AbdominoplastyNCT03940885
Erector Spinae Plane Block Versus Transversus Abdominis Plane Block in Abdominoplasty Surgery
A study testing Erector spinea plane block group and Transversus abdominis plane block in people with Abdominoplasty, run by Mansoura University at 1 site in Egypt.
Trial summary
Abdominoplasty is one of the most popular body-contouring procedures. Patients that undergo body-contouring abdominoplasty usually have important analgesic requirements. Given the substantial incision and soft-tissue undermining associated with this procedure, postoperative pain is a concern for patients and surgeons. Read more about this study
- Who is it for?
- Ages 25 to 65 years
- Conditions the study is for
- Abdominoplasty
- What is being tested?
- Erector spinea plane block group and Transversus abdominis plane block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 69 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2019to Jun 2021
- 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 25 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American society of anesthesiologist grade I-II
Who cannot join
- Patient refusal.
- Local skin infection and sepsis at the site of the block.
- Allergy to local anesthetic used.
- Hematological diseases
- Bleeding disease.
- Coagulation abnormality.
- Psychiatric disorders.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Hanaa M Elbendary
Al Mansurah, DK, 050
Hanaa M Elbendary, MD, 00201005781768 ext. 00201005781768, hanaa_elbendary@yahoo.com
Mona A Hasheesh, MD, drmonahasheesh@hotmail.com
About this study
Official title: Erector Spinae Plane Block: An Analgesic Technique as an Alternative to Transversus Abdominis Plane Block in Abdominoplasty Surgery
Abdominoplasty is one of the most popular body-contouring procedures. Patients that undergo body-contouring abdominoplasty usually have important analgesic requirements. Given the substantial incision and soft-tissue undermining associated with this procedure, postoperative pain is a concern for patients and surgeons. Previous studies have typically incorporated multiple nerve blocks to improve analgesia after abdominoplasty. Different anesthetic techniques have been developed to overcome this problem such as Epidural anesthesia, Transversus abdominis plane block either open technique or ultrasound-guided, Paravertebral block and Erector Spinea plane block. Improving postoperative pain control in this kind of surgery leads to earlier mobilization, shortened hospital stay, reduced hospital costs, and increased patient satisfaction.
The ultrasound-guided erector spinae plane (ESP) block is a recent block described for various surgeries for postoperative analgesia. It is reported that it have an analgesic effect on somatic and visceral pain by affecting the ventral rami and rami communicantes that include sympathetic nerve fibres, as LA spreads through the paravertebral space. When performed bilaterally it has been reported to be as effective as thoracic epidural analgesia.
Read more
The transversus abdominis plane (TAP) block is a technique of locoregional anesthesia that blocks the sensorial afferent nerves localized between the transversus abdominis muscle and the internal oblique muscle.
In this study, the analgesic efficacy and duration of ultrasound (US) guided Erector spinea plane block and Transversus abdominis plane block when Lidocaine HCL is added as an adjuvant to bupivacaine will be compared.
Read the detailed description
Sample size was calculated using Power Analysis and Sample Size software program (PASS) version 15.0.5 for windows (2017) using previous results with the mean opioid consumption in the first postoperative day as the primary outcome. Effect size of 0.5 (medium effect size) was calculated using the difference between the mean opioid consumption in TAB group (140 mg) and that in ESPB group (124.6 mg) with an estimated standard deviation of 30 in both groups. This study will add a control group in which only intravenous analgesics will be used; hence the aforementioned effect size was used for sample size calculation using a one-way ANOVA test. Sample sizes of 18 patients in each group are needed to achieve 90% power (1-β) to detect differences among the means using an F test with a 0.05 significance level (α). The size of the variation in the means is represented by the effect size f = σm / σ, which is 0.5. A 20% drop out is expected so the drop-out inflated sample size will be 23 patients in each group.
- Conditions
- Abdominoplasty
- Being tested
- Erector spinea plane block group, Transversus abdominis plane block, Control group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erector spinea plane block groupProcedure or surgery
Which will receive ultrasound-guided erector spinea plane block bilaterally and the local anesthetic injected will be total volume 25 ml on each side consisting of 15ml of 0.5% plus 5 ml 2% lidocaine HCL plus 5 ml saline
Transversus abdominis plane blockProcedure or surgery
Which will receive ultrasound-guided Transversus Abdominis plane block bilaterally and the local anesthetic used will be total volume 25 ml on each side consisting of 15ml of 0.5% plus 5 ml 2% lidocaine HCL plus 5 ml saline
Control groupProcedure or surgery
this group will receive only standard general anesthesia
| Study group | Role | What they receive |
|---|---|---|
| Erector spinea plane block group | Active comparator | this group is planned for ultrasound-guided Transversus abdominis plane block Receives: Procedure: Erector spinea plane block group |
| Transversus abdominis plane block | Active comparator | this group is planned for ultrasound-guided Transversus abdominis plane block Receives: Procedure: Transversus abdominis plane block |
| Control group | Placebo comparator | standard general anesthesia Receives: Procedure: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total opioid consumption
cumulative consumption of rescue opioids during the first postoperative day
Measured: For 24 hours after performing block
Secondary outcomes (7)
Duration of analgesia
the first time patient requests analgesia postoperatively
Measured: for 24 hours after performing block
Postoperative visual analogue score
postoperative visual analogue score (VAS)which will be used to determine the postoperative pain levels in patients. ( 0 representing no pain and 10 is the worst imaginable pain) will be assessed at 2h, 4h,6h,12h,18h and 24h postoperative. Diclofenac75 mg IV and paracetamol 500 mg will be given to all patients in the three groups every 12 hours. If VAS is > 4 patient will receive pethidine 25 mg IV
Measured: for 24 hours after performing block
Cortisol level
Cortisol level will be assayed in the serum
Measured: For one hour after performing block
Heart rate
Changes in heart rate
Measured: For 24 hours after surgery
Mean arterial blood pressure
Changes in mean arterial blood pressure
Measured: For 24 hours after surgery
Peripheral oxygen saturation
Changes in peripheral oxygen saturation as measured with pulse oximetry
Measured: For 24 hours after surgery
Nausea and vomiting
0: No nausea, 1: mild nausea, 2: moderate nausea, 3: severe nausea or vomiting
Measured: For 24 hour after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2019
- Study start1 Apr 2019
- Primary completionApr 2021 (estimated)
- Study completionJun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AbdominoplastyStudies of the same condition, open and under way.
- More trials run by Mansoura 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- single-blind study
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 69 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hanaa M Elbendary, MD, Study chair, Anesthesia Department, Faculty of Medicine, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03940885
- Sponsor's protocol ID
- MD.19.03.155
- Status last verified
- Sep 2020
- First submitted
- 6 May 2019
- Last updated
- 25 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Following completing recruiting and opening the dataset, the investigators would upload the raw data and results to the registry
Publications
Mankikar MG, Sardesai SP, Ghodki PS. Ultrasound-guided transversus abdominis plane block for post-operative analgesia in patients undergoing caesarean section. Indian J Anaesth. 2016 Apr;60(4):253-7. doi: 10.4103/0019-5049.179451.
PubMed 27141108
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Erector Spinae Plane Block: An Analgesic Technique as an Alternative to Transversus Abdominis Plane Block in Abdominoplasty Surgery
- ClinicalTrials.gov ID
- NCT03940885
- Acronym / sponsor ID
- MD.19.03.155
- Conditions
- Abdominoplasty
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 69 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- Apr 2021 (estimated)
- Study completion
- Jun 2021 (estimated)
- First posted
- 7 May 2019 (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.
Abdominoplasty is one of the most popular body-contouring procedures. Patients that undergo body-contouring abdominoplasty usually have important analgesic requirements. Given the substantial incision and soft-tissue undermining associated with this procedure, postoperative pain is a concern for patients and surgeons. Previous studies have typically incorporated multiple nerve blocks to improve analgesia after abdominoplasty. Different anesthetic techniques have been developed to overcome this problem such as Epidural anesthesia, Transversus abdominis plane block either open technique or ultrasound-guided, Paravertebral block and Erector Spinea plane block. Improving postoperative pain control in this kind of surgery leads to earlier mobilization, shortened hospital stay, reduced hospital costs, and increased patient satisfaction.
The ultrasound-guided erector spinae plane (ESP) block is a recent block described for various surgeries for postoperative analgesia. It is reported that it have an analgesic effect on somatic and visceral pain by affecting the ventral rami and rami communicantes that include sympathetic nerve fibres, as LA spreads through the paravertebral space. When performed bilaterally it has been reported to be as effective as thoracic epidural analgesia.
The transversus abdominis plane (TAP) block is a technique of locoregional anesthesia that blocks the sensorial afferent nerves localized between the transversus abdominis muscle and the internal oblique muscle.
In this study, the analgesic efficacy and duration of ultrasound (US) guided Erector spinea plane block and Transversus abdominis plane block when Lidocaine HCL is added as an adjuvant to bupivacaine will be compared.
Detailed description
Sample size was calculated using Power Analysis and Sample Size software program (PASS) version 15.0.5 for windows (2017) using previous results with the mean opioid consumption in the first postoperative day as the primary outcome. Effect size of 0.5 (medium effect size) was calculated using the difference between the mean opioid consumption in TAB group (140 mg) and that in ESPB group (124.6 mg) with an estimated standard deviation of 30 in both groups. This study will add a control group in which only intravenous analgesics will be used; hence the aforementioned effect size was used for sample size calculation using a one-way ANOVA test. Sample sizes of 18 patients in each group are needed to achieve 90% power (1-β) to detect differences among the means using an F test with a 0.05 significance level (α). The size of the variation in the means is represented by the effect size f = σm / σ, which is 0.5. A 20% drop out is expected so the drop-out inflated sample size will be 23 patients in each group.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- single-blind study
| Arm | Type | Receives |
|---|---|---|
| Erector spinea plane block group | Active comparator | Procedure: Erector spinea plane block groupthis group is planned for ultrasound-guided Transversus abdominis plane block |
| Transversus abdominis plane block | Active comparator | Procedure: Transversus abdominis plane blockthis group is planned for ultrasound-guided Transversus abdominis plane block |
| Control group | Placebo comparator | Procedure: Control groupstandard general anesthesia |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- American society of anesthesiologist grade I-II
Key exclusion criteria (7 listed)
- Patient refusal.
- Local skin infection and sepsis at the site of the block.
- Allergy to local anesthetic used.
- Hematological diseases
- Bleeding disease.
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 |
|---|---|---|
| Erector spinea plane block groupWhich will receive ultrasound-guided erector spinea plane block bilaterally and the local anesthetic injected will be total volume 25 ml on each side consisting of 15ml of 0.5% plus 5 ml 2% lidocaine HCL plus 5 ml saline | Procedure or surgery | Erector spinea plane block group |
| Transversus abdominis plane blockWhich will receive ultrasound-guided Transversus Abdominis plane block bilaterally and the local anesthetic used will be total volume 25 ml on each side consisting of 15ml of 0.5% plus 5 ml 2% lidocaine HCL plus 5 ml saline | Procedure or surgery | Transversus abdominis plane block |
| Control groupthis group will receive only standard general anesthesia | Procedure or surgery | Control group |
Primary outcome
Total opioid consumption
Time frame: For 24 hours after performing block
cumulative consumption of rescue opioids during the first postoperative day
7 secondary outcomes
Duration of analgesia
Time frame: for 24 hours after performing block
Postoperative visual analogue score
Time frame: for 24 hours after performing block
Cortisol level
Time frame: For one hour after performing block
Heart rate
Time frame: For 24 hours after surgery
Mean arterial blood pressure
Time frame: For 24 hours after surgery
Peripheral oxygen saturation
Time frame: For 24 hours after surgery
Nausea and vomiting
Time frame: For 24 hour after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2020.
- Results publication: PubMed 27141108Mankikar MG, Sardesai SP, Ghodki PS. Ultrasound-guided transversus abdominis plane block for post-operative analgesia in patients undergoing caesarean section. Indian J Anaesth. 2016 Apr;60(4):253-7. doi: 10.4103/0019-5049.179451.
- Individual participant dataSharing planned: Yes. Following completing recruiting and opening the dataset, the investigators would upload the raw data and results to the registry
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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.
Hanaa M Elbendary, MD study chair
Anesthesia Department, Faculty of Medicine, Mansoura 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 Erector spinea plane block group and Transversus abdominis plane block in people with Abdominoplasty, run by Mansoura 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 1 inclusion and 7 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 25 Sep 2020. 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. Some participants in this study may receive a placebo. 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 Mona A Hasheesh, MD (01223912912947, drmonahasheesh@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total opioid consumption (time frame: For 24 hours after performing block). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03940885, which also lists 1 linked publication.
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 25 Sep 2020.