Comparison of Erector Spinae Block and Combined Deep and Superficial Serratus Anterior Plane Block

• Sponsor: Uludag University (Other)
• Overall Status: Completed
• CT.gov ID: NCT06073197
• Collaborator: (none)
• Enrollment: 70
• Location: 1
• Arms: 2
• Actual Duration (Months): 7.8
• Patients Per Site Per Month: 9

Study Details

Study Description

Brief Summary

Objective: The authors hypothesized that combined deep and superficial serratus anterior plane block (SAPB) is as effective as erector spinae plane block (ESPB) for intraoperative and postoperative analgesia for video-assisted thoracoscopic surgery.

Design: A prospective randomized controlled study. Participants: Adult patients undergoing elective video-assisted thoracoscopic surgery.

Interventions: Preoperative SAPB or ESPB implementation.

Condition or Disease	Intervention/Treatment	Phase
Analgesia; Pain, Postoperative; Thoracic; Anesthesia	Procedure: erector spinae plane block; Procedure: combined deep and superficial serratus anterior plane block	N/A

Detailed Description

Plane blocks implemented on preoperative course on 35 patients for each group. Postoperative Visual Analogue Scale (VAS) scores (0-10), intraoperative and postoperative analgesic consumption was measured using Mann-Whitney test. In the postoperative phase, opioid side effects, complications related to plane blocks, mobilization time and length of hospital stay was recorded and measured.

Study Design

• Study Type: Interventional
• Actual Enrollment: 70 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: randomized, controlledrandomized, controlled
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Other
• Official Title: Comparision of the Effects of Ultrasound-guided Erector Spinae Block and Combined Deep and Superficial Serratus Anterior Plane Block on Perioperative Analgesia for Video-assisted Thoracoscopic Surgery.
• Actual Study Start Date: Jul 2, 2020
• Actual Primary Completion Date: Feb 25, 2021
• Actual Study Completion Date: Feb 25, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: erector spinae plane block Plane blocks implemented on preoperative course on 35 patients for group.	Procedure: erector spinae plane block; Erector spinae plane block was implemented on preoperative course on 35 patients. Intraoperative analgesic (Fentanyl) consumption was measured for intraoperative effects of the erector spinae plane block. Postoperative Visual Analogue Scale (VAS, from 0 to 10) scores and postoperative analgesic (Morphine) consumption was measured using Mann-Whitney test.
Active Comparator: combined deep and superficial serratus anterior plane block Plane blocks implemented on preoperative course on 35 patients for group.	Procedure: combined deep and superficial serratus anterior plane block; Combined deep and superficial serratus anterior plane block was implemented on preoperative course on 35 patients. Intraoperative analgesic (Fentanyl) consumption was measured for intraoperative effects of the erector spinae plane block Postoperative Visual Analogue Scale (VAS, from 0 to 10) scores and postoperative analgesic (Morphine) consumption was measured using Mann-Whitney test.

Outcome Measures

Primary Outcome Measures

1. postoperative analgesic effects [first 48 hours]

   The primary outcome is compare the postoperative analgesic effects of SAPB and ESPB applied under USG guidance before surgery in patients scheduled for VATS using VAS (Visual Analogue Scale from 0 to 10).

2. intraoperative analgesic effects [intraoperative phase]

   The primary outcome is compare the intraoperative analgesic effects of SAPB and ESPB applied under USG guidance before surgery in patients scheduled for VATS by measuring perioperative fentanyl consumption in both groups.

Secondary Outcome Measures

1. side effects [first 48 hours]

   The secondary aim was to compare the opioid side effects. Patients were informed about opioid side effects and asked whether side effects were present.

2. complications [first 48 hours]

   The secondary aim was to compare the complications related to the applied block. Patients were examined and evaluated for any complications related to the block.

3. mobilization [first 48 hours]

   The secondary aim was to compare the mobilization time

4. stay of hospital [first 4 days]

   length of stay in the recovery unit and hospital

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• American Society of Anaesthesiologists (ASA) classification I-II scheduled for elective VATS

Exclusion Criteria:

• Patients who did not give consent

• Local anaesthetic allergy

• Known or suspected coagulopathy

• İnfection at the injection site

• History of thoracic surgery

• Severe cardiovascular disease

• Hepatic or renal insufficiency (glomerular filtration rate <15 ml/min/1.73 m2)

• Severe neurological or psychiatric disorders

• Chronic opioid use

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Bursa Uludag University	Bursa		Turkey

Sponsors and Collaborators

• Uludag University

Investigators

• Study Chair: seda cansabuncu, Uludag University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Seda Cansabuncu, medical doctor, Uludag University
• ClinicalTrials.gov Identifier: NCT06073197
• Other Study ID Numbers: 2020-11/19
• First Posted: Oct 10, 2023
• Last Update Posted: Oct 10, 2023
• Last Verified: Oct 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Seda Cansabuncu, medical doctor, Uludag University: serratus anterior plane block; video-assisted thoracoscopic surgery; erector spinae block; postoperative analgesia
• Additional relevant MeSH terms: Pain, Postoperative

Study Results

No Results Posted as of Oct 10, 2023