Post Operative Pain, AcuteNCT05971368
A Comparative Study Between Ultrasound Guided Thoracic Paravertebral Block VS Serrartus Anterior Muscle Block in VATS as Regard Their Effectiveness in Post-operative Analgesia
A study testing thoracic paravertebal block and serratus anterior muscle block in people with Post Operative Pain, Acute, run by Ain Shams University at 1 site in Egypt.
Trial summary
A comparative study between ultrasound guided thoracic paravertebral block VS ultrasound guided serrartus anterior muscle block in video-assisted thoracoscopic surgeries as regard their effectiveness in post-operative analgesia Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Post Operative Pain, Acute
- What is being tested?
- thoracic paravertebal block and serratus anterior muscle block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 4 Jun 2022to 10 Feb 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients American Society of Anesthesiologists physical status (ASA) I to II
- Both sexes.
- Aged ≥ 20 to ≤ 65years.
- Scheduled for VATS under general anesthesia.
Who cannot join
- Patient's refusal.
- Patients American Society of Anesthesiologists physical status (ASA) III to IV
- Patients with major spine deformities.
- Disruption of the local anatomy, secondary, for instance, to the presence of chest drains or surgical emphysema, resulting in difficulty in ultrasound interpretation and distortion of tissue planes.
- Patients with bleeding disorders and coagulopathy.
- Infection at the injection site.
Show all 10Show fewer
- Known allergy to local anesthetics.
- Patients with pre-existing myopathy or neuropathy.
- Ipsilateral diaphragmatic paresis.
- Tumors in the paravertebral space at the level of injection.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of medicine Ain shams university
Cairo, Abbasia, 1181
faculty of medicine faculty of medicine ain shams university, +202-24346344, it@med.asu.edu.eg
Research Ethics Committee, (202)16857539, rec-fmasu@med.asu.edu.eg
About this study
Official title: A Comparative Study Between Ultrasound Guided Thoracic Paravertebral Block VS Ultrasound Guided Serrartus Anterior Muscle Block in Video-assisted Thoracoscopic Surgeries.
A comparative study between ultrasound guided thoracic paravertebral block VS ultrasound guided serrartus anterior muscle block in video-assisted thoracoscopic surgeries as regard their effectiveness in post-operative analgesia
Read the detailed description
The use of loco-regional analgesia is recommended to control postoperative pain after VATS as it allows opioid sparing and facilitates early postoperative rehabilitation. Different loco-regional analgesic techniques could be used to control pain after thoracic surgery such as a paravertebral block, an intercostal block and serratus plane block. In this study, Thoracic paravertebral nerve block will be compared to Serratus anterior nerve block, both will be done Ultrasound guided (USG) using bupivacaine (0.25%) for postoperative analgesia.
- Conditions
- Post Operative Pain, Acute
- Being tested
- thoracic paravertebal block, serratus anterior muscle block
- Keywords
- regional anesthesia
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
thoracic paravertebal blockProcedure or surgery
- Group A: Patients will receive ultrasound guided thoraxic paravertebral block with 0.25% bupivacaine 0.4 ml/kg (max. 40 ml and not exceeding toxic dose of bupivacaine 2.5mg/kg) after induction of anesthesia.
A high-frequency linear ultrasound probe will be placed between transverse processes from the T4 level (the level of port introduction) in the paramedian plane while patients is in the lateral decubitus position. The transverse processes, superior costotransverse ligaments, and pleura will be well visualized. The block needle (22 gauge) will be advanced until it crosses the superior costotransverse ligament. The prepared 0.25% bupivacaine will be administered at 0.4 mL/kg (max. 40 mL) in the thoracic paravertebral space. Depression of the pleura will be observed as a result of the spread of local anesthetic.
serratus anterior muscle blockProcedure or surgery
Group B: Patients will receive ultrasound guided serratus anterior muscle block with 0.25% bupivacaine 0.4 ml/kg (max. 40 ml and not exceeding toxic dose of bupivacaine 2.5mg/kg) after induction of anesthesia.
While the patient is in the supine position, a high-frequency linear ultrasound probe will be placed horizontally on the mid-axillary line at the level of 4th or 5th ribs on the side of the block. The serratus anterior, latissimus dorsi, and intercostal muscles will be identified. The block needle (22-gauge) will be advanced below the serratus anterior muscle (SAM) towards the fifth rib (using in-plane technique). The prepared 0.25% bupivacaine will be administered at 0.4 mL/kg (max. 40 mL) between the SAM and the rib. It will be observed that the solution of local anesthesia will spread between the SAM and the rib.
| Study group | Role | What they receive |
|---|---|---|
| Group A: Patients will receive ultrasound guided thoracic paravertebral block | Active comparator | Group A: Patients will receive ultrasound guided thoraxic paravertebral block with 0.25% bupivacaine 0.4 ml/kg (max. 40 ml and not exceeding toxic dose of bupivacaine 2.5mg/kg) after induction of anesthesia. Receives: Procedure: thoracic paravertebal block |
| Group B: Patients will receive ultrasound guided serratus anterior muscle block | Active comparator | Group B: Patients will receive ultrasound guided serratus anterior muscle block with 0.25% bupivacaine 0.4 ml/kg (max. 40 ml and not exceeding toxic dose of bupivacaine 2.5mg/kg) after induction of anesthesia. Receives: Procedure: serratus anterior muscle block |
What is being measured
The primary outcome is the main question the study is designed to answer.
total amount of opioid consumption in the two groups according to change in VAS score
Postoperative pain will be assessed at time of evaluation or at any time the patient is complaining of pain by using visual analog scale (VAS) and VAS more than 3 will be managed by injection of nalbuphine 0.05mg / kg intravenously as a first rescue analgesia to reduce VAS score ≤ 3 and another titrating dose (2-3 mg nalbuphine) will be considered if the patient is still complaining in order to reach VAS score ≤ 3 (with maximum dose of 10 mg nalbuphine at a time)
Measured: the first 24 hours postoperatively
visual analog scale (VAS)
Postoperative pain will be assessed at time of evaluation or at any time the patient is complaining of pain by using visual analog scale (VAS) and VAS more than 4 will be managed by injection of nalbuphine 5mg intravenously as a first rescue analgesia to reduce VAS score ≤ 3
Measured: the first 24 hours postoperatively
Secondary outcomes (5)
The onset of 1st analgesic request
Postoperative pain will be assessed by using visual analog scale (VAS) and VAS more than 4 will be managed by injection of nalbuphine 5mg intravenously as a first rescue analgesia to reduce VAS score ≤ 3. comparison will be done between the two groups in the onset of 1st analgesic request
Measured: The first 24 hours postoperatively
mean arterial blood pressure of the patients
After surgery, Patients will be observed immediately post-operative at 0 (PACU), and 2, 4, 8, 12, 24 hours after surgery for post-operative pain in form of increasing mean arterial blood pressure as a sign of uncontrolled pain
Measured: first 24 hours postoperatively
onset of ambulation
controlling pain postoperatively will help in early ambulation which is a major goal post operative to decrease complications
Measured: first 24 hours postoperatively
complication of nerve block
as hematoma , infection , pneumothorax .
Measured: first 24 hours postoperatively
heart rate of the patients
After surgery, Patients will be observed immediately post-operative at 0 (PACU), and 2, 4, 8, 12, 24 hours after surgery for post-operative pain in form of increasing heart rate above 90 (pulse per min )as a sign of uncontrolled pain
Measured: first 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2023
- Study start4 Jun 2022
- Primary completion4 Jan 2024
- Study completion10 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Operative Pain, AcuteStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05971368
- Sponsor's protocol ID
- paravertebral vs serratus
- Status last verified
- Jun 2023
- First submitted
- 16 Jun 2023
- Last updated
- 8 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study Between Ultrasound Guided Thoracic Paravertebral Block VS Ultrasound Guided Serrartus Anterior Muscle Block in Video-assisted Thoracoscopic Surgeries.
- ClinicalTrials.gov ID
- NCT05971368
- Acronym / sponsor ID
- paravertebral vs serratus
- Conditions
- Post Operative Pain, Acute
- Keywords
- regional anesthesia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 4 Jun 2022 (actual)
- Primary completion
- 4 Jan 2024 (actual)
- Study completion
- 10 Feb 2024 (estimated)
- First posted
- 2 Aug 2023 (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.
A comparative study between ultrasound guided thoracic paravertebral block VS ultrasound guided serrartus anterior muscle block in video-assisted thoracoscopic surgeries as regard their effectiveness in post-operative analgesia
Detailed description
The use of loco-regional analgesia is recommended to control postoperative pain after VATS as it allows opioid sparing and facilitates early postoperative rehabilitation. Different loco-regional analgesic techniques could be used to control pain after thoracic surgery such as a paravertebral block, an intercostal block and serratus plane block. In this study, Thoracic paravertebral nerve block will be compared to Serratus anterior nerve block, both will be done Ultrasound guided (USG) using bupivacaine (0.25%) for postoperative analgesia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: Patients will receive ultrasound guided thoracic paravertebral block | Active comparator | Procedure: thoracic paravertebal blockGroup A: Patients will receive ultrasound guided thoraxic paravertebral block with 0.25% bupivacaine 0.4 ml/kg (max. 40 ml and not exceeding toxic dose of bupivacaine 2.5mg/kg) after induction of anesthesia. |
| Group B: Patients will receive ultrasound guided serratus anterior muscle block | Active comparator | Procedure: serratus anterior muscle blockGroup B: Patients will receive ultrasound guided serratus anterior muscle block with 0.25% bupivacaine 0.4 ml/kg (max. 40 ml and not exceeding toxic dose of bupivacaine 2.5mg/kg) after induction of anesthesia. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients American Society of Anesthesiologists physical status (ASA) I to II
- Both sexes.
- Aged ≥ 20 to ≤ 65years.
- Scheduled for VATS under general anesthesia.
Key exclusion criteria (10 listed)
- Patient's refusal.
- Patients American Society of Anesthesiologists physical status (ASA) III to IV
- Patients with major spine deformities.
- Disruption of the local anatomy, secondary, for instance, to the presence of chest drains or surgical emphysema, resulting in difficulty in ultrasound interpretation and distortion of tissue planes.
- Patients with bleeding disorders and coagulopathy.
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 |
|---|---|---|
| thoracic paravertebal blocko Group A: Patients will receive ultrasound guided thoraxic paravertebral block with 0.25% bupivacaine 0.4 ml/kg (max. 40 ml and not exceeding toxic dose of bupivacaine 2.5mg/kg) after induction of anesthesia. A high-frequency linear ultrasound probe will be placed between transverse processes from the T4 level (the level of port introduction) in the paramedian plane while patients is in the lateral decubitus position. The transverse processes, superior costotransverse ligaments, and pleura will be well visualized. The block needle (22 gauge) will be advanced until it crosses the superior costotransverse ligament. The prepared 0.25% bupivacaine will be administered at 0.4 mL/kg (max. 40 mL) in the thoracic paravertebral space. Depression of the pleura will be observed as a result of the spread of local anesthetic. | Procedure or surgery | Group A: Patients will receive ultrasound guided thoracic paravertebral block |
| serratus anterior muscle blockGroup B: Patients will receive ultrasound guided serratus anterior muscle block with 0.25% bupivacaine 0.4 ml/kg (max. 40 ml and not exceeding toxic dose of bupivacaine 2.5mg/kg) after induction of anesthesia. While the patient is in the supine position, a high-frequency linear ultrasound probe will be placed horizontally on the mid-axillary line at the level of 4th or 5th ribs on the side of the block. The serratus anterior, latissimus dorsi, and intercostal muscles will be identified. The block needle (22-gauge) will be advanced below the serratus anterior muscle (SAM) towards the fifth rib (using in-plane technique). The prepared 0.25% bupivacaine will be administered at 0.4 mL/kg (max. 40 mL) between the SAM and the rib. It will be observed that the solution of local anesthesia will spread between the SAM and the rib. | Procedure or surgery | Group B: Patients will receive ultrasound guided serratus anterior muscle block |
Primary outcome
total amount of opioid consumption in the two groups according to change in VAS score
Time frame: the first 24 hours postoperatively
Postoperative pain will be assessed at time of evaluation or at any time the patient is complaining of pain by using visual analog scale (VAS) and VAS more than 3 will be managed by injection of nalbuphine 0.05mg / kg intravenously as a first rescue analgesia to reduce VAS score ≤ 3 and another titrating dose (2-3 mg nalbuphine) will be considered if the patient is still complaining in order to reach VAS score ≤ 3 (with maximum dose of 10 mg nalbuphine at a time)
visual analog scale (VAS)
Time frame: the first 24 hours postoperatively
Postoperative pain will be assessed at time of evaluation or at any time the patient is complaining of pain by using visual analog scale (VAS) and VAS more than 4 will be managed by injection of nalbuphine 5mg intravenously as a first rescue analgesia to reduce VAS score ≤ 3
5 secondary outcomes
The onset of 1st analgesic request
Time frame: The first 24 hours postoperatively
mean arterial blood pressure of the patients
Time frame: first 24 hours postoperatively
onset of ambulation
Time frame: first 24 hours postoperatively
complication of nerve block
Time frame: first 24 hours postoperatively
heart rate of the patients
Time frame: first 24 hours postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Post Operative Pain, Acute
Not yet recruiting
Two Bupivacaine Concentrations for Recto-Intercostal Fascial Plane Block After Laparoscopic Cholecystectomy
Postoperative Pain, Acute Pain
RecruitingPhase 1/2
A Study of CYT-1010 in Healthy Volunteers and Participants With Acute Pain After Third Molar Extraction
Acute Postoperative Pain, Dental Pain
Not yet recruiting
Post-operative Pain and Apical Healing After Root Canal (re)Treatment With Laser-activated Irrigation Versus Sonic or no Activation
Apical Periodontitis, Post Operative Pain, Acute
Not yet recruitingPhase 4
Suzetrigine (Journavx) as Multimodal Therapy for Pain Management in Adults Undergoing Surgery for Hip Fracture
Hip Fractures (ICD-10 72.01-72.2), Post Operative Analgesia
Recruiting
Rectus Sheath Catheters Following Midline Laparotomy
Acute Abdomen, Ileus
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing thoracic paravertebal block and serratus anterior muscle block in people with Post Operative Pain, Acute, 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 4 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 8 Feb 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact aya gamal abdelhamid, MSC ((202) 01067206719, ayagamal.3614@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
total amount of opioid consumption in the two groups according to change in VAS score (time frame: the first 24 hours postoperatively). The study lists 2 primary outcomes in all. 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 8 Feb 2024.