Clinical trial NCT06836635: Postoperative Analgesia After Video-Assisted Thoracoscopic Surgery
Official title: Comparative Study Between Ultrasound-Guided Erector Spinae Plane Block and Thoracic Paravertebral Block for Postoperative Analgesia After Video-Assisted Thoracoscopic Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain Management, After VATS
Keywords: Postoperative pain management
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2025-02-20
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Post operative pain control
Primary purpose: OTHER

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.

Detailed description: All patients will be assessed preoperatively by careful history taking, full physical examination, laboratory evaluation and other appropriate investigations.

At the preoperative visit, all patients will be instructed on how to evaluate their own pain by using a 10-cm visual analog pain scale (0= no pain, 10= maximum pain imaginable).

The nerve block will be performed in the preoperative block area following standardized monitoring, including noninvasive blood pressure (BP), electrocardiogram (ECG), and pulse oximetry (PO). Oxygen 23 L/min was applied through the nasal cannula, and midazolam 0.025 mg/kg iv, will be given.

All blocks will be performed by the same two experienced senior attending doctors in ultrasound-guided nerve blocks. Patients will be randomly assigned into one of the following groups using computer generated codes and closed opaque sealed envelopes and patient and anesthesiologist who collect data will not know which type of block administered (as block will be done in holding area):

Group 1 (TPVB group): patients will receive TPVB. Group 2 (ESPB group): patients will receive ESPB block. The patient will be placed in the lateral position. Both blocks will be performed under complete aseptic precautions using ultrasound machine with high frequency linear probe covered with sterile sheath .

The blocks will be performed unilateral at the T5-T6 level of the spine using an in-plane approach.

Pre-operative chest ultrasound will be done by the anesthesiologist to detect complications after the blockade (hematoma in the puncture site by direct visualization and pneumothorax by Barcode/Stratosphere sign).

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* ≤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.

Primary outcomes:
measure: To compare the post-operative morphine consumption in first 24 hours between ESPB and TPVB after VATS
timeFrame: From injection to 24 hours postoperative
Secondary outcomes:
measure: Post-operative pain severity assessed by visual analogue scale (VAS) (every 6 hr for 24 hr at rest and during cough).
timeFrame: From injection to 24 hours postoperative
measure: 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).
timeFrame: From injection to 24 hours postoperative
measure: Incidence of post-operative nausea and vomiting.
timeFrame: From injection to 24 hours postoperative
measure: Incidence of complications (haematoma and pneumothorax).
timeFrame: From injection to 24 hours postoperative
measure: Patient satisfaction during procedure (score 1-4 (1= very dissatisfied, 2= dissatisfied, 3= satisfied, 4= very satisfied)).
timeFrame: From injection to 24 hours postoperative
measure: Patient satisfaction after 1st post-operative day (score 1-4 (1= very dissatisfied, 2= dissatisfied, 3= satisfied, 4= very satisfied)).
timeFrame: From injection to 24 hours postoperative
measure: Procedure time from scanning to injection of local anesthetic (LA) correctly.
timeFrame: From injection to 24 hours postoperative
measure: Anesthesiologist satisfaction about simplicity of block or fear from complications (score 1-4 (1= very dissatisfied, 2= dissatisfied, 3= satisfied, 4= very satisfied))
timeFrame: From injection to 24 hours postoperative
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain shams university
Study officials:
affiliation: Anesthesia resident at Ain shams university
name: Toka R Mohamed, M.B.B.CH
role: PRINCIPAL_INVESTIGATOR
References: