A Comparative Study Between Ultrasound Guided Thoracic Paravertebral Block VS Serrartus Anterior Muscle Block in VATS as Regard Their Effectiveness in Post-operative Analgesia

Not Applicable

Recruiting

• Conditions: Post Operative Pain, Acute
• Interventions: Procedure: thoracic paravertebal block; Procedure: serratus anterior muscle block

• Registration Number: NCT05971368
• Lead Sponsor: Ain Shams University

Brief Summary

A comparative study between ultrasound guided thoracic paravertebral block VS ultrasound guided serrartus anterior muscle block in video-assisted thoracoscopic surgeries as regard their effectiveness in post-operative analgesia

Detailed Description

The use of loco-regional analgesia is recommended to control postoperative pain after VATS as it allows opioid sparing and facilitates early postoperative rehabilitation. Different loco-regional analgesic techniques could be used to control pain after thoracic surgery such as a paravertebral block, an intercostal block and serratus plane block. In this study, Thoracic paravertebral nerve block will be compared to Serratus anterior nerve block, both will be done Ultrasound guided (USG) using bupivacaine (0.25%) for postoperative analgesia.

Study Timeline

• Study Start: 2022-06-04
• Status Verified: 2023-06
• Study First Submitted: 2023-06-16
• Study First Submitted QC: 2023-07-31
• Study First Posted: 2023-08-02
• Primary Completion: 2024-01-04
• Last Update Submitted: 2024-02-07
• Last Update Posted: 2024-02-08
• Study Completion: 2024-02-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Patients American Society of Anesthesiologists physical status (ASA) I to II
• Both sexes.
• Aged ≥ 20 to ≤ 65years.
• Scheduled for VATS under general anesthesia.

Exclusion Criteria

• Patient's refusal.
• Patients American Society of Anesthesiologists physical status (ASA) III to IV
• Patients with major spine deformities.
• Disruption of the local anatomy, secondary, for instance, to the presence of chest drains or surgical emphysema, resulting in difficulty in ultrasound interpretation and distortion of tissue planes.
• Patients with bleeding disorders and coagulopathy.
• Infection at the injection site.
• Known allergy to local anesthetics.
• Patients with pre-existing myopathy or neuropathy.
• Ipsilateral diaphragmatic paresis.
• Tumors in the paravertebral space at the level of injection.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A: Patients will receive ultrasound guided thoracic paravertebral block	thoracic paravertebal block	Group A: Patients will receive ultrasound guided thoraxic paravertebral block with 0.25% bupivacaine 0.4 ml/kg (max. 40 ml and not exceeding toxic dose of bupivacaine 2.5mg/kg) after induction of anesthesia.
Group B: Patients will receive ultrasound guided serratus anterior muscle block	serratus anterior muscle block	Group B: Patients will receive ultrasound guided serratus anterior muscle block with 0.25% bupivacaine 0.4 ml/kg (max. 40 ml and not exceeding toxic dose of bupivacaine 2.5mg/kg) after induction of anesthesia.

Primary Outcome Measures

Name	Time	Method
visual analog scale (VAS)	the first 24 hours postoperatively	Postoperative pain will be assessed at time of evaluation or at any time the patient is complaining of pain by using visual analog scale (VAS) and VAS more than 4 will be managed by injection of nalbuphine 5mg intravenously as a first rescue analgesia to reduce VAS score ≤ 3
total amount of opioid consumption in the two groups according to change in VAS score	the first 24 hours postoperatively	Postoperative pain will be assessed at time of evaluation or at any time the patient is complaining of pain by using visual analog scale (VAS) and VAS more than 3 will be managed by injection of nalbuphine 0.05mg / kg intravenously as a first rescue analgesia to reduce VAS score ≤ 3 and another titrating dose (2-3 mg nalbuphine) will be considered if the patient is still complaining in order to reach VAS score ≤ 3 (with maximum dose of 10 mg nalbuphine at a time)

Secondary Outcome Measures

Name	Time	Method
onset of ambulation	first 24 hours postoperatively	controlling pain postoperatively will help in early ambulation which is a major goal post operative to decrease complications
The onset of 1st analgesic request	The first 24 hours postoperatively	Postoperative pain will be assessed by using visual analog scale (VAS) and VAS more than 4 will be managed by injection of nalbuphine 5mg intravenously as a first rescue analgesia to reduce VAS score ≤ 3. comparison will be done between the two groups in the onset of 1st analgesic request
mean arterial blood pressure of the patients	first 24 hours postoperatively	After surgery, Patients will be observed immediately post-operative at 0 (PACU), and 2, 4, 8, 12, 24 hours after surgery for post-operative pain in form of increasing mean arterial blood pressure as a sign of uncontrolled pain
complication of nerve block	first 24 hours postoperatively	as hematoma , infection , pneumothorax .
heart rate of the patients	first 24 hours postoperatively	After surgery, Patients will be observed immediately post-operative at 0 (PACU), and 2, 4, 8, 12, 24 hours after surgery for post-operative pain in form of increasing heart rate above 90 (pulse per min )as a sign of uncontrolled pain

Trial Locations

Locations (1)

Faculty of medicine Ain shams university; 🇪🇬 Cairo, Abbasia, Egypt