/A
• Start date: January 1, 2021
• Est. completion date: October 30, 2021

Study information

• Verified date: February 2022
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 128
• Est. completion date: October 30, 2021
• Est. primary completion date: October 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

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
• 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.

Drug:
• bupivacaine
bupivacaine

Locations

Country	Name	City	State
Egypt	Ain Shams University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	range of motion of the operated shoulder	free or limited	24 hours postoperative