Postoperative PainNCT04555993
Erector Spinae vs TAP in Lower Abdominal Surgery
A study testing lower abdominal surgery, Erector spinae plane block and Transversus abdominis plane block in people with Postoperative Pain, run by National Cancer Institute, Egypt at 1 site in Egypt.
Trial summary
The aim of this study is to compare the analgesic effect and safety profile of erector spinae plane block with transverses abdominis plane block in controlling peri-operative pain for lower abdominal cancer surgery. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- lower abdominal surgery, Erector spinae plane block and Transversus abdominis plane block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteEgypt
- Study dates
- 28 Feb 2020to 15 Oct 2020
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Physical status ASA II.
- Age ≥ 18 and ≤ 65 Years.
- Cancer patients undergoing laparotomies for radical cystectomy or radical hysterectomy or low anterior resection (lower abdominal procedures).
- Patient is able to provide a written informed consent.
- Body mass index (BMI): > 20 kg/m2 and < 40 kg/m2.
Who cannot join
- Age <18 years or >65 years.
- BMI <20 kg/m2 and >40 kg/m2.
- Known sensitivity to local anaesthetics and morphine.
- History of psychological disorders and/or chronic pain.
- Significant liver or renal insufficiency.
- Contraindication to regional anaesthesia e.g. local sepsis, preexisting peripheral neuropathies and coagulopathy.
Show all 10Show fewer
- Patient refusal.
- Severe respiratory or cardiac disorders.
- Pregnancy.
- ASA III-IV.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison Between Ultrasound-Guided Transversus Abdominis Plane Block and Ultrasound-Guided Erector Spinae Plane Block in Postoperative Analgesia for Lower Abdominal Cancer Surgery. Randomised Double Blinded Control Study
The aim of this study is to compare the analgesic effect and safety profile of erector spinae plane block with transverses abdominis plane block in controlling peri-operative pain for lower abdominal cancer surgery.
Read the detailed description
Pain triggers a complex biochemical and physiological stress response leading to impairment of pulmonary, immunological and metabolic functions. Opioids are the current gold standard drug for postoperative pain relief, however exposure to large doses lead to multiple side effects of varying significance such as nausea, vomiting, dizziness, constipation, respiratory depression, hypoventilation and sleep breathing disorders. Therefore strategies other than opioids are recommended without sacrificing proper and effective analgesia. Especially in cancer patients who are more susceptible to tolerance and addiction.
The Transversus Abdominis Plane (TAP) block, is a regional anaesthesia technique used effectively in laparotomies. Unilateral analgesia to the skin, muscles, and parietal peritoneum of the anterior abdominal wall will be achieved without affecting visceral pain, when the anterior rami of the lower six thoracic nerves (T7-T12) and the first lumbar nerve (L1) are blocked.
Erector spinae plane block (ESPB) was shown to be an effective analgesic option for different types of surgeries. It's relatively a simple block, drug is injected in the plane between the erector spinae muscle and the vertebral transverse process. Blocking the ventral and dorsal rami of spinal nerves on the paravertebral area distributed from T2-T4 to L1-L2 and gives good coverage to visceral pain. Owing to the lower risk of blood vessel damage and neural damage compared to the epidural or the paravertebral block.
Both blocks haven't been compared to each other in this type of surgery before.
- Conditions
- Postoperative Pain
- Being tested
- lower abdominal surgery, Erector spinae plane block, Transversus abdominis plane block
- Keywords
- erector spinae block, TAP Block, abdominal surgery
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lower abdominal surgeryProcedure or surgery
Patients will undergo lower abdominal surgery under general anesthesia.
Erector spinae plane blockOther
patients will receive erector spinae plane block using 20 mL levobupivacaine (0.25%).
Transversus abdominis plane blockOther
patients will receive transversus abdominis plane block using 20 mL levobupivacaine (0.25%).
| Study group | Role | What they receive |
|---|---|---|
| Transversus abdomis plane block | Active comparator | Patients will receive Transversus abdomis plane block Receives: Procedure: lower abdominal surgery; Other: Transversus abdominis plane block |
| Erector spinae plane block | Experimental | Patients will receive Erector spinae plane block. Receives: Procedure: lower abdominal surgery; Other: Erector spinae plane block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total morphine consumption
The total amount of morphine which was consumed post-operatively measured in milligrams
Measured: 24 hours
Secondary outcomes (1)
Intraoperative fentanyl consumption.
The total amount of fentanyl which was consumed during the surgery measured in milligrams
Measured: intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2020
- Study start28 Feb 2020
- Primary completion1 Oct 2020 (estimated)
- Study completion15 Oct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Postoperative 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute, Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Shaban Mohammed, National Cancer Institute, Egypt
- Investigators
- waleed hamimy, Professor, Study chair, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04555993
- Sponsor's protocol ID
- MS-39-2019
- Status last verified
- Sep 2020
- First submitted
- 1 Sep 2020
- Last updated
- 21 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Randerath WJ, George S. Opioid-induced sleep apnea: is it a real problem? J Clin Sleep Med. 2012 Oct 15;8(5):577-8. doi: 10.5664/jcsm.2162. No abstract available.
PubMed 23066371Finnerty O, Carney J, McDonnell JG. Trunk blocks for abdominal surgery. Anaesthesia. 2010 Apr;65 Suppl 1:76-83. doi: 10.1111/j.1365-2044.2009.06203.x.
PubMed 20377549Hebbard P. Subcostal transversus abdominis plane block under ultrasound guidance. Anesth Analg. 2008 Feb;106(2):674-5; author reply 675. doi: 10.1213/ane.0b013e318161a88f. No abstract available.
PubMed 18227342Yarwood J, Berrill A (2010). Nerve blocks of the anterior abdominal wall, Continuing Education in Anaesthesia Critical Care & Pain, Vol10, Issue 6, pp 182-186.
Abrahams MS, Horn JL, Noles LM, Aziz MF. Evidence-based medicine: ultrasound guidance for truncal blocks. Reg Anesth Pain Med. 2010 Mar-Apr;35(2 Suppl):S36-42. doi: 10.1097/AAP.0b013e3181d32841.
PubMed 20216023Forero M, Adhikary SD, Lopez H, Tsui C, Chin KJ. The Erector Spinae Plane Block: A Novel Analgesic Technique in Thoracic Neuropathic Pain. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):621-7. doi: 10.1097/AAP.0000000000000451.
PubMed 27501016Chin KJ, Adhikary S, Sarwani N, Forero M. The analgesic efficacy of pre-operative bilateral erector spinae plane (ESP) blocks in patients having ventral hernia repair. Anaesthesia. 2017 Apr;72(4):452-460. doi: 10.1111/anae.13814. Epub 2017 Feb 11.
PubMed 28188621Forero M, Rajarathinam M, Adhikary S, Chin KJ. Continuous Erector Spinae Plane Block for Rescue Analgesia in Thoracotomy After Epidural Failure: A Case Report. A A Case Rep. 2017 May 15;8(10):254-256. doi: 10.1213/XAA.0000000000000478.
PubMed 28252539De Cassai A, Marchet A, Ori C. The combination of erector spinae plane block and pectoralis blocks could avoid general anesthesia for radical mastectomy in high risk patients. Minerva Anestesiol. 2018 Dec;84(12):1420-1421. doi: 10.23736/S0375-9393.18.13031-8. Epub 2018 Jul 9. No abstract available.
PubMed 29991225
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Ultrasound-Guided Transversus Abdominis Plane Block and Ultrasound-Guided Erector Spinae Plane Block in Postoperative Analgesia for Lower Abdominal Cancer Surgery. Randomised Double Blinded Control Study
- ClinicalTrials.gov ID
- NCT04555993
- Acronym / sponsor ID
- MS-39-2019
- Conditions
- Postoperative Pain
- Keywords
- erector spinae block, TAP Block, abdominal surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- National Cancer Institute, EgyptUniversity, hospital or other
- Study start
- 28 Feb 2020 (actual)
- Primary completion
- 1 Oct 2020 (estimated)
- Study completion
- 15 Oct 2020 (estimated)
- First posted
- 21 Sep 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.
The aim of this study is to compare the analgesic effect and safety profile of erector spinae plane block with transverses abdominis plane block in controlling peri-operative pain for lower abdominal cancer surgery.
Detailed description
Pain triggers a complex biochemical and physiological stress response leading to impairment of pulmonary, immunological and metabolic functions. Opioids are the current gold standard drug for postoperative pain relief, however exposure to large doses lead to multiple side effects of varying significance such as nausea, vomiting, dizziness, constipation, respiratory depression, hypoventilation and sleep breathing disorders. Therefore strategies other than opioids are recommended without sacrificing proper and effective analgesia. Especially in cancer patients who are more susceptible to tolerance and addiction.
The Transversus Abdominis Plane (TAP) block, is a regional anaesthesia technique used effectively in laparotomies. Unilateral analgesia to the skin, muscles, and parietal peritoneum of the anterior abdominal wall will be achieved without affecting visceral pain, when the anterior rami of the lower six thoracic nerves (T7-T12) and the first lumbar nerve (L1) are blocked.
Erector spinae plane block (ESPB) was shown to be an effective analgesic option for different types of surgeries. It's relatively a simple block, drug is injected in the plane between the erector spinae muscle and the vertebral transverse process. Blocking the ventral and dorsal rami of spinal nerves on the paravertebral area distributed from T2-T4 to L1-L2 and gives good coverage to visceral pain. Owing to the lower risk of blood vessel damage and neural damage compared to the epidural or the paravertebral block.
Both blocks haven't been compared to each other in this type of surgery before.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transversus abdomis plane block | Active comparator | Procedure: lower abdominal surgery, Other: Transversus abdominis plane blockPatients will receive Transversus abdomis plane block |
| Erector spinae plane block | Experimental | Procedure: lower abdominal surgery, Other: Erector spinae plane blockPatients will receive Erector spinae plane block. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Physical status ASA II.
- Age ≥ 18 and ≤ 65 Years.
- Cancer patients undergoing laparotomies for radical cystectomy or radical hysterectomy or low anterior resection (lower abdominal procedures).
- Patient is able to provide a written informed consent.
- Body mass index (BMI): > 20 kg/m2 and < 40 kg/m2.
Key exclusion criteria (10 listed)
- Age <18 years or >65 years.
- BMI <20 kg/m2 and >40 kg/m2.
- Known sensitivity to local anaesthetics and morphine.
- History of psychological disorders and/or chronic pain.
- Significant liver or renal insufficiency.
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 |
|---|---|---|
| lower abdominal surgeryPatients will undergo lower abdominal surgery under general anesthesia. | Procedure or surgery | Erector spinae plane block, Transversus abdomis plane block |
| Erector spinae plane blockpatients will receive erector spinae plane block using 20 mL levobupivacaine (0.25%). | Other | Erector spinae plane block |
| Transversus abdominis plane blockpatients will receive transversus abdominis plane block using 20 mL levobupivacaine (0.25%). | Other | Transversus abdomis plane block |
Primary outcome
Total morphine consumption
Time frame: 24 hours
The total amount of morphine which was consumed post-operatively measured in milligrams
1 secondary outcome
Intraoperative fentanyl consumption.
Time frame: intraoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2020.
- Background: PubMed 23066371Randerath WJ, George S. Opioid-induced sleep apnea: is it a real problem? J Clin Sleep Med. 2012 Oct 15;8(5):577-8. doi: 10.5664/jcsm.2162. No abstract available.
- Background: PubMed 20377549Finnerty O, Carney J, McDonnell JG. Trunk blocks for abdominal surgery. Anaesthesia. 2010 Apr;65 Suppl 1:76-83. doi: 10.1111/j.1365-2044.2009.06203.x.
- Background: PubMed 18227342Hebbard P. Subcostal transversus abdominis plane block under ultrasound guidance. Anesth Analg. 2008 Feb;106(2):674-5; author reply 675. doi: 10.1213/ane.0b013e318161a88f. No abstract available.
- BackgroundYarwood J, Berrill A (2010). Nerve blocks of the anterior abdominal wall, Continuing Education in Anaesthesia Critical Care & Pain, Vol10, Issue 6, pp 182-186.
- Background: PubMed 20216023Abrahams MS, Horn JL, Noles LM, Aziz MF. Evidence-based medicine: ultrasound guidance for truncal blocks. Reg Anesth Pain Med. 2010 Mar-Apr;35(2 Suppl):S36-42. doi: 10.1097/AAP.0b013e3181d32841.
- Background: PubMed 27501016Forero M, Adhikary SD, Lopez H, Tsui C, Chin KJ. The Erector Spinae Plane Block: A Novel Analgesic Technique in Thoracic Neuropathic Pain. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):621-7. doi: 10.1097/AAP.0000000000000451.
- Background: PubMed 28188621Chin KJ, Adhikary S, Sarwani N, Forero M. The analgesic efficacy of pre-operative bilateral erector spinae plane (ESP) blocks in patients having ventral hernia repair. Anaesthesia. 2017 Apr;72(4):452-460. doi: 10.1111/anae.13814. Epub 2017 Feb 11.
- Background: PubMed 28252539Forero M, Rajarathinam M, Adhikary S, Chin KJ. Continuous Erector Spinae Plane Block for Rescue Analgesia in Thoracotomy After Epidural Failure: A Case Report. A A Case Rep. 2017 May 15;8(10):254-256. doi: 10.1213/XAA.0000000000000478.
- Background: PubMed 29991225De Cassai A, Marchet A, Ori C. The combination of erector spinae plane block and pectoralis blocks could avoid general anesthesia for radical mastectomy in high risk patients. Minerva Anestesiol. 2018 Dec;84(12):1420-1421. doi: 10.23736/S0375-9393.18.13031-8. Epub 2018 Jul 9. No abstract available.
Related trials for Postoperative Pain
RecruitingPhase 4
Anrikefon-based Patient-controlled Intravenous Analgesia Following Laparoscopic Surgery
Laparoscopic Surgery, Visceral Pain, Postoperative
Recruiting
NOL Guided Analgesia During Elective Laparoscopic Surgery Under General Anesthesia
Intraoperative Analgesia
Recruiting
Aescin-Based Herbal Extract (Reparil) for Postoperative Sequelae After Mandibular Third Molar Surgery
Postoperative Pain, Facial Swelling
Recruiting
Effect of Ultrasonic and Diode Laser Activated Irrigation on Postoperative Pain Following Root Canal Treatment
Symptomatic Irreversible Pulpitis and Symptomatic Apical Periodontitis
Not yet recruiting
Opioid Reduction and Enhanced Recovery in Orthopaedic Surgery (OREOS)-Knee
Knee Arthroplasty, Total, Partial Knee Arthroplasty
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.
waleed hamimy, Professor study chair
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 lower abdominal surgery, Erector spinae plane block and Transversus abdominis plane block in people with Postoperative Pain, run by National Cancer Institute, Egypt 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 5 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 21 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. 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 ahmed hasanin, Professor (+201095076954, ahmedmohamedhasanin@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total morphine consumption (time frame: 24 hours). 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 NCT04555993, which also lists 9 linked publications.
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 21 Sep 2020.