Serratus Posterior Superior Interfascial Plane Block for Thoracoscopic Surgery

Sponsor

Medipol University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05972122

Collaborator

(none)

Enrollment

Location

Arms

3.8

Anticipated Duration (Months)

15.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Regional techniques can be used for postoperative pain control following VATS. Ultrasound (US) guided serratus posterior superior block (SPSPB) is a new interfacial plane block defined by Tulgar et al in 2023. It is based on injection on the serratus posterior superior muscle at the level of the 2nd or 3rd rib. This block provides analgesia in conditions such as interscapular pain, chronic myofascial pain syndromes, scapulocostal syndrome, and shoulder pain. The SPS muscle is located at the C7-T2 level. It attaches to the lateral edges of the second and fifth ribs. It is innervated by the lower cervical and upper intercostal nerves. With the SPS block, these nerves are blocked and analgesia is provided.

Condition or Disease	Intervention/Treatment	Phase
Lung Diseases	Drug: Analgesia management; group S and C	N/A

Detailed Description

Video-assisted thoracic surgery (VATS) has started to be considered the standard surgical procedure for lung surgery in recent years. The advantages of VATS compared to open thoracotomy are rapid recovery, shorter hospital stays, and low risk of complications. Although it is a less painful surgical procedure compared to thoracotomy, severe acute postoperative pain can be observed especially in the first hours after VATS. Thoracic epidural analgesia (TEA), which is the gold standard for post-thoracotomy analgesia, is used in analgesia after VATS. However, due to the difference in surgical technique and trauma between open surgery and VATS, what should be the gold standard for analgesia after VATS is a matter of debate. It is supported that less invasive analgesic techniques should be applied for minimally invasive surgical procedures, especially due to the difficulty of applying TEA and its side-effect profile. Thoracic paravertebral block (TPVB) is considered the first-line regional technique for VATS surgery. However, it is difficult to apply due to its anatomical proximity to important structures such as the pleura and central neuraxial system, and it may cause complications such as pneumothorax and vascular injury. Analgesia management is very important in these patients, as insufficient analgesia in the postoperative period may cause pulmonary complications such as atelectasis, pneumonia, and increased oxygen consumption.

Ultrasound (US) guided serratus posterior superior block (SPSPB) is a new interfacial plane block defined by Tulgar et al in 2023. It is based on injection on the serratus posterior superior muscle at the level of the 2nd or 3rd rib. This block provides analgesia in conditions such as interscapular pain, chronic myofascial pain syndromes, scapulocostal syndrome, and shoulder pain. The SPS muscle is located at the C7-T2 level. It attaches to the lateral edges of the second and fifth ribs. It is innervated by the lower cervical and upper intercostal nerves. With the SPS block, these nerves are blocked and analgesia is provided.

In the cadaveric study of Tulgar et al., it was determined that the spread of serratus posterior superior interfacial plane block; 7-10 intercostal levels on the left side only in the superficial fascia of the trapezius muscle. Spread dye was observed at intercostal levels, absent on the right. There was prominent staining on both sides of the deep trapezius muscle. Both the surface and skin of the rhomboid major were stained, while the rhomboid minor was only stained in the skin. SPSP block will provide successful analgesia in procedures involving the thoracic region such as chronic myofascial pain, breast surgery, thoracic surgery, and shoulder surgery. There is no randomized study in the literature evaluating the effectiveness of SPSP block for postoperative analgesia management after VATS.

In this study, we aim to evaluate the effectiveness of US-guided SPSP block for postoperative analgesia management after VATS. Our primary aim is to compare postoperative opioid consumption, our secondary aim is to evaluate postoperative pain scores (NRS), opioid-related side effects (allergic reaction, nausea, vomiting), and dermatome levels.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

There are two models for this study. The first group is the SPSIPB group. The second one is the control group.There are two models for this study. The first group is the SPSIPB group. The second one is the control group.

Masking:

Double (Participant, Outcomes Assessor)

Masking Description:

The anesthesiologist who performs postoperative pain evaluation and the patient will not know the group.

Primary Purpose:

Treatment

Official Title:

The Efficacy of Serratus Posterior Superior Interfacial Plane Block on Postoperative Analgesia in Patients Underwent Video-Assisted Thoracoscopic Surgery: A Randomized, Prospective, Controlled Study

Anticipated Study Start Date :

Aug 7, 2023

Anticipated Primary Completion Date :

Nov 20, 2023

Anticipated Study Completion Date :

Nov 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Group S = SPSIPB group A high-frequency linear US probe (11-12 MHz, Vivid Q) will be covered with a sterile sheath, and an 80 mm block needle (Braun 360°) will be used. The procedure will be performed with the patient in the lateral decubitus position. After the scapula is shifted slightly laterally, the US probe is placed sagittal at the upper corner of the spina scapula, and the serratus posterior superior muscle is visualized with the third rib. The in-plane technique will be used. The block needle will be advanced in the craniocaudal direction to enter between the serratus posterior superior and the third rib. The block location will be confirmed by injecting 5 ml of saline between the rib and the muscle. After the block location is confirmed, 30 ml of 0.25% concentration bupivacaine will be used.	Drug: Analgesia management; group S and C Patients will be administered ibuprofen 400 mgr IV every 8 hours in the postoperative period. A patient-controlled device prepared with 10 mcg/ ml fentanyl will be attached to all patients with a protocol including 10 mcg bolus without infusion dose, 10 min lockout time, and 4-hour limit. If the NRS score is ≥ 4, 0.5 mg kg-1 iv meperidine will be administered as a rescue analgesic. Postoperative patient evaluation will be performed by an anesthesiologist blinded to the procedure.
Other: Group C = Control group The intercostal infiltration with 30 ml of 0.25% concentration of bupivacaine will be performed by the surgical team.	Drug: Analgesia management; group S and C Patients will be administered ibuprofen 400 mgr IV every 8 hours in the postoperative period. A patient-controlled device prepared with 10 mcg/ ml fentanyl will be attached to all patients with a protocol including 10 mcg bolus without infusion dose, 10 min lockout time, and 4-hour limit. If the NRS score is ≥ 4, 0.5 mg kg-1 iv meperidine will be administered as a rescue analgesic. Postoperative patient evaluation will be performed by an anesthesiologist blinded to the procedure.

Arm

Intervention/Treatment

Placebo Comparator: Group S = SPSIPB group

A high-frequency linear US probe (11-12 MHz, Vivid Q) will be covered with a sterile sheath, and an 80 mm block needle (Braun 360°) will be used. The procedure will be performed with the patient in the lateral decubitus position. After the scapula is shifted slightly laterally, the US probe is placed sagittal at the upper corner of the spina scapula, and the serratus posterior superior muscle is visualized with the third rib. The in-plane technique will be used. The block needle will be advanced in the craniocaudal direction to enter between the serratus posterior superior and the third rib. The block location will be confirmed by injecting 5 ml of saline between the rib and the muscle. After the block location is confirmed, 30 ml of 0.25% concentration bupivacaine will be used.

Drug: Analgesia management; group S and C

Patients will be administered ibuprofen 400 mgr IV every 8 hours in the postoperative period. A patient-controlled device prepared with 10 mcg/ ml fentanyl will be attached to all patients with a protocol including 10 mcg bolus without infusion dose, 10 min lockout time, and 4-hour limit. If the NRS score is ≥ 4, 0.5 mg kg-1 iv meperidine will be administered as a rescue analgesic. Postoperative patient evaluation will be performed by an anesthesiologist blinded to the procedure.

Other: Group C = Control group

The intercostal infiltration with 30 ml of 0.25% concentration of bupivacaine will be performed by the surgical team.

Drug: Analgesia management; group S and C

Outcome Measures

Primary Outcome Measures

Opioid consumption (Fentanyl PCA) [Changes from baseline opioid consumption at postoperative 1, 2, 4, 8, 16 and 24 hours.]
The primary aim is to compare postoperative opioid consumption from the PCA device.

Secondary Outcome Measures

Pain scores (Numerical rating scale-NRS) [Changes from baseline pain scores at postoperative 1, 2, 4, 8, 16 and 24 hours]
The secondary aim is to compare NRS at the postoperative 24 h. Postoperative pain assessment will be performed using the NRS (0 = no pain, 10 = the most severe pain felt). The NRS scores will be recorded
Need for rescue analgesia (meperidine) [Postoperative 24 hours period]
The secondary aim is to compare rescue analgesia used in the postoperative 24 h.
Adverse events [Postoperative 24 hours period]
The secondary aim is to compare the adverse events (nausea, vomiting, itching) related to opioid use.

Other Outcome Measures

Dermatomal analyses [Postoperative 1st hour]
The secondary aim is to evaluate the dermatomal coverage of SPSIPB in Group S. The dermatomal coverage will be evaluated with a pinprick test.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

American Society of Anesthesiologists (ASA) classification I-III
Scheduled for VATS under general anesthesia

Exclusion Criteria:

history of bleeding diathesis,
receiving anticoagulant treatment,
known local anesthetics and opioid allergy,
infection of the skin at the site of the needle puncture,
pregnancy or lactation,
patients who do not accept the procedure

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Istanbul Medipol University Hospital	Istanbul	Bagcilar	Turkey	34070

Sponsors and Collaborators

Medipol University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Bahadir Ciftci, Primary researcher, Medipol University

ClinicalTrials.gov Identifier:

NCT05972122

Other Study ID Numbers:

Medipol Hospital 34

First Posted:

Aug 2, 2023

Last Update Posted:

Aug 2, 2023

Last Verified:

Jul 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Bahadir Ciftci, Primary researcher, Medipol University

VATS

Postoperative pain management

Serratus Posterior Superior Interfascial Plane Block

Additional relevant MeSH terms:

Lung Diseases

Study Results

No Results Posted as of Aug 2, 2023