Postoperative Pain Management, After VATSNCT06836635
Postoperative Analgesia After Video-Assisted Thoracoscopic Surgery
A study testing ESPB group and TPVB group in people with Postoperative Pain Management, After VATS, run by Ain Shams University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Postoperative Pain Management, After VATS
- What is being tested?
- ESPB group and TPVB group
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Mar 2024to 9 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- ≤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).
Show all 11Show fewer
- Psychiatric disorder.
- Pregnancy.
- Body mass index (BMI) ≥40 or ≤18 kg/m2.
- VATS procedure converted to open.
- Patient with history of thoracic spine surgery.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Study Between Ultrasound-Guided Erector Spinae Plane Block and Thoracic Paravertebral Block for Postoperative Analgesia After Video-Assisted Thoracoscopic Surgery
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.
Read the 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).
- Being tested
- ESPB group, TPVB group
- Keywords
- Postoperative pain management
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ESPB groupProcedure or surgery
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.
TPVB groupProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Procedure: TPVB group |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the post-operative morphine consumption in first 24 hours between ESPB and TPVB after VATS
Measured: 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).
Measured: 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).
Measured: From injection to 24 hours postoperative
Incidence of post-operative nausea and vomiting.
Measured: From injection to 24 hours postoperative
Incidence of complications (haematoma and pneumothorax).
Measured: From injection to 24 hours postoperative
Patient satisfaction during procedure (score 1-4 (1= very dissatisfied, 2= dissatisfied, 3= satisfied, 4= very satisfied)).
Measured: 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)).
Measured: From injection to 24 hours postoperative
Procedure time from scanning to injection of local anesthetic (LA) correctly.
Measured: 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))
Measured: From injection to 24 hours postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2025
- Study start10 Mar 2024
- Primary completion20 Aug 2024
- Study completion9 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Pain Management, After VATSStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Post operative pain control
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Toka R Mohamed, M.B.B.CH, Principal investigator, Anesthesia resident at Ain shams university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06836635
- Sponsor's protocol ID
- FMASU MS99/2024
- Status last verified
- Mar 2024
- First submitted
- 5 Jan 2025
- Last updated
- 20 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All data will be shared
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between Ultrasound-Guided Erector Spinae Plane Block and Thoracic Paravertebral Block for Postoperative Analgesia After Video-Assisted Thoracoscopic Surgery
- ClinicalTrials.gov ID
- NCT06836635
- Acronym / sponsor ID
- FMASU MS99/2024
- Keywords
- Postoperative pain management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 10 Mar 2024 (actual)
- Primary completion
- 20 Aug 2024 (actual)
- Study completion
- 9 Sep 2024 (actual)
- First posted
- 20 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Post operative pain control
| Arm | Type | Receives |
|---|---|---|
| The ESPB group | Experimental | Procedure: ESPB groupa 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. |
| The TPVB group | Experimental | Procedure: TPVB groupA 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 |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (11 listed)
- ≤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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ESPB groupThe 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. | Procedure or surgery | The ESPB group |
| TPVB groupThe 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. | Procedure or surgery | The TPVB group |
Primary outcome
To compare the post-operative morphine consumption in first 24 hours between ESPB and TPVB after VATS
Time frame: From injection to 24 hours postoperative
8 secondary outcomes
Post-operative pain severity assessed by visual analogue scale (VAS) (every 6 hr for 24 hr at rest and during cough).
Time frame: 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).
Time frame: From injection to 24 hours postoperative
Incidence of post-operative nausea and vomiting.
Time frame: From injection to 24 hours postoperative
Incidence of complications (haematoma and pneumothorax).
Time frame: From injection to 24 hours postoperative
Patient satisfaction during procedure (score 1-4 (1= very dissatisfied, 2= dissatisfied, 3= satisfied, 4= very satisfied)).
Time frame: 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)).
Time frame: From injection to 24 hours postoperative
Procedure time from scanning to injection of local anesthetic (LA) correctly.
Time frame: 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))
Time frame: From injection to 24 hours postoperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2025.
- Individual participant dataSharing planned: Yes. All data will be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Toka R Mohamed, M.B.B.CH principal investigator
Anesthesia resident at Ain shams university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ESPB group and TPVB group in people with Postoperative Pain Management, After VATS, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To compare the post-operative morphine consumption in first 24 hours between ESPB and TPVB after VATS (time frame: From injection to 24 hours postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2025.