Colo-rectal CancerNCT06957574
Erector Spinae Plane Block as Analgesia in Patients for Colectomy
A study testing Bubpivacaine in people with Colo-rectal Cancer, run by Suez Canal University at 1 site in Egypt.
Trial summary
Management of postoperative pain relief is largely inadequate. Despite the recent advances in pain management, postoperative pain incidence has not decreased; most patients still experience severe pain after major surgery. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Colo-rectal Cancer
- What is being tested?
- Bubpivacaine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2021to 15 Dec 2024
- 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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients of colorectal carcinoma scheduled for elective colectomy
Who cannot join
- Patients with a body mass index (BMI) of 35 kg/m2 or above
- patients with a history of hepatic or renal diseases
- patients with second- or third-degree heart blocks
- patients with coagulopathies
- patients with history of hypersensitivity to local anesthetics
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Erector Spinae Plane Block as Analgesia in Patients for Colectomy: A Randomized Controlled Study
Management of postoperative pain relief is largely inadequate. Despite the recent advances in pain management, postoperative pain incidence has not decreased; most patients still experience severe pain after major surgery. Poorly or inadequately controlled pain was reported to be linked to prolonged hospitalization, decreased patient satisfaction, the risk of readmission, and a higher incidence of postoperative complications.
Read the detailed description
In major abdominal surgeries, the gold standard for postoperative analgesia is thoracic epidural analgesia. Nevertheless, there are many concerns regarding its side effects, including motor blockade and hypotension. Moreover, many researchers interrogated its role as it may increase the risk of serious problems such as epidural hematoma and abscess. As an alternative, some surgeons proposed the transversus abdominis plane (TAP); however, a recent meta-analysis established that TAP block was of minimal effect.
The erector spinae plane block (ESPB) is a fairly original paraspinal plane block that was first designated for thoracic analgesia. Recently, some reports showed that it could offer effective and widespread somatic and visceral abdominal analgesia. Bilateral continuous ESP blockade represents a respected alternative to thoracic epidural analgesia. The local injection under the erector spinae muscle is carried out in this technique, which is estimated to spread a paravertebral of three vertebral levels cranially and four levels caudally. It was designated that the injected local anesthesia passes across the costotransverse foramina and blocks the ventral and dorsal rami of spinal nerves, causing a sensory blockade over the anterolateral thorax. The dermatomes enclosed by ESPB depend on the site of entry, the volume, and the concentration of the local anesthetic used. This RCT aimed to assess the analgesic effectiveness of US-guided bilateral erector spinae plane block in patients undergoing elective colectomy.
This randomized controlled trial was designed to assess the analgesic effectiveness of bilateral US-guided erector spinae plane blocks (ESPB) in patients undergoing elective colectomy surgery.
- Conditions
- Colo-rectal Cancer
- Being tested
- Bubpivacaine, Normal Saline (Placebo)
- Keywords
- erector spinae plane, colectomy
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BubpivacaineDrug
ESPB using local anesthetic 20 ml 0.25% bupivacaine on each side
Normal Saline (Placebo)Drug
ESPB using normal saline 20 ml 0.25% bupivacaine on each side
| Study group | Role | What they receive |
|---|---|---|
| ESPB | Active comparator | ESPB using local anaesthetic 20 ml 0.25% bupivacaine on each side Receives: Drug: Bubpivacaine |
| Saline | Placebo comparator | ESPB using normal saline 20 ml on each side Receives: Drug: Normal Saline (Placebo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
morphine consumption
postoperative total morphine consumption over 24 hours
Measured: From the time of end of surgery till the pass of the first 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2025
- Study start1 Aug 2021
- Primary completion30 Nov 2024
- Study completion15 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colo-rectal CancerStudies of the same condition, open and under way.
- More trials run by Suez Canal 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, Care provider
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Suez Canal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdelrhman Alshawadfy, Suez Canal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06957574
- Sponsor's protocol ID
- ESPB
- Status last verified
- Apr 2025
- First submitted
- 26 Apr 2025
- Last updated
- 13 May 2025
- Results posted
- No
- Data monitoring committee
- 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 13 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Erector Spinae Plane Block as Analgesia in Patients for Colectomy: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06957574
- Acronym / sponsor ID
- ESPB
- Conditions
- Colo-rectal Cancer
- Keywords
- erector spinae plane, colectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Suez Canal UniversityUniversity, hospital or other
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 30 Nov 2024 (actual)
- Study completion
- 15 Dec 2024 (actual)
- First posted
- 4 May 2025 (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.
Management of postoperative pain relief is largely inadequate. Despite the recent advances in pain management, postoperative pain incidence has not decreased; most patients still experience severe pain after major surgery. Poorly or inadequately controlled pain was reported to be linked to prolonged hospitalization, decreased patient satisfaction, the risk of readmission, and a higher incidence of postoperative complications.
Detailed description
In major abdominal surgeries, the gold standard for postoperative analgesia is thoracic epidural analgesia. Nevertheless, there are many concerns regarding its side effects, including motor blockade and hypotension. Moreover, many researchers interrogated its role as it may increase the risk of serious problems such as epidural hematoma and abscess. As an alternative, some surgeons proposed the transversus abdominis plane (TAP); however, a recent meta-analysis established that TAP block was of minimal effect.
The erector spinae plane block (ESPB) is a fairly original paraspinal plane block that was first designated for thoracic analgesia. Recently, some reports showed that it could offer effective and widespread somatic and visceral abdominal analgesia. Bilateral continuous ESP blockade represents a respected alternative to thoracic epidural analgesia. The local injection under the erector spinae muscle is carried out in this technique, which is estimated to spread a paravertebral of three vertebral levels cranially and four levels caudally. It was designated that the injected local anesthesia passes across the costotransverse foramina and blocks the ventral and dorsal rami of spinal nerves, causing a sensory blockade over the anterolateral thorax. The dermatomes enclosed by ESPB depend on the site of entry, the volume, and the concentration of the local anesthetic used. This RCT aimed to assess the analgesic effectiveness of US-guided bilateral erector spinae plane block in patients undergoing elective colectomy.
This randomized controlled trial was designed to assess the analgesic effectiveness of bilateral US-guided erector spinae plane blocks (ESPB) in patients undergoing elective colectomy surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ESPB | Active comparator | Drug: BubpivacaineESPB using local anaesthetic 20 ml 0.25% bupivacaine on each side |
| Saline | Placebo comparator | Drug: Normal Saline (Placebo)ESPB using normal saline 20 ml on each side |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients of colorectal carcinoma scheduled for elective colectomy
Key exclusion criteria (5 listed)
- Patients with a body mass index (BMI) of 35 kg/m2 or above
- patients with a history of hepatic or renal diseases
- patients with second- or third-degree heart blocks
- patients with coagulopathies
- patients with history of hypersensitivity to local anesthetics
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 |
|---|---|---|
| BubpivacaineESPB using local anesthetic 20 ml 0.25% bupivacaine on each side | Drug | ESPB |
| Normal Saline (Placebo)ESPB using normal saline 20 ml 0.25% bupivacaine on each side | Drug | Saline |
Primary outcome
morphine consumption
Time frame: From the time of end of surgery till the pass of the first 24 hours postoperatively
postoperative total morphine consumption over 24 hours
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 13 May 2025.
- Individual participant dataSharing planned: No
Related trials for Colo-rectal Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 2
Tislelizumab in People With Colorectal Cancer
Colorectal Cancer
Not yet recruitingPhase 2
Alberta Cancer Exercise Dose in Colorectal Cancer
Cancer, Colorectal Cancer
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bubpivacaine in people with Colo-rectal Cancer, run by Suez Canal 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 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 13 May 2025. 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?
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?
morphine consumption (time frame: From the time of end of surgery till the pass of the first 24 hours postoperatively). 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 13 May 2025.