Postoperative Analgesia After Video-Assisted Thoracoscopic Surgery

Not Applicable

Completed

Conditions: Postoperative Pain Management, After VATS

Registration Number: NCT06836635

Lead Sponsor: Ain Shams University

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).

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 50

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
To compare the post-operative morphine consumption in first 24 hours between ESPB and TPVB after VATS	From injection to 24 hours postoperative

Secondary Outcome Measures

Name	Time	Method
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
Patient satisfaction after 1st post-operative day (score 1-4 (1= very dissatisfied, 2= dissatisfied, 3= satisfied, 4= very satisfied)).	From injection to 24 hours postoperative
Procedure time from scanning to injection of local anesthetic (LA) correctly.	From injection to 24 hours postoperative
Anesthesiologist satisfaction about simplicity of block or fear from complications (score 1-4 (1= very dissatisfied, 2= dissatisfied, 3= satisfied, 4= very satisfied))	From injection to 24 hours postoperative

Trial Locations

Locations (1): Ain shams university
🇪🇬
Cairo, Egypt