Postoperative Analgesia After Video-Assisted Thoracoscopic Surgery

NCT06836635 | Completed DMC

• 1 other identifier: FMASU MS99/2024
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Video-assisted thoracoscopic surgery (VATS) is a commonly performed minimally invasive procedure that has lead to lower levels of pain. However, VATS require analgesia that blocks both visceral and somatic nerve fibers for more effective pain control. In this study investigators will compare the analgesic effect of ultrasound guided erector spinae plane block (ESPB) and thoracic paravertebral block (TPVB) after VATS.

Conditions

Postoperative Pain Management, After VATS

Keywords

Postoperative pain management

Outcome Measures

Primary Outcomes (1)

• To compare the post-operative morphine consumption in first 24 hours between ESPB and TPVB after VATS

  From injection to 24 hours postoperative

Secondary Outcomes (8)

• Post-operative pain severity assessed by visual analogue scale (VAS) (every 6 hr for 24 hr at rest and during cough).

  From injection to 24 hours postoperative

• Time of first request of rescue analgesia (rescue analgesia will be given in case of break through pain VAS ≥ 4 inform of 0.1mg/kg morphine).

  From injection to 24 hours postoperative

• Incidence of post-operative nausea and vomiting.

  From injection to 24 hours postoperative

• Incidence of complications (haematoma and pneumothorax).

  From injection to 24 hours postoperative

• Patient satisfaction during procedure (score 1-4 (1= very dissatisfied, 2= dissatisfied, 3= satisfied, 4= very satisfied)).

  From injection to 24 hours postoperative

Study Arms (2)

The ESPB group

EXPERIMENTAL

a high-frequency linear ultrasound probe will be placed in a longitudinal orientation 3 cm from the midline. Once the erector spinae muscle and the transverse processes identified, a 100mm needle (B- Braun Medical Inc., Bethlehem, PA, USA) will be inserted after standard skin disinfection in a caudad-to-cephalad direction using a sterile probe cover until the tip lay in the interfacial plane deep to the erector spinae muscle. After hydrolocalization with normal saline, this plane will be opened. 20 milliliters (mL) of 0.25% bupivacaine will be administered for block performance.

Procedure: ESPB group

The TPVB group

EXPERIMENTAL

A high-frequency linear ultrasound probe will be placed in a vertical orientation 23 cm lateral to the midline. Once the transverse process, internal intercostal membrane and parietal pleura identified, a 100mm needle (B- Braun Medical Inc., Bethlehem, PA, USA) will be inserted after standard skin disinfection laterally to medically Use a sterile probe cover until the tip lay in the thoracic paravertebral space beyond the internal intercostal membrane. After injection with normal saline, to confirm ventral pressing of the parietal pleura, 20 mL of 0.25% bupivacaine will be administered for block performance

Procedure: TPVB group

Interventions

ESPB group PROCEDURE

The patient will be placed in the lateral position. Block will be performed under complete aseptic precautions using ultrasound machine with high frequency linear probe covered with sterile sheath . The block will be performed at the T5-T6 level of the spine using an in-plane approach. Sensory block of the 5th intercostal space in the midaxillary line will be assessed by unilaterally using cold perception until 30 minutes after nerve block. If sensory blockade did not occur, the patient will be excluded from the study.

The ESPB group

TPVB group PROCEDURE

The patient will be placed in the lateral position. Block will be performed under complete aseptic precautions using ultrasound machine with high frequency linear probe covered with sterile sheath . The block will be performed at the T5-T6 level of the spine using an in-plane approach. Sensory block of the 5th intercostal space in the midaxillary line will be assessed by unilaterally using cold perception until 30 minutes after nerve block. If sensory blockade did not occur, the patient will be excluded from the study.

The TPVB group

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age eligible \>20 - \<70 yrs.
• Sex eligible both sex.
• Patients with American Society of Anesthesiologists (ASA) physical status 13 who will be scheduled for VATS, with three trochar ports. The trochar ports will be made at the fifth and sixth to intercostal levels. The chest drain will be inserted before the skin closure at the seventh or eighth intercostal level.

You may not qualify if:

• ≤20 or ≥70 years old.
• Declining to give written informed consent.
• History of allergy to the medications used in the study.
• Contraindication to regional anesthesia (including coagulopathy (platelet count ≤ 80,000, INR ≥ 1.5) and local infection).
• hepatic impairment (INR ≥1.5, Bilirubin ≥2, Albumin ≤2).
• Renal dysfunction (GFR \<50ml/min).
• Psychiatric disorder.
• Pregnancy.
• Body mass index (BMI) ≥40 or ≤18 kg/m2.
• VATS procedure converted to open.
• Patient with history of thoracic spine surgery.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain shams university

Cairo, Egypt, Egypt

Location

Study Officials

• Toka R Mohamed, M.B.B.CH

  Anesthesia resident at Ain shams university

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Post operative pain control

Study Record Dates

• First Submitted: January 5, 2025
• First Posted: February 20, 2025
• Study Start: March 10, 2024
• Primary Completion: August 20, 2024
• Study Completion: September 9, 2024
• Last Updated: February 20, 2025

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Access Criteria: Free

Locations

EG (1)