PainNCT04229420
Comparison of Ultrasound-Guided Bilateral Erector Spinae Plane Block Versus Bilateral Rectus Sheath Block in Adults Undergoing Major Abdominal Surgery
A study testing Ultrasound guided Rectus sheath block vs Erector spinae plane block in people with Pain and Postoperative, run by Kasr El Aini Hospital at 1 site in Egypt.
Trial summary
This randomized, controlled study is designed to assess the quality of analgesia provided by ultrasound guided ESPB versus RSB in adults undergoing major abdominal surgery. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- Ultrasound guided Rectus sheath block vs Erector spinae plane block
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2020to 1 Mar 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- ASA physical status I-II. Age: 18 to 60 years. Undergoing midline vertical laparotomy incisions (open colorectal resections or major ventral hernia repair).
Who cannot join
- Refusal of patients.
- Patients with coagulation disorders (Platelets ≤ 50,000 and/or INR> 1.5).
- History of allergic reactions to local anesthetics.
- Rash or signs of infection at the injection site.
- Emergency surgery.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Ultrasound-Guided Bilateral Erector Spinae Plane Block Versus Bilateral Rectus Sheath Block in Adults Undergoing Major Abdominal Surgery: a Randomized Comparative Study.
This randomized, controlled study is designed to assess the quality of analgesia provided by ultrasound guided ESPB versus RSB in adults undergoing major abdominal surgery.
Read the detailed description
Introduction:
Regional anesthesia is a key component of opioid-sparing multimodal analgesia after major abdominal surgery as it improves recovery such as return of bowel function and early ambulation. Continuous epidural local anesthetic infusion is a common analgesic technique but comes with the side effect of hypotension and potential leg weakness and rarely, epidural abscess or hematoma. The rectus sheath block (RSB) has been used for postoperative analgesia in surgical procedures involving a vertical midline laparotomy incision as well as for laparoscopic procedures. In this block the ventral rami of the seventh intercostal nerve up to the subcostal nerve, which supply the rectus abdominis muscle and overlying skin, are blocked.
Recently, the erector spinae plane block (ESPB) has gained wide attention due to its simplicity and potential uses in truncal procedures. This paraspinal plane block is performed by injecting local anesthetic between the erector spinae muscles and transverse processes and is thought to work by blocking the dorsal and ventral rami of the thoracic spinal nerves. Injections at various thoracic levels have been described in case reports with satisfactory postoperative analgesia for breast, thoracic and abdominal procedures. Comparison of post-operative pain management of both erector spinae plane block and rectus sheath block in adults undergoing major abdominal surgery for has not been investigated before.
Hypothesis:
It is hypothesized that ESPB is more effective in postoperative analgesia following major abdominal surgeries with minimal motor affection and postoperative morphine consumption compared to RSB block.
- Study Protocol:
On arrival of the patients to anesthesia room, patients will be secured with 20-gauge intravenous cannula and will receive midazolam 0.02mg/kg intravenous (IV), ondansetron (4 mg slowly IV).
Monitoring will include ECG, non-invasive arterial blood pressure, and pulse oximetry (SpO2).
All patients will receive a standardized anesthetic technique for induction with 2mcg/kg fentanyl, 2-3 mg/kg propofol, and 0.5 mg/kg atracurium. Mechanical ventilation will be adjusted to maintain an end tidal CO2 between (30 - 40 mmHg). Maintenance will be achieved with oxygen/air with isoflurane 1.2% and atracurium infusion at a dose of 0.5 mg/kg/h.
Following induction of anesthesia patients will be divided into two equal groups; Group 1 will receive pre-incisional ultrasound (US)-guided Bilateral RSB blocks using 20-ml volume of bupivacaine 0.25% for each side, and group 2 will receive pre-incisional ultrasound (US)-guided Bilateral ESPB using 20-ml volume of bupivacaine 0.25% for each side.
Group 1(RSB):
After preparing the skin with povidone iodine, a high frequency (5-10 MHz) ultrasound probe (S-NerveTM; SonoSite Inc., Bothell, WA, USA) will be placed in a longitudinal orientation above the level of the umbilicus with the Patient in the supine position. After identifying the rectus abdominis muscle, A 22 G echogenic needle using the in plane technique will be inserted just below the costal margin at an angle of approximately 45 degrees to the skin, then, a total of 20 ml of 0.25% bupivacaine will be injected into the plane between the rectus muscle and posterior rectus sheath. Negative aspiration will be confirmed every 5 ml. The block will then be repeated on the other side.
Group 2 (ESPB):
After induction of anesthesia; the patient will be positioned on the lateral position. The skin will be prepared with povidone iodine, and a high frequency (5-10 MHz) ultrasound probe (S-NerveTM; SonoSite Inc., Bothell, WA, USA) will be placed in a transverse orientation on the T9 spinous process which will be located by palpating and counting down from the C7 spinous process. The tip of the T9 transverse process will be identified and centred on the ultrasound screen, the probe will then be rotated into a longitudinal orientation to produce a parasagittal view, visible superficial to the acoustic shadows of the transverse processes: skin and subcutaneous tissue; trapezius; and erector spinae muscle .Correct location of the needle tip in the fascial plane deep to erector spinae muscle is confirmed by injecting 0.5-1 ml saline and seeing the fluid lifting the erector spinae muscle off the transverse process while not distending the muscle. A total of 20 ml of 0.25% bupivacaine will then be injected into the ESP of both sides. Negative aspiration will be confirmed every 5 ml].
Postoperative pain management:
Postoperatively, patients will receive 1 g paracetamol every 6 h and 30 mg ketorolac every 12 h.
If the visual analogue scale (VAS) is ≥ 4, a morphine increment (2-3 mg) IV that could be repeated every 5 minutes with a maximum dose of 15 mg per 4 hours or 45 mg per 24 hours will be added to maintain a resting VAS at <4 and the total 24 hours morphine consumption will be recorded.
- Conditions
- Pain, Postoperative
- Being tested
- Ultrasound guided Rectus sheath block vs Erector spinae plane block
- Keywords
- erector spinae, ultrasound, rectus sheath, pain
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound guided Rectus sheath block vs Erector spinae plane blockDevice
Ultrasound guided Rectus sheath block vs Erector spinae plane block
| Study group | Role | What they receive |
|---|---|---|
| Rectus sheath block group (RSB) | Active comparator | After preparing the skin, a high frequency (5-10 MHz) ultrasound probe will be placed in a longitudinal orientation above the level of the umbilicus with the Patient in the supine position. After identifying the rectus abdominis muscle, A 22 G echogenic needle using the in plane technique will be inserted just below the costal margin then, a total of 20 ml of 0.25% bupivacaine will be injected into the plane between the rectus muscle and posterior rectus sheath. Negative aspiration will be confirmed every 5 ml. The block will then be repeated on the other side. Receives: Device: Ultrasound guided Rectus sheath block vs Erector spinae plane block |
| Erector spinae plane block group (ESPB) | Active comparator | After induction of anesthesia; the patient will be positioned on the lateral position. The skin will be prepared with povidone iodine, and a high frequency (5-10 MHz) ultrasound probewill be placed in a transverse orientation on the T9 spinous process which will be located by palpating and counting down from the C7 spinous process. The tip of the T9 transverse process will be identified and centred on the ultrasound screen, the probe will then be rotated into a longitudinal orientation to produce a parasagittal view. Correct location of the needle tip in the fascial plane deep to erector spinae muscle is confirmed by injecting 0.5-1 ml saline and seeing the fluid lifting the erector spinae muscle off the transverse process while not distending the muscle. A total of 20 ml of 0.25% bupivacaine will then be injected into the ESP of both sides. Receives: Device: Ultrasound guided Rectus sheath block vs Erector spinae plane block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to first request of postoperative rescue analgesics
the time interval between the block performance and the first request to postoperative analgesia and or VAS ≥ 4
Measured: 24 hours
Secondary outcomes (5)
Visual analogue score at rest (static), and on movement or coughing (dynamic)
Visual analogue score at rest (static), and on movement or coughing (dynamic) at 30 and 60 minutes in the PACU then every 6 hours in the ward for 24 hours.
The visual analogue score is a continuous scale comprised of a horizontal (HVAS) or vertical (VVAS) line, usually 10 centimeters (100 mm) in length.
For pain intensity, the scale is most commonly anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 [100-mm scale])
Measured: 24 hours
Total consumption of morphine
total postoperative morphine consumption
Measured: 24 hours
Incidence of perioperative complications.
Incidence of perioperative complications(lower limb weakness, hematoma, viscus injury, intravascular injection and PONV
Measured: 24 hours
Block performance time in min
time from probe contact with skin till needle withdrawal.
Measured: procedure (time from probe contact with skin till needle withdrawal)
Failure rate of the block
will be calculated, where the block will be considered a failed block if the patient required more than two doses of rescue analgesia in the first hour postoperatively.
Measured: 1st postoperative hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2020
- Study start1 Jan 2020
- Primary completion1 Mar 2021
- Study completion1 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Study will be conducted on 60 adults aged from 18 to 60 years presented for major abdominal surgeries (open colorectal resections or major ventral hernia repair) at general surgery operating theatres, Cairo university hospitals. Patients will be divided into two equal groups; rectus sheath block group RSB (n=30) and erector spinae plane block group ESPB (n=30).
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kasr El Aini Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Khaled Abdelfattah Abdallah Sarhan, Kasr El Aini Hospital
- Investigators
- Khaled Sarhan, MD, Principal investigator, Lecturer of anesthesia, Cairo university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04229420
- Sponsor's protocol ID
- MD-33-2019
- Status last verified
- Mar 2021
- First submitted
- 12 Jan 2020
- Last updated
- 16 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- 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 16 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Ultrasound-Guided Bilateral Erector Spinae Plane Block Versus Bilateral Rectus Sheath Block in Adults Undergoing Major Abdominal Surgery: a Randomized Comparative Study.
- ClinicalTrials.gov ID
- NCT04229420
- Acronym / sponsor ID
- MD-33-2019
- Conditions
- Pain, Postoperative
- Keywords
- erector spinae, ultrasound, rectus sheath, pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Kasr El Aini HospitalUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 1 Mar 2021 (actual)
- Study completion
- 1 Mar 2021 (actual)
- First posted
- 18 Jan 2020 (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.
This randomized, controlled study is designed to assess the quality of analgesia provided by ultrasound guided ESPB versus RSB in adults undergoing major abdominal surgery.
Detailed description
Introduction:
Regional anesthesia is a key component of opioid-sparing multimodal analgesia after major abdominal surgery as it improves recovery such as return of bowel function and early ambulation. Continuous epidural local anesthetic infusion is a common analgesic technique but comes with the side effect of hypotension and potential leg weakness and rarely, epidural abscess or hematoma. The rectus sheath block (RSB) has been used for postoperative analgesia in surgical procedures involving a vertical midline laparotomy incision as well as for laparoscopic procedures. In this block the ventral rami of the seventh intercostal nerve up to the subcostal nerve, which supply the rectus abdominis muscle and overlying skin, are blocked.
Recently, the erector spinae plane block (ESPB) has gained wide attention due to its simplicity and potential uses in truncal procedures. This paraspinal plane block is performed by injecting local anesthetic between the erector spinae muscles and transverse processes and is thought to work by blocking the dorsal and ventral rami of the thoracic spinal nerves. Injections at various thoracic levels have been described in case reports with satisfactory postoperative analgesia for breast, thoracic and abdominal procedures. Comparison of post-operative pain management of both erector spinae plane block and rectus sheath block in adults undergoing major abdominal surgery for has not been investigated before.
Hypothesis:
It is hypothesized that ESPB is more effective in postoperative analgesia following major abdominal surgeries with minimal motor affection and postoperative morphine consumption compared to RSB block.
- Study Protocol:
On arrival of the patients to anesthesia room, patients will be secured with 20-gauge intravenous cannula and will receive midazolam 0.02mg/kg intravenous (IV), ondansetron (4 mg slowly IV).
Monitoring will include ECG, non-invasive arterial blood pressure, and pulse oximetry (SpO2).
All patients will receive a standardized anesthetic technique for induction with 2mcg/kg fentanyl, 2-3 mg/kg propofol, and 0.5 mg/kg atracurium. Mechanical ventilation will be adjusted to maintain an end tidal CO2 between (30 - 40 mmHg). Maintenance will be achieved with oxygen/air with isoflurane 1.2% and atracurium infusion at a dose of 0.5 mg/kg/h.
Following induction of anesthesia patients will be divided into two equal groups; Group 1 will receive pre-incisional ultrasound (US)-guided Bilateral RSB blocks using 20-ml volume of bupivacaine 0.25% for each side, and group 2 will receive pre-incisional ultrasound (US)-guided Bilateral ESPB using 20-ml volume of bupivacaine 0.25% for each side.
Group 1(RSB):
After preparing the skin with povidone iodine, a high frequency (5-10 MHz) ultrasound probe (S-NerveTM; SonoSite Inc., Bothell, WA, USA) will be placed in a longitudinal orientation above the level of the umbilicus with the Patient in the supine position. After identifying the rectus abdominis muscle, A 22 G echogenic needle using the in plane technique will be inserted just below the costal margin at an angle of approximately 45 degrees to the skin, then, a total of 20 ml of 0.25% bupivacaine will be injected into the plane between the rectus muscle and posterior rectus sheath. Negative aspiration will be confirmed every 5 ml. The block will then be repeated on the other side.
Group 2 (ESPB):
After induction of anesthesia; the patient will be positioned on the lateral position. The skin will be prepared with povidone iodine, and a high frequency (5-10 MHz) ultrasound probe (S-NerveTM; SonoSite Inc., Bothell, WA, USA) will be placed in a transverse orientation on the T9 spinous process which will be located by palpating and counting down from the C7 spinous process. The tip of the T9 transverse process will be identified and centred on the ultrasound screen, the probe will then be rotated into a longitudinal orientation to produce a parasagittal view, visible superficial to the acoustic shadows of the transverse processes: skin and subcutaneous tissue; trapezius; and erector spinae muscle .Correct location of the needle tip in the fascial plane deep to erector spinae muscle is confirmed by injecting 0.5-1 ml saline and seeing the fluid lifting the erector spinae muscle off the transverse process while not distending the muscle. A total of 20 ml of 0.25% bupivacaine will then be injected into the ESP of both sides. Negative aspiration will be confirmed every 5 ml].
Postoperative pain management:
Postoperatively, patients will receive 1 g paracetamol every 6 h and 30 mg ketorolac every 12 h.
If the visual analogue scale (VAS) is ≥ 4, a morphine increment (2-3 mg) IV that could be repeated every 5 minutes with a maximum dose of 15 mg per 4 hours or 45 mg per 24 hours will be added to maintain a resting VAS at <4 and the total 24 hours morphine consumption will be recorded.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Study will be conducted on 60 adults aged from 18 to 60 years presented for major abdominal surgeries (open colorectal resections or major ventral hernia repair) at general surgery operating theatres, Cairo university hospitals. Patients will be divided into two equal groups; rectus sheath block group RSB (n=30) and erector spinae plane block group ESPB (n=30).
| Arm | Type | Receives |
|---|---|---|
| Rectus sheath block group (RSB) | Active comparator | Device: Ultrasound guided Rectus sheath block vs Erector spinae plane blockAfter preparing the skin, a high frequency (5-10 MHz) ultrasound probe will be placed in a longitudinal orientation above the level of the umbilicus with the Patient in the supine position. After identifying the rectus abdominis muscle, A 22 G echogenic needle using the in plane technique will be inserted just below the costal margin then, a total of 20 ml of 0.25% bupivacaine will be injected into the plane between the rectus muscle and posterior rectus sheath. Negative aspiration will be confirmed every 5 ml. The block will then be repeated on the other side. |
| Erector spinae plane block group (ESPB) | Active comparator | Device: Ultrasound guided Rectus sheath block vs Erector spinae plane blockAfter induction of anesthesia; the patient will be positioned on the lateral position. The skin will be prepared with povidone iodine, and a high frequency (5-10 MHz) ultrasound probewill be placed in a transverse orientation on the T9 spinous process which will be located by palpating and counting down from the C7 spinous process. The tip of the T9 transverse process will be identified and centred on the ultrasound screen, the probe will then be rotated into a longitudinal orientation to produce a parasagittal view. Correct location of the needle tip in the fascial plane deep to erector spinae muscle is confirmed by injecting 0.5-1 ml saline and seeing the fluid lifting the erector spinae muscle off the transverse process while not distending the muscle. A total of 20 ml of 0.25% bupivacaine will then be injected into the ESP of both sides. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- ASA physical status I-II. Age: 18 to 60 years. Undergoing midline vertical laparotomy incisions (open colorectal resections or major ventral hernia repair).
Key exclusion criteria (5 listed)
- Refusal of patients.
- Patients with coagulation disorders (Platelets ≤ 50,000 and/or INR> 1.5).
- History of allergic reactions to local anesthetics.
- Rash or signs of infection at the injection site.
- Emergency surgery.
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 |
|---|---|---|
| Ultrasound guided Rectus sheath block vs Erector spinae plane blockUltrasound guided Rectus sheath block vs Erector spinae plane block | Device | Erector spinae plane block group (ESPB), Rectus sheath block group (RSB) |
Primary outcome
Time to first request of postoperative rescue analgesics
Time frame: 24 hours
the time interval between the block performance and the first request to postoperative analgesia and or VAS ≥ 4
5 secondary outcomes
Visual analogue score at rest (static), and on movement or coughing (dynamic)
Time frame: 24 hours
Total consumption of morphine
Time frame: 24 hours
Incidence of perioperative complications.
Time frame: 24 hours
Block performance time in min
Time frame: procedure (time from probe contact with skin till needle withdrawal)
Failure rate of the block
Time frame: 1st postoperative hour
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 16 Mar 2021.
- Individual participant dataSharing planned: Undecided
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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.
Khaled Sarhan, MD principal investigator
Lecturer of anesthesia, Cairo 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 Ultrasound guided Rectus sheath block vs Erector spinae plane block in people with Pain and Postoperative, run by Kasr El Aini Hospital 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 5 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 16 Mar 2021. 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?
Time to first request of postoperative rescue analgesics (time frame: 24 hours). 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 16 Mar 2021.