Comparison of the Effect of Preoperative and Postoperative ESP and PVB on Postoperative Pain in VATS

NCT06488014 | Completed Results

• 1 other identifier: CYGHG1
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this prospective controlled randomised clinical trial was to identify the analgesic method that is more effective than two different regional analgesia techniques routinely used for pain control after video-assisted thoracic surgery (VATS). The effects of paravertebral block and erector spina plan (ESP) block on acute pain, need for additional analgesics and incidence of chronic pain after video-assisted thoracic surgery (VATS) will be compared before surgical incision (pre-emptive) and at the end of surgery. The aim is to demonstrate that the ESP block, a relatively newer method in the literature, provides analgesia comparable to that of the paravertebral block.

Conditions

Anesthesia; Nerve Block; Pain, Postoperative; Thoracic Surgery, Video Assisted

Keywords

Anesthesia; Nerve Block; Postoperative PAİN; Video Assisted Thoracic Surgery (VATS)

Outcome Measures

Primary Outcomes (1)

• Acute Postoperative Pain (With NRS )

  Pain severity was assessed using the Numeric Rating Scale (NRS), an 11-point scale ranging from 0 (no pain) to 10 (worst pain imaginable).

  72 hours

Secondary Outcomes (1)

• Chronic Postoperative Pain

  postoperative 3. month, 6. month

Study Arms (2)

Group E

ACTIVE COMPARATOR

Erector spina plan block : Under USG guidance, local anaesthetic will be administered to the fascial plane between the erector spinae muscle and the transverse process.

Procedure: Erector spina plan block (ESP)

Group P

ACTIVE COMPARATOR

Paravertebral block: USG-guided local anaesthetic administration to the side of the vertebral body close to where the spinal nerves exit from the intervertebral foramen.

Procedure: Paravertebral block

Interventions

Erector spina plan block (ESP) PROCEDURE

In both groups, the relevant methods will be applied at the level of the surgical incision before the surgical incision (pre-emptive) after the patient is asleep and before the patient wakes up at the end of surgery. The dose of local anaesthetic to be administered is the same for both groups. Drug content to be administered\*: total 25 cc volume (13.5 ml 0.5% bupivacaine + 5 ml 2% lidocaine + 1.5 ml morphine (morphine diluted with 0.9% NaCl to 1mg/ml) + 5 ml 0.9% NaCl) (These doses are the routine doses applied in such surgeries in our clinic) \* Local anaesthetic drug doses in regional anaesthesia: source: Kirk, P. H. I. I. L. I. I. P. P., \& Berde, C. B. (2020). Local anaesthetics. Miller's Anaesthesia. 9th ed. Philadelphia: Elsevier Inc, 878-9.

Group E

Paravertebral block PROCEDURE

In both groups, the relevant methods will be applied at the level of the surgical incision before the surgical incision (pre-emptive) after the patient is asleep and before the patient wakes up at the end of surgery. The dose of local anaesthetic to be administered is the same for both groups. Drug content to be administered\*: total 25 cc volume (13.5 ml 0.5% bupivacaine + 5 ml 2% lidocaine + 1.5 ml morphine (morphine diluted with 0.9% NaCl to 1mg/ml) + 5 ml 0.9% NaCl) (These doses are the routine doses applied in such surgeries in our clinic) \* Local anaesthetic drug doses in regional anaesthesia: source: Kirk, P. H. I. I. L. I. I. P. P., \& Berde, C. B. (2020). Local anaesthetics. Miller's Anaesthesia. 9th ed. Philadelphia: Elsevier Inc, 878-9.

Group P

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>18 years
• ASA I-II
• Patients with a VATS (video-assisted thoracic surgery) plan

You may not qualify if:

• Under 18 years old
• Patients under 40kg and BMI over 35
• Allergic to the drugs to be used in the study
• Patients with a history of chronic painkiller use
• Patients who refused to participate in the study

Sponsors & Collaborators

• Ankara University: lead

Study Sites (1)

Ankara University

Ankara, Altındağ, 06340, Turkey (Türkiye)

Location

Related Publications (14)

• Clairoux, A., Issa, R., Bélanger, M. È., Urbanowicz, R., Richebé, P., & Brulotte, V. (2023). Perioperative pain management for thoracic surgery: a narrative review of the literature. Current Challenges in Thoracic Surgery, 5.

  BACKGROUND

• Makkad B, Heinke TL, Sheriffdeen R, Khatib D, Brodt JL, Meng ML, Grant MC, Kachulis B, Popescu WM, Wu CL, Bollen BA. Practice Advisory for Preoperative and Intraoperative Pain Management of Thoracic Surgical Patients: Part 1. Anesth Analg. 2023 Jul 1;137(1):2-25. doi: 10.1213/ANE.0000000000006441. Epub 2023 Apr 20.

  PMID: 37079466 BACKGROUND

• Lin J, Liao Y, Gong C, Yu L, Gao F, Yu J, Chen J, Chen X, Zheng T, Zheng X. Regional Analgesia in Video-Assisted Thoracic Surgery: A Bayesian Network Meta-Analysis. Front Med (Lausanne). 2022 Apr 6;9:842332. doi: 10.3389/fmed.2022.842332. eCollection 2022.

  PMID: 35463038 BACKGROUND

• Feray S, Lubach J, Joshi GP, Bonnet F, Van de Velde M; PROSPECT Working Group *of the European Society of Regional Anaesthesia and Pain Therapy. PROSPECT guidelines for video-assisted thoracoscopic surgery: a systematic review and procedure-specific postoperative pain management recommendations. Anaesthesia. 2022 Mar;77(3):311-325. doi: 10.1111/anae.15609. Epub 2021 Nov 5.

  PMID: 34739134 BACKGROUND

• Batchelor TJP, Rasburn NJ, Abdelnour-Berchtold E, Brunelli A, Cerfolio RJ, Gonzalez M, Ljungqvist O, Petersen RH, Popescu WM, Slinger PD, Naidu B. Guidelines for enhanced recovery after lung surgery: recommendations of the Enhanced Recovery After Surgery (ERAS(R)) Society and the European Society of Thoracic Surgeons (ESTS). Eur J Cardiothorac Surg. 2019 Jan 1;55(1):91-115. doi: 10.1093/ejcts/ezy301.

  PMID: 30304509 BACKGROUND

• Hamilton C, Alfille P, Mountjoy J, Bao X. Regional anesthesia and acute perioperative pain management in thoracic surgery: a narrative review. J Thorac Dis. 2022 Jun;14(6):2276-2296. doi: 10.21037/jtd-21-1740.

  PMID: 35813725 BACKGROUND

• Shim JG, Ryu KH, Kim PO, Cho EA, Ahn JH, Yeon JE, Lee SH, Kang DY. Evaluation of ultrasound-guided erector spinae plane block for postoperative management of video-assisted thoracoscopic surgery: a prospective, randomized, controlled clinical trial. J Thorac Dis. 2020 Aug;12(8):4174-4182. doi: 10.21037/jtd-20-689.

  PMID: 32944329 BACKGROUND

• Taketa Y, Irisawa Y, Fujitani T. Comparison of ultrasound-guided erector spinae plane block and thoracic paravertebral block for postoperative analgesia after video-assisted thoracic surgery: a randomized controlled non-inferiority clinical trial. Reg Anesth Pain Med. 2019 Nov 8:rapm-2019-100827. doi: 10.1136/rapm-2019-100827. Online ahead of print.

  PMID: 31704789 BACKGROUND

• Zhao H, Xin L, Feng Y. The effect of preoperative erector spinae plane vs. paravertebral blocks on patient-controlled oxycodone consumption after video-assisted thoracic surgery: A prospective randomized, blinded, non-inferiority study. J Clin Anesth. 2020 Jun;62:109737. doi: 10.1016/j.jclinane.2020.109737. Epub 2020 Feb 21.

  PMID: 32092617 BACKGROUND

• Chen N, Qiao Q, Chen R, Xu Q, Zhang Y, Tian Y. The effect of ultrasound-guided intercostal nerve block, single-injection erector spinae plane block and multiple-injection paravertebral block on postoperative analgesia in thoracoscopic surgery: A randomized, double-blinded, clinical trial. J Clin Anesth. 2020 Feb;59:106-111. doi: 10.1016/j.jclinane.2019.07.002. Epub 2019 Jul 19.

  PMID: 31330457 BACKGROUND

• Turhan O, Sivrikoz N, Sungur Z, Duman S, Ozkan B, Senturk M. Thoracic Paravertebral Block Achieves Better Pain Control Than Erector Spinae Plane Block and Intercostal Nerve Block in Thoracoscopic Surgery: A Randomized Study. J Cardiothorac Vasc Anesth. 2021 Oct;35(10):2920-2927. doi: 10.1053/j.jvca.2020.11.034. Epub 2020 Nov 20.

  PMID: 33358107 BACKGROUND

• Crile, G. (1913). The kinetic theory of shock and its prevention through anoci-association (shocklessoperation). The Lancet, 182(4688), 7-16.

  BACKGROUND

• Woolf CJ. Evidence for a central component of post-injury pain hypersensitivity. Nature. 1983 Dec 15-21;306(5944):686-8. doi: 10.1038/306686a0.

  PMID: 6656869 BACKGROUND

• Fuller AM, Bharde S, Sikandar S. The mechanisms and management of persistent postsurgical pain. Front Pain Res (Lausanne). 2023 Jul 6;4:1154597. doi: 10.3389/fpain.2023.1154597. eCollection 2023.

  PMID: 37484030 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Limitations and Caveats

Our main limitation is the lack of single-dose or no-block control groups, precluding definitive conclusions on the two-stage strategy's effect on CPSP. Future multicenter RCTs are needed. Additionally, adding morphine to the injectate is a potential confounder, though using identical solutions in both groups ensures valid intergroup comparisons. Despite these limits, our CPSP outcomes contribute valuable data to the current literature.

Results Point of Contact

• Title: MD. Hatice Güneş YEŞİOLVA
• Organization: Ankara University

htcguness@hotmail.com

+905510495354

Study Officials

• Çiğdem Yıldırım Güçlü, 1

  Ankara University

  STUDY DIRECTOR

• Hatice Güneş Yeşilova, 2

  Ankara University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research assistant

Model Details: Prospective randomised study -A sequence was created in which random blocks were assigned during the protocol phase according to the number of patients to be accepted for the study. The block type corresponding to the order in which patients were scheduled for surgery was applied. Group 1: Erector spinae plane block Group 2: Paravertebral block

Study Record Dates

• First Submitted: June 28, 2024
• First Posted: July 5, 2024
• Study Start: September 1, 2024
• Primary Completion: May 15, 2025
• Study Completion: July 30, 2025
• Last Updated: May 15, 2026
• Results First Posted: May 15, 2026

Record last verified: 2026-04

Locations

TU (1)