The Efficacy of SPSIPB on Postoperative Pain and Analgesic Consumption in Patients Undergoing VATS

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Primary Purpose

Status

Completed

Phase

Not Applicable

Locations

Turkey

Study Type

Interventional

Intervention

Serratus posterior superior intercostal plane block (SPSIPB)

About this trial

This is an interventional other trial for Post Operative Pain focused on measuring serratus posterior superior intercostal plane block, video assisted thoracoscopic surgery, postoperative pain, regional anesthesia

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Adult patients older than 18 years of age who underwent video-assisted thoracoscopic surgery (VATS) under general anesthesia and were American Society of Anesthesiologists (ASA) I-II-III according to the ASA risk classification. Exclusion Criteria: Patients who did not give consent, patients with coagulopathy, patients with signs of infection at the block application site, patients using anticoagulants, patients with local anesthetic drug allergies, patients undergoing open surgery, patients with unstable hemodynamics, patients who could not cooperate during postoperative pain assessment

Sites / Locations

Sivas Cumhuriyet University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

SPSIPB

Control

Arm Description

Serratus posterior superior intercostal plane block is the intervention used in this study. It was performed when the patient is in lateral decubitis position. A high frequency (7-12 MHz) linear transducer of the ultrasound device is placed at the spinae scapula level in the transverse plane, and the upper medial border of the scapula, the trapezius muscle, rhomboid muscle, serratus posterior superior muscle (SPSM) and the second and third ribs are visualized. The sonovisible needle is then advanced immediately medial to the scapula, aiming for the area between the second and third ribs in order to reach the fascial plane between the SPSM and intercostal muscles. After contact of the needle with the rib gently, 1-2mL of saline is used to confirm the correct plane, and a total of 30 mL of 0.25% bupivacaine is administered to the superficial to the intercostal muscle. PCA device was also performed to this group with the same protocol which was detailed in control arm.

Control group patients were not subjected to any block or local infiltration anesthesia (local anesthetic administration around the incision). Their postoperative pain was relieved with tramadol (intravenous analgesic drug) administration by using patient-controlled analgesia (PCA) device. Patient-controlled analgesia was achieved with tramadol hydrochloride at a concentration of 4 mg per 1 ml with the PCA device. The PCA device was configured to administer the patients boluses of 10 mg tramadol hydrochloride with a lockout time of 20 minutes, allowing a maximum of 4 pushes per hour. The total dose was standardized for all patients with a maximum daily dose of 400 mg and a maximum dose of 100 mg tramadol hydrochloride every 6 hours.

Outcomes

Primary Outcome Measures

Numerical rating scale (NRS) scores

Numerical rating scale is used for pain assessment. The scores of the numerical rating scale changes between 0 to 10 points. 10 points mean "the most severe pain that the patient ever had". 0 point means "there is no pain." Higher scores mean worse outcome.

Secondary Outcome Measures

Total tramadol consumption

Postoperative analgesic (tramadol) need is measured by using patient-controlled analgesia (PCA) device.

Full Information

NCT ID

NCT05901103

First Posted

June 1, 2023

Last Updated

June 12, 2023

Sponsor

Cumhuriyet University

1. Study Identification

Unique Protocol Identification Number

NCT05901103

Brief Title

The Efficacy of SPSIPB on Postoperative Pain and Analgesic Consumption in Patients Undergoing VATS

Official Title

The Efficacy of Serratus Posterior Superior Intercostal Plane Block (SPSIPB) on Postoperative Pain and Total Analgesic Consumption in Patients Undergoing Video-assisted Thoracoscopic Surgery (VATS)

Study Type

Interventional

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Completed

Study Start Date

March 29, 2023 (Actual)

Primary Completion Date

May 25, 2023 (Actual)

Study Completion Date

June 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Cumhuriyet University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The aim of this study is to investigate the postoperative analgesic efficacy of SPSIPB and its effect on opioid consumption in patients undergoing video-assisted thoracoscopic surgery (VATS).

Detailed Description

There were two randomized groups: Group S (SPSIPB) (n=12), Group C (no block) (n=12). All patients had standard general anesthesia. Group S had serratus posterior superior intercostal plane block (SPSIPB) with 0.25% bupivacaine (total volume of 30 ml) at the end of the surgery. Group Control had only tramadol for postoperative pain. Numerical rating scale (NRS) was used to assess postoperative pain on 1st, 6th, 12th and 24th hour after the surgery. Total tramadol consumption was calculated using patient-controlled analgesia (PCA) device.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Post Operative Pain

Keywords

serratus posterior superior intercostal plane block, video assisted thoracoscopic surgery, postoperative pain, regional anesthesia

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

24 (Actual)

8. Arms, Groups, and Interventions

Arm Title

SPSIPB

Arm Type

Active Comparator

Arm Description

Serratus posterior superior intercostal plane block is the intervention used in this study. It was performed when the patient is in lateral decubitis position. A high frequency (7-12 MHz) linear transducer of the ultrasound device is placed at the spinae scapula level in the transverse plane, and the upper medial border of the scapula, the trapezius muscle, rhomboid muscle, serratus posterior superior muscle (SPSM) and the second and third ribs are visualized. The sonovisible needle is then advanced immediately medial to the scapula, aiming for the area between the second and third ribs in order to reach the fascial plane between the SPSM and intercostal muscles. After contact of the needle with the rib gently, 1-2mL of saline is used to confirm the correct plane, and a total of 30 mL of 0.25% bupivacaine is administered to the superficial to the intercostal muscle. PCA device was also performed to this group with the same protocol which was detailed in control arm.

Arm Title

Control

Arm Type

No Intervention

Arm Description

Control group patients were not subjected to any block or local infiltration anesthesia (local anesthetic administration around the incision). Their postoperative pain was relieved with tramadol (intravenous analgesic drug) administration by using patient-controlled analgesia (PCA) device. Patient-controlled analgesia was achieved with tramadol hydrochloride at a concentration of 4 mg per 1 ml with the PCA device. The PCA device was configured to administer the patients boluses of 10 mg tramadol hydrochloride with a lockout time of 20 minutes, allowing a maximum of 4 pushes per hour. The total dose was standardized for all patients with a maximum daily dose of 400 mg and a maximum dose of 100 mg tramadol hydrochloride every 6 hours.

Intervention Type

Other

Intervention Name(s)

Serratus posterior superior intercostal plane block (SPSIPB)

Intervention Description

Serratus posterior superior intercostal plane block is the intervention used in this study. It was performed when the patient is in lateral decubitis position. A high frequency (7-12 MHz) linear transducer of the ultrasound device is placed at the spinae scapula level in the transverse plane, and the upper medial border of the scapula, the trapezius muscle, rhomboid muscle, serratus posterior superior muscle (SPSM) and the second and third ribs are visualized. The sonovisible needle is then advanced immediately medial to the scapula, aiming for the area between the second and third ribs in order to reach the fascial plane between the SPSM and intercostal muscles. After contact of the needle with the rib gently, 1-2mL of saline is used to confirm the correct plane, and a total of 30 mL of 0.25% bupivacaine is administered to the superficial to the intercostal muscle.

Primary Outcome Measure Information:

Title

Numerical rating scale (NRS) scores

Description

Numerical rating scale is used for pain assessment. The scores of the numerical rating scale changes between 0 to 10 points. 10 points mean "the most severe pain that the patient ever had". 0 point means "there is no pain." Higher scores mean worse outcome.

Time Frame

Postoperative 24 hours

Secondary Outcome Measure Information:

Title

Total tramadol consumption

Description

Postoperative analgesic (tramadol) need is measured by using patient-controlled analgesia (PCA) device.

Time Frame

Postoperative 24 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria: Adult patients older than 18 years of age who underwent video-assisted thoracoscopic surgery (VATS) under general anesthesia and were American Society of Anesthesiologists (ASA) I-II-III according to the ASA risk classification. Exclusion Criteria: Patients who did not give consent, patients with coagulopathy, patients with signs of infection at the block application site, patients using anticoagulants, patients with local anesthetic drug allergies, patients undergoing open surgery, patients with unstable hemodynamics, patients who could not cooperate during postoperative pain assessment

Facility Information:

Facility Name

Sivas Cumhuriyet University

City

Sivas

ZIP/Postal Code

58000

Country

Turkey

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

36883093

Citation

Tulgar S, Ciftci B, Ahiskalioglu A, Bilal B, Sakul BU, Korkmaz AO, Bozkurt NN, De Cassai A, Torres AJ, Elsharkawy H, Alici HA. Serratus Posterior Superior Intercostal Plane Block: A Technical Report on the Description of a Novel Periparavertebral Block for Thoracic Pain. Cureus. 2023 Feb 3;15(2):e34582. doi: 10.7759/cureus.34582. eCollection 2023 Feb.

Results Reference

background

Post Operative Pain

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial