Block and Erector Comparative Study Between Costotransverse Spinae Plane Block in Patients Undergoing Thoracotomy

NCT06301334 | Not Yet Recruiting

• 1 other identifier: Soh-Med-24-01-11MS
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

A thoracotomy requires a very painful incision, involving multiple muscle layers, rib resection and continuous motion as the patient breathes. Treatment of acute post thoracotomy pain is particularly important not only to keep the patient comfortable but also to minimize pulmonary complications Though epidural analgesia was once considered as the gold standard for post-thoracotomy pain management, it is not recommended for pain control after thoracotomy surgery because it is associated with high potential risks of dural puncture, nerve lesions, epidural hematoma and hypotension(4). Thoracic paravertebral block (TPVB) and intercostal nerve block are well described and recognized techniques for postoperative analgesia following thoracic surgeries, such as thoracotomy and mastectomy

Conditions

Pain Mangement of Thoracotomy

Outcome Measures

Primary Outcomes (1)

• study aims to compare the analgesic efficacy of CTB and ESPB for post-operative analgesia in patients undergoing thoracotomy.

  study aims to compare the analgesic efficacy of CTB and ESPB for post-operative analgesia in patients undergoing thoracotomyA standardized analgesic regimen will be prescribed in the post-operative period. All patients will receive paracetamol 1 gm every 6 h as routine analgesia. If visual analogue scale (VAS) is more than 3, intravenous morphine 3mg will be administered as rescue analgesia If visual analogue scale (VAS) is more than 5

  5months

Secondary Outcomes (1)

• The secondary outcome is the total postoperative morphine consumption, time of first analgesic,

  5months

Study Arms (2)

Group CTB

ACTIVE COMPARATOR

n=30): patients included in this group will receive unilateral US-guided CTB after general anesthesia. The CTB will be performed by using 20 ml bupivacaine 0.25%

Drug: Bupivacaine 0.25% Injectable Solution

Group ESPB

ACTIVE COMPARATOR

patients included in this group will receive unilateral US-guided ESPB after general anesthesia. The ESB will be performed by using 20 ml bupivacaine 0.25%

Drug: Bupivacaine 0.25% Injectable Solution

Interventions

Bupivacaine 0.25% Injectable Solution DRUG

Group CTB (n=30): patients included in this group will receive unilateral US-guided CTB after general anesthesia. The CTB will be performed by using 20 ml bupivacaine 0.25% Group ESPB (n=30): patients included in this group will receive unilateral US-guided ESPB after general anesthesia. The ESB will be performed by using 20 ml bupivacaine 0.25%

Group CTB; Group ESPB

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age from 18 to 75 years old.
• Both sexes.
• American Society of Anesthesiologists (ASA) physical status I-II-III.
• Patient undergoing unilateral thoracotomy surgery.

You may not qualify if:

• BMI more than 30 kg/m2.
• Patients who are taking analgesics for chronic illness or have a history of substance abuse.
• Patients who are unable to describe their postoperative pain (e.g., language barrier or neuropsychiatric disorder).
• Patients with a history of coagulopathy.
• Severe heart diseases.
• Hepatic or renal insufficiency.
• Infection at the site of infiltration

Sponsors & Collaborators

• Sohag University: lead

Related Publications (4)

• Mijatovic D, Bhalla T, Farid I. Post-thoracotomy analgesia. Saudi J Anaesth. 2021 Jul-Sep;15(3):341-347. doi: 10.4103/sja.SJA_743_20. Epub 2021 Jun 19.

  PMID: 34764841 BACKGROUND

• Liu Y, Xiao S, Yang H, Lv X, Hou A, Ma Y, Jiang Y, Duan C, Mi W; CAPOPS Group. Postoperative pain-related outcomes and perioperative pain management in China: a population-based study. Lancet Reg Health West Pac. 2023 Jun 10;39:100822. doi: 10.1016/j.lanwpc.2023.100822. eCollection 2023 Oct.

  PMID: 37927993 BACKGROUND

• Singariya G, Kamal M, Paliwal B. Pain after thoracotomy: Conquered or to be conquered? Indian J Anaesth. 2023 Feb;67(Suppl 1):S12-S14. doi: 10.4103/ija.ija_90_23. Epub 2023 Feb 10. No abstract available.

  PMID: 37065951 BACKGROUND

• Huang W, Wang W, Xie W, Chen Z, Liu Y. Erector spinae plane block for postoperative analgesia in breast and thoracic surgery: A systematic review and meta-analysis. J Clin Anesth. 2020 Nov;66:109900. doi: 10.1016/j.jclinane.2020.109900. Epub 2020 Jun 2.

  PMID: 32502778 BACKGROUND

MeSH Terms

Interventions

Bupivacaine

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Central Study Contacts

ahmed M mokhar, Resident

CONTACT

01121695985; ahmedmokhtar@med.sohag.edu.eg

wesam A Abo Elwafa Sallam, Assistant professor

CONTACT

01120623333

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident of anesthesia department, Sohag university hospital

Study Record Dates

• First Submitted: February 14, 2024
• First Posted: March 8, 2024
• Study Start: March 1, 2024
• Primary Completion: August 1, 2024
• Study Completion: August 1, 2024
• Last Updated: March 8, 2024

Record last verified: 2024-03