Post-operative AnalgesiaNCT03965156
Bilateral Ultrasound Guided ESP Block Versus TAP Block on Post-operative Analgesia After Total Abdominal Hysterectomy
A study testing 1) Ultrasound guided Erector spinae block and Ultrasound guided transversus abdominis plane block in people with Post-operative Analgesia, run by Zagazig University at 1 site in Egypt.
Trial summary
Abdominal hysterectomy is an open surgical procedure associated with considerable post-operative pain. Narcotics are often required during patient recovery but can result in adverse side effects. Read more about this study
- Who is it for?
- Ages 40 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Post-operative Analgesia
- What is being tested?
- 1) Ultrasound guided Erector spinae block and Ultrasound guided transversus abdominis plane block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteEgypt
- Study dates
- 13 Jun 2019to 11 Oct 2019
- 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 40 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female Patient.
- Patient acceptance.
- Age (40-60) years old.
- American Society of Anaesthesiologist (ASA) I / II
- Elective total abdominal hysterectomy under general anesthesia.
- patient With Body Mass Index (BMI) (25-35kg/m²)
Who cannot join
- Patient refusal.
- Local infection at site of puncture.
- Altered mental status.
- History of allergy to study drugs ( bupivacaine, morphine).
- Patients with chronic pain.
- Patients with severe hepatic or kidney impairment.
- Patients having a history of hematological disorders, including coagulation abnormality.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Bilateral Ultrasound Guided Erector Spinae Plane Block Versus Transversus Abdominis Plane Block on Post-operative Analgesia After Total Abdominal Hysterectomy
- Abdominal hysterectomy is an open surgical procedure associated with considerable post-operative pain. Narcotics are often required during patient recovery but can result in adverse side effects. Transversus abdominis plane block(TAP block) is a regional anesthetic technique that is found to be effective as post-operative analgesia after total abdominal hysterectomy. Recently, erector spinae plane block(ESP)block is found to be safe, and simple regional anesthetic technique that decrease total opioid consumption in patient undergoing breast, or abdominal surgery.
- The aim is to compare the efficacy of bilateral erector spinae plane block, and bilateral transversus abdominis plane block on postoperative analgesia in patients after abdominal hysterectomy under general anesthesia, and their need for opioid.
Hypothesis
- Null hypothesis (H0): No difference between the analgesic effects of bilateral erector spinae plane block, and bilateral transversus abdominis plane block in patients after abdominal hysterectomy under general anesthesia.
- Alternative hypothesis (H1): There are difference between the analgesic effects of bilateral erector spinae plane block, and bilateral transversus abdominis plane block in patients after abdominal hysterectomy under general anesthesia.
Read the detailed description
Sample size: Assuming that Mean±SD of reduced pain scores in erector spinae plane block is 4.7±3.7 versus 2.5±1 in transversus abdominis plane block.So, the total sample size is 48 cases (24 in each group) using Open Source Statistics for Public Health (open Epi) with confidence interval 95% and power of test is 80%.
- Method of sample collection:
Forty eight female patients will be divided into two groups by a computer-generated randomization table:
Group (ES) (n=24): will receive bilateral ultrasound guided erector spinae plane block with each block 20 ml of bupivacaine 0.375% plus 5ug/ml adrenaline (1:200000) at the level of T9.
Group (TA) (n=24): will receive bilateral ultrasound guided transversus abdominis plane block with each block 20 ml of bupivacaine 0.375% plus 5ug/ml adrenaline (1:200000).
- Conditions
- Post-operative Analgesia
- Being tested
- 1) Ultrasound guided Erector spinae block, Ultrasound guided transversus abdominis plane block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1) Ultrasound guided Erector spinae blockProcedure or surgery
In the lateral position, after skin sterilization, erector spinae plane block will be performed at the level of T9. Counting down from the spine of seventh cervical vertebrae, the spine of the nine thoracic vertebrae (T9). A linear low frequency ultrasound transducer (US) (3-5 MHz) will placed sagittal 3cm lateral to midline to visualize the muscles of the back, transverse process and simmering pleura in between transverse processes. A 22-gauge short bevel needle will be inserted in cranial-caudal direction towards transverse process (TP) in plane to the US transducer until needle touched the TP crossing all the muscles. The location of the needle tip will be confirmed by visible normal saline fluid separating erector spinae muscle off the bony shadow of the transverse process on ultrasound imaging. Then 20 ml of bupivacaine 0.375% plus plus 5ug/ml adrenaline (1:200000) will be injected. The procedure will be repeated following the same steps on the other side of the back.
Ultrasound guided transversus abdominis plane blockProcedure or surgery
in supine position and after skin sterilization. The linear high frequency transducer (6-13 MHz) will be placed in the transverse plane to the the lateral abdominal wall in the midaxillary line, between the lower costal margin and iliac crest. The three abdominal wall muscles (external oblique, internal oblique, and transversus abdominis) are visualized. The needle inserted in plane and advanced anterior to posterior under continual visualization until the tip between the internal oblique and the transversus abdominis muscle. After negative aspiration, a 20 ml of bupivacaine 0.375% plus 5ug/ml adrenaline (1:200000) will be injected. The success of the injection will be confirmed by separation of the internal oblique and transversus abdominis with a distinct pocket of local anesthetic in between. The procedure will be repeated following the same steps on the other side.
| Study group | Role | What they receive |
|---|---|---|
| Erector Spinae Plane Block | Active comparator | Bilateral Ultrasound Guided Erector Spinae Plane Block Receives: Procedure: 1) Ultrasound guided Erector spinae block |
| transversus abdominis plane block | Active comparator | Ultrasound guided transversus abdominis plane block Receives: Procedure: Ultrasound guided transversus abdominis plane block |
What is being measured
The primary outcome is the main question the study is designed to answer.
The total amount of morphine given to each patient
The total amount of morphine given to each patient during the first 24h of postoperative period
Measured: the first 24 hours postoperative.
The time to first call to analgesia (morphine)
morphine (rescue analgesic) will be given if VAS>3.
Measured: first call to morphine up to 24 hours postoperative.
Pain intensity using Visual analogue Scale (VAS) (McCormack et al., 1988).
1- Pain intensity using Visual analogue Scale (VAS) (McCormack et al., 1988). A commonly used visual analog scale is a 10-cm line labeled with "worst pain imaginable" on the right border and "no pain" on the left border. The patient is instructed to make a mark along the line to represent the intensity of pain currently being experienced. VAS score will be assessed at 30 minutes, 2hs, 4hs, 6hs, 12hs, and 24hs postoperative and IV increment of 3mg morphine (rescue analgesic) will be given if VAS>3.
Measured: at 30 minutes postoperative.
Pain intensity using Visual analogue Scale (VAS)
visual analogue scale is a 10-cm line labeled with "worst pain imaginable" on the right border and "no pain" on the left border.
Measured: at 2 hours postoperative.
Pain intensity using Visual analogue Scale (VAS)
visual analogue scale is a 10-cm line labeled with "worst pain imaginable" on the right border and "no pain" on the left border.
Measured: at 4 hours postoperative.
Pain intensity using Visual analogue Scale (VAS)
visual analogue scale is a 10-cm line labeled with "worst pain imaginable" on the right border and "no pain" on the left border.
Measured: at 6 hours postoperative.
Pain intensity using Visual analogue Scale (VAS)
visual analogue scale is a 10-cm line labeled with "worst pain imaginable" on the right border and "no pain" on the left border.
Measured: at 12 hours postoperative.
Pain intensity using Visual analogue Scale (VAS)
visual analogue scale is a 10-cm line labeled with "worst pain imaginable" on the right border and "no pain" on the left border.
Measured: at 24 hours postoperative.
"Number of Participants with nausea, Vomiting, nausea or vomiting, hypotension, bradycardia, or any other complication"
"Number of Participants with nausea, Vomiting, nausea or vomiting, hypotension, bradycardia, or any other complication"
Measured: Up to 24 hours postoperative.
Secondary outcomes (1)
Over all patient satisfaction
Over all patient satisfaction:The patients will be asked to rate the overall degree of satisfaction of the analgesia using a 1-3 verbal scale (1 = unsatisfactory analgesia, 2 = satisfactory analgesia, and 3 = excellent analgesia) (Ross et al., 2009).
Measured: all over 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 posted28 May 2019
- Study start13 Jun 2019
- Primary completion1 Oct 2019
- Study completion11 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-operative AnalgesiaStudies of the same condition, open and under way.
- More trials run by Zagazig 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Alshaimaa Abdel Fattah Kamel, Zagazig University
- Investigators
- Alshaimaa Kamel, M.D, Principal investigator, faculty of medicine ,zagazig universty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03965156
- Sponsor's protocol ID
- 5423
- Status last verified
- Oct 2019
- First submitted
- 23 May 2019
- Last updated
- 17 Oct 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bilateral Ultrasound Guided Erector Spinae Plane Block Versus Transversus Abdominis Plane Block on Post-operative Analgesia After Total Abdominal Hysterectomy
- ClinicalTrials.gov ID
- NCT03965156
- Acronym / sponsor ID
- 5423
- Conditions
- Post-operative Analgesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 13 Jun 2019 (actual)
- Primary completion
- 1 Oct 2019 (actual)
- Study completion
- 11 Oct 2019 (actual)
- First posted
- 28 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.
- Abdominal hysterectomy is an open surgical procedure associated with considerable post-operative pain. Narcotics are often required during patient recovery but can result in adverse side effects. Transversus abdominis plane block(TAP block) is a regional anesthetic technique that is found to be effective as post-operative analgesia after total abdominal hysterectomy. Recently, erector spinae plane block(ESP)block is found to be safe, and simple regional anesthetic technique that decrease total opioid consumption in patient undergoing breast, or abdominal surgery.
- The aim is to compare the efficacy of bilateral erector spinae plane block, and bilateral transversus abdominis plane block on postoperative analgesia in patients after abdominal hysterectomy under general anesthesia, and their need for opioid.
Hypothesis
- Null hypothesis (H0): No difference between the analgesic effects of bilateral erector spinae plane block, and bilateral transversus abdominis plane block in patients after abdominal hysterectomy under general anesthesia.
- Alternative hypothesis (H1): There are difference between the analgesic effects of bilateral erector spinae plane block, and bilateral transversus abdominis plane block in patients after abdominal hysterectomy under general anesthesia.
Detailed description
Sample size: Assuming that Mean±SD of reduced pain scores in erector spinae plane block is 4.7±3.7 versus 2.5±1 in transversus abdominis plane block.So, the total sample size is 48 cases (24 in each group) using Open Source Statistics for Public Health (open Epi) with confidence interval 95% and power of test is 80%.
- Method of sample collection:
Forty eight female patients will be divided into two groups by a computer-generated randomization table:
Group (ES) (n=24): will receive bilateral ultrasound guided erector spinae plane block with each block 20 ml of bupivacaine 0.375% plus 5ug/ml adrenaline (1:200000) at the level of T9.
Group (TA) (n=24): will receive bilateral ultrasound guided transversus abdominis plane block with each block 20 ml of bupivacaine 0.375% plus 5ug/ml adrenaline (1:200000).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Erector Spinae Plane Block | Active comparator | Procedure: 1) Ultrasound guided Erector spinae blockBilateral Ultrasound Guided Erector Spinae Plane Block |
| transversus abdominis plane block | Active comparator | Procedure: Ultrasound guided transversus abdominis plane blockUltrasound guided transversus abdominis plane block |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Female Patient.
- Patient acceptance.
- Age (40-60) years old.
- American Society of Anaesthesiologist (ASA) I / II
- Elective total abdominal hysterectomy under general anesthesia.
Key exclusion criteria (7 listed)
- Patient refusal.
- Local infection at site of puncture.
- Altered mental status.
- History of allergy to study drugs ( bupivacaine, morphine).
- Patients with chronic pain.
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 |
|---|---|---|
| 1) Ultrasound guided Erector spinae blockIn the lateral position, after skin sterilization, erector spinae plane block will be performed at the level of T9. Counting down from the spine of seventh cervical vertebrae, the spine of the nine thoracic vertebrae (T9). A linear low frequency ultrasound transducer (US) (3-5 MHz) will placed sagittal 3cm lateral to midline to visualize the muscles of the back, transverse process and simmering pleura in between transverse processes. A 22-gauge short bevel needle will be inserted in cranial-caudal direction towards transverse process (TP) in plane to the US transducer until needle touched the TP crossing all the muscles. The location of the needle tip will be confirmed by visible normal saline fluid separating erector spinae muscle off the bony shadow of the transverse process on ultrasound imaging. Then 20 ml of bupivacaine 0.375% plus plus 5ug/ml adrenaline (1:200000) will be injected. The procedure will be repeated following the same steps on the other side of the back. | Procedure or surgery | Erector Spinae Plane Block |
| Ultrasound guided transversus abdominis plane blockin supine position and after skin sterilization. The linear high frequency transducer (6-13 MHz) will be placed in the transverse plane to the the lateral abdominal wall in the midaxillary line, between the lower costal margin and iliac crest. The three abdominal wall muscles (external oblique, internal oblique, and transversus abdominis) are visualized. The needle inserted in plane and advanced anterior to posterior under continual visualization until the tip between the internal oblique and the transversus abdominis muscle. After negative aspiration, a 20 ml of bupivacaine 0.375% plus 5ug/ml adrenaline (1:200000) will be injected. The success of the injection will be confirmed by separation of the internal oblique and transversus abdominis with a distinct pocket of local anesthetic in between. The procedure will be repeated following the same steps on the other side. | Procedure or surgery | transversus abdominis plane block |
Primary outcome
The total amount of morphine given to each patient
Time frame: the first 24 hours postoperative.
The total amount of morphine given to each patient during the first 24h of postoperative period
The time to first call to analgesia (morphine)
Time frame: first call to morphine up to 24 hours postoperative.
morphine (rescue analgesic) will be given if VAS>3.
Pain intensity using Visual analogue Scale (VAS) (McCormack et al., 1988).
Time frame: at 30 minutes postoperative.
1- Pain intensity using Visual analogue Scale (VAS) (McCormack et al., 1988). A commonly used visual analog scale is a 10-cm line labeled with "worst pain imaginable" on the right border and "no pain" on the left border. The patient is instructed to make a mark along the line to represent the intensity of pain currently being experienced. VAS score will be assessed at 30 minutes, 2hs, 4hs, 6hs, 12hs, and 24hs postoperative and IV increment of 3mg morphine (rescue analgesic) will be given if VAS>3.
Pain intensity using Visual analogue Scale (VAS)
Time frame: at 2 hours postoperative.
visual analogue scale is a 10-cm line labeled with "worst pain imaginable" on the right border and "no pain" on the left border.
Pain intensity using Visual analogue Scale (VAS)
Time frame: at 4 hours postoperative.
visual analogue scale is a 10-cm line labeled with "worst pain imaginable" on the right border and "no pain" on the left border.
Pain intensity using Visual analogue Scale (VAS)
Time frame: at 6 hours postoperative.
visual analogue scale is a 10-cm line labeled with "worst pain imaginable" on the right border and "no pain" on the left border.
Pain intensity using Visual analogue Scale (VAS)
Time frame: at 12 hours postoperative.
visual analogue scale is a 10-cm line labeled with "worst pain imaginable" on the right border and "no pain" on the left border.
Pain intensity using Visual analogue Scale (VAS)
Time frame: at 24 hours postoperative.
visual analogue scale is a 10-cm line labeled with "worst pain imaginable" on the right border and "no pain" on the left border.
"Number of Participants with nausea, Vomiting, nausea or vomiting, hypotension, bradycardia, or any other complication"
Time frame: Up to 24 hours postoperative.
"Number of Participants with nausea, Vomiting, nausea or vomiting, hypotension, bradycardia, or any other complication"
1 secondary outcome
Over all patient satisfaction
Time frame: all over 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 17 Oct 2019.
- Individual participant dataSharing planned: No
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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.
Alshaimaa Kamel, M.D principal investigator
faculty of medicine ,zagazig universty
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 1) Ultrasound guided Erector spinae block and Ultrasound guided transversus abdominis plane block in people with Post-operative Analgesia, run by Zagazig 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 6 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: finished, as of the sponsor's last update on 17 Oct 2019. 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?
The total amount of morphine given to each patient (time frame: the first 24 hours postoperative.). The study lists 9 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 17 Oct 2019.