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出境医 / 临床实验 / Erector Spinae Plane Block Versus Transversus Abdominis Plane Block in Abdominoplasty Surgery

Erector Spinae Plane Block Versus Transversus Abdominis Plane Block in Abdominoplasty Surgery

Study Description
Brief 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. 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.


Condition or disease Intervention/treatment Phase
Abdominoplasty Procedure: Erector spinea plane block group Procedure: Transversus abdominis plane block Procedure: Control group Not Applicable

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
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 69 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: single-blind study
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Erector Spinae Plane Block: An Analgesic Technique as an Alternative to Transversus Abdominis Plane Block in Abdominoplasty Surgery
Actual Study Start Date : April 1, 2019
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : June 2021
Arms and Interventions
Arm Intervention/treatment
Active Comparator: Erector spinea plane block group
this group is planned for ultrasound-guided Transversus abdominis plane block
 Procedure: Erector spinea plane block group
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
Active Comparator: Transversus abdominis plane block
this group is planned for ultrasound-guided Transversus abdominis plane block
 Procedure: Transversus abdominis plane block
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
Placebo Comparator: Control group
standard general anesthesia
 Procedure: Control group
this group will receive only standard general anesthesia
Outcome Measures
Primary Outcome Measures :
  1. Total opioid consumption [ Time Frame: For 24 hours after performing block ]
    cumulative consumption of rescue opioids during the first postoperative day


Secondary Outcome Measures :
  1. Duration of analgesia [ Time Frame: for 24 hours after performing block ]
    the first time patient requests analgesia postoperatively

  2. Postoperative visual analogue score [ Time Frame: for 24 hours after performing block ]
    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

  3. Cortisol level [ Time Frame: For one hour after performing block ]
    Cortisol level will be assayed in the serum

  4. Heart rate [ Time Frame: For 24 hours after surgery ]
    Changes in heart rate

  5. Mean arterial blood pressure [ Time Frame: For 24 hours after surgery ]
    Changes in mean arterial blood pressure

  6. Peripheral oxygen saturation [ Time Frame: For 24 hours after surgery ]
    Changes in peripheral oxygen saturation as measured with pulse oximetry

  7. Nausea and vomiting [ Time Frame: For 24 hour after surgery ]
    0: No nausea, 1: mild nausea, 2: moderate nausea, 3: severe nausea or vomiting


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   25 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • American society of anesthesiologist grade I-II

Exclusion Criteria:

  • 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.
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Mona A Hasheesh, MD 01223912912947 drmonahasheesh@hotmail.com
Contact: Hanaa M Elbendary, MD 00201005781768 hanaa_elbendary@yahoo.com

Locations
Layout table for location information
Egypt
Hanaa M Elbendary Recruiting
Mansourah, DK, Egypt, 050
Contact: Hanaa M Elbendary, MD    00201005781768 ext 00201005781768    hanaa_elbendary@yahoo.com   
Contact: Mona A Hasheesh, MD       drmonahasheesh@hotmail.com   
Sub-Investigator: Tamer E Farahat, MD         
Sub-Investigator: Ayat E Eid, MD         
Sponsors and Collaborators
Mansoura University
Investigators
Layout table for investigator information
Study Chair: Hanaa M Elbendary, MD Anesthesia Department, Faculty of Medicine, Mansoura University
Tracking Information
First Submitted Date  ICMJE May 6, 2019
First Posted Date  ICMJE May 7, 2019
Last Update Posted Date September 25, 2020
Actual Study Start Date  ICMJE April 1, 2019
Estimated Primary Completion Date April 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 11, 2019) 		Total opioid consumption [ Time Frame: For 24 hours after performing block ]
cumulative consumption of rescue opioids during the first postoperative day
Original Primary Outcome Measures  ICMJE
 (submitted: May 6, 2019) 		Total opioid consumption [ Time Frame: For 24 hours after performing block ]
Cummulative consumption of rescue opioids during the first postoperative day
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 11, 2019)
  • Duration of analgesia [ Time Frame: for 24 hours after performing block ]
    the first time patient requests analgesia postoperatively
  • Postoperative visual analogue score [ Time Frame: for 24 hours after performing block ]
    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
  • Cortisol level [ Time Frame: For one hour after performing block ]
    Cortisol level will be assayed in the serum
  • Heart rate [ Time Frame: For 24 hours after surgery ]
    Changes in heart rate
  • Mean arterial blood pressure [ Time Frame: For 24 hours after surgery ]
    Changes in mean arterial blood pressure
  • Peripheral oxygen saturation [ Time Frame: For 24 hours after surgery ]
    Changes in peripheral oxygen saturation as measured with pulse oximetry
  • Nausea and vomiting [ Time Frame: For 24 hour after surgery ]
    0: No nausea, 1: mild nausea, 2: moderate nausea, 3: severe nausea or vomiting
Original Secondary Outcome Measures  ICMJE
 (submitted: May 6, 2019)
  • Duration of analgesia [ Time Frame: for 24 hours after performing block ]
    the first time patient requests analgesia postoperatively
  • Postoperative visual analogue score [ Time Frame: for 24 hours after performing block ]
    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. Diclophenac75 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 pethedine 25 mg IV
  • Cortisol level [ Time Frame: For one hour after performing block ]
    Cortisol level will be assayed in the serum
  • Heart rate [ Time Frame: For 24 hours after surgery ]
    Changes in heart rate
  • Mean arterial blood pressure [ Time Frame: For 24 hours after surgery ]
    Changes in mean arterial blood pressure
  • Peripheral oxygen saturation [ Time Frame: For 24 hours after surgery ]
    Changes in peripheral oxygen saturation as measured with pulse oximetry
  • Nausea and vomiting [ Time Frame: For 24 hour after surgery ]
    0: No nausea, 1: mild nausea, 2: moderate nausea, 3: severe nausea or vomiting
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Erector Spinae Plane Block Versus Transversus Abdominis Plane Block in Abdominoplasty Surgery
Official Title  ICMJE Erector Spinae Plane Block: An Analgesic Technique as an Alternative to Transversus Abdominis Plane Block in Abdominoplasty Surgery
Brief 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. 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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
single-blind study
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Condition  ICMJE Abdominoplasty
Intervention  ICMJE
  • Procedure: Erector spinea plane block group
    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
  • Procedure: Transversus abdominis plane block
    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
  • Procedure: Control group
    this group will receive only standard general anesthesia
Study Arms  ICMJE
  • Active Comparator: Erector spinea plane block group
    this group is planned for ultrasound-guided Transversus abdominis plane block
    Intervention: Procedure: Erector spinea plane block group
  • Active Comparator: Transversus abdominis plane block
    this group is planned for ultrasound-guided Transversus abdominis plane block
    Intervention: Procedure: Transversus abdominis plane block
  • Placebo Comparator: Control group
    standard general anesthesia
    Intervention: Procedure: Control group
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 6, 2019) 		69
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2021
Estimated Primary Completion Date April 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • American society of anesthesiologist grade I-II

Exclusion Criteria:

  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 25 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Mona A Hasheesh, MD 01223912912947 drmonahasheesh@hotmail.com
Contact: Hanaa M Elbendary, MD 00201005781768 hanaa_elbendary@yahoo.com
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03940885
Other Study ID Numbers  ICMJE MD.19.03.155
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Following completing recruiting and opening the dataset, the investigators would upload the raw data and results to the registry
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Time Frame: The data will become available following completing the study for life-long
Access Criteria: The data will be accessible to the investigators and PRS administrators with hiding the identifiers for the patients
Responsible Party Mansoura University
Study Sponsor  ICMJE Mansoura University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Hanaa M Elbendary, MD Anesthesia Department, Faculty of Medicine, Mansoura University
PRS Account Mansoura University
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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