Abdominal CancerPhase 4NCT06316908
Permanent Celiac Plexus Block: Comparison of Pain Score in Unilateral and Bilateral Posterior Percutaneous Approach
A Phase 4 study testing Unilateral Neurolytic Celiac Plexus Block with Absolute Alcohol and Bilateral Neurolytic Celiac Plexus Block with Absolute Alcohol in people with Abdominal Cancer and Cancer Pain, run by Sindh Institute of Urology and Transplantation at 1 site in Pakistan.
Trial summary
The goal of this prospective, interventional, non-randomized study was to compare pain score in unilateral and bilateral posterior percutaneous neurolytic celiac plexus block (NCPB) in upper abdominal cancer patients. The main questions it aimed to answer are: 1. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Abdominal Cancer, Cancer Pain, Cancer of Pancreas
- What is being tested?
- Unilateral Neurolytic Celiac Plexus Block with Absolute Alcohol and Bilateral Neurolytic Celiac Plexus Block with Absolute Alcohol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 sitePakistan
- Study dates
- 25 Feb 2020to 15 Mar 2023
- Phase
- Phase 4
- 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
- All upper abdominal malignancy adult patients
- on palliative care,
- having a visual analog scale (VAS) of more than 7
Who cannot join
- Patients on anti-coagulant medications,
- having an INR > 1.50 and or
- Platelets count < 80000,
- inability to provide informed consent, or
- those who have previously undergone celiac plexus intervention.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Sindh Institute of Urology and Transplantation
Karachi, Sindh, 74200
About this study
The goal of this prospective, interventional, non-randomized study was to compare pain score in unilateral and bilateral posterior percutaneous neurolytic celiac plexus block (NCPB) in upper abdominal cancer patients.
The main questions it aimed to answer are:
- Whether unilateral or bilateral NCPB technique has a better pain relief
- Was there any difference in terms of complication rates between these two approaches All participants were having upper abdominal cancer whether operated or non-operable cancer were given a unilateral or bilateral neurolytic celiac plexus block.
Pain scores and adverse events at multiple time points post-procedure were recorded.
Read the detailed description
After Institutional Research Committee clearance and Ethical Review Committee approval from the Sindh Institute of Urology \& Transplantation, the patients were divided into two groups, 15 patients in each group. Forty milliliters of the study drug were prepared in a 50 milliliters (mL) syringe by a pharmacy person. Patients were nil per oral (NPO) for six hours and after a written informed consent, patients were brought in the operating room. A 20-gauge (G) intravenous (I/V) cannula was passed and started injection ringer lactate at 10 mL/kg body weight, for all patients except diabetic mellitus who received normal saline. Monitors were applied as per American Society of Anesthesiologist (ASA) standards i.e., electrocardiogram (ECG), oxygen saturation (SpO2), and non-invasive blood pressure (NIBP), and vitals were recorded at intervals of 5 minutes (min). Patients were then positioned prone on the operation table and their arms were rested on the arm board. Pillows were placed under the abdomen between the ribs and iliac crest.
First, a mark was made between the 12 Thoracic (T12) and 1st Lumbar (L1) vertebra under the Fluoroscopic C arm view. Then a line was drawn between the points at 5 and 7 cm lateral from the spinous process of the L3 vertebra. Injection 2% plain xylocaine 3-5 milliliters (mL) was locally infiltrated and a 20-centimeter (cm) 22gauge (G) Chiba needle was inserted at an angle of 45 degrees with the skin and directed medially and in cephalic direction. After making contact with the body of the L1 vertebra needle was withdrawn and reinserted with an increased angle between the needle shaft and the skin until the tip of the needle slipped off the body of the L1 vertebra. Then the needle was advanced 1-1.5 cm in front of the T12 \& L1 vertebrae. The position of the needle was confirmed in the anterior and lateral views of the vertebra with the help of radiopaque dye under a fluoroscopic C arm view. After the proper confirmation of the tip of the needle, 40 mL of absolute alcohol was injected into the unilateral block. Whereas, in the bilateral technique 20 mL absolute alcohol on both sides were injected. During and after the drug administration the pattern of the drug distribution was observed very carefully anterior to the body of the L1 vertebra and psoas fascia, and any visceral and I/V drug administration was avoided. After alcohol administration, 0.25 % Bupivacaine 5 mL was given, and then withdrawn the needle. The patient remained in the prone position for 20 mins. After the patients were turned supine and shifted to the post-anesthesia care unit (PACU) for monitoring of vitals for 30 mins after which they shifted to the ward. Pain score was recorded immediately and then at 30 mins in PACU, then at 6, 12, and 24 hours. Patients were discharged after 24 hours or when stable, pain score was recorded on telephonic conversation/ outpatient clinic visits at 7 days, 1 month, 3 months, and 6 months after the procedure or till death if the patient expired before 6 months.
- Conditions
- Abdominal Cancer, Cancer Pain, Cancer of Pancreas
- Being tested
- Unilateral Neurolytic Celiac Plexus Block with Absolute Alcohol, Bilateral Neurolytic Celiac Plexus Block with Absolute Alcohol
- Medical subject headings
- Cancer Pain, Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Unilateral Neurolytic Celiac Plexus Block with Absolute AlcoholDrug
Participants assigned to the unilateral neurolytic celiac plexus block group underwent a minimally invasive procedure where a solution of absolute alcohol was injected unilaterally into the celiac plexus under image guidance. The procedure was performed by an experienced interventional pain specialist. Prior to the injection, local anesthesia was administered to minimize discomfort. Once positioned correctly, a needle was inserted into the designated area, and a small amount of absolute alcohol was injected to disrupt the neural pathways responsible for transmitting pain signals from the abdominal region. The intervention aims to provide long-term pain relief for participants suffering from chronic abdominal pain.
Bilateral Neurolytic Celiac Plexus Block with Absolute AlcoholDrug
Participants allocated to the bilateral neurolytic celiac plexus block group underwent a similar minimally invasive procedure as described above, with the exception that the injection of absolute alcohol was administered bilaterally into the celiac plexus. The procedure was performed by an experienced interventional pain specialist under image guidance, with local anesthesia administered prior to the injection to ensure patient comfort. Following correct needle placement, absolute alcohol was injected into both sides of the celiac plexus to disrupt neural pathways responsible for transmitting pain signals from the abdominal region. The intervention aims to provide comparable or potentially enhanced long-term pain relief compared to the unilateral approach, with the additional benefit of targeting both sides of the celiac plexus.
| Study group | Role | What they receive |
|---|---|---|
| Unilateral Approach Group | Active comparator | Patients in this group have received a unilateral percutaneous posterior approach for NCPB. The procedure was performed under fluoroscopic guidance Receives: Drug: Unilateral Neurolytic Celiac Plexus Block with Absolute Alcohol |
| Bilateral Approach Group | Active comparator | Patients in this group have undergone a bilateral percutaneous posterior approach for NCPB, following the same procedural guidance. Receives: Drug: Bilateral Neurolytic Celiac Plexus Block with Absolute Alcohol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Score using the Visual Analog Scale
The visual analog scale consists of a 10 cm long horizontal line, with a minimum value of 0 (no pain) and a maximum value of 10 (worst pain imaginable). Higher scores indicate a worse outcome.
Measured: 6 months post-procedure
Secondary outcomes (3)
Change in Mean Arterial Pressure
Change in mean arterial pressure from baseline (pre-procedure) to 4 hours post-procedure. Mean arterial pressure was measured by a non-invasive automated blood pressure reader.
Measured: 4 hours post-procedure
Incidence of Patient-Reported Nausea Feeling
Nausea was defined as patient reported feeling of urge to vomit. The incidence will be reported as the percentage of patients who report experiencing nausea at least once during the follow-up period.
Measured: 24 hours post-procedure
Incidence of Vomiting
The occurrence and frequency of vomiting was documented through patient self-reporting or clinical observation.
Measured: 24 hours post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2024
- Study start25 Feb 2020
- Primary completion15 Jul 2022
- Study completion15 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal CancerStudies 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 4
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Unilateral Approach Group: Patients in this group have received a unilateral percutaneous posterior approach for NCPB. The procedure was performed under fluoroscopic guidance. Bilateral Approach Group: Patients in this group have undergone a bilateral percutaneous posterior approach for NCPB, following the same procedural guidance.
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sindh Institute of Urology and Transplantation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Syed Muhammad Abbas, Sindh Institute of Urology and Transplantation
- Investigators
- Muhammad Q Abbas, MCPS, FCPS, Principal investigator, Professor Dept of Anaesthesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06316908
- Sponsor's protocol ID
- ERC-2019/A187
- Status last verified
- Mar 2024
- First submitted
- 21 Jan 2024
- Last updated
- 19 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Permanent Celiac Plexus Block: Comparison of Pain Score in Unilateral and Bilateral Posterior Percutaneous Approach
- ClinicalTrials.gov ID
- NCT06316908
- Acronym / sponsor ID
- ERC-2019/A187
- Conditions
- Abdominal Cancer, Cancer Pain, Cancer of Pancreas
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Sindh Institute of Urology and TransplantationUniversity, hospital or other
- Study start
- 25 Feb 2020 (actual)
- Primary completion
- 15 Jul 2022 (actual)
- Study completion
- 15 Mar 2023 (actual)
- First posted
- 19 Mar 2024 (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 goal of this prospective, interventional, non-randomized study was to compare pain score in unilateral and bilateral posterior percutaneous neurolytic celiac plexus block (NCPB) in upper abdominal cancer patients.
The main questions it aimed to answer are:
- Whether unilateral or bilateral NCPB technique has a better pain relief
- Was there any difference in terms of complication rates between these two approaches All participants were having upper abdominal cancer whether operated or non-operable cancer were given a unilateral or bilateral neurolytic celiac plexus block.
Pain scores and adverse events at multiple time points post-procedure were recorded.
Detailed description
After Institutional Research Committee clearance and Ethical Review Committee approval from the Sindh Institute of Urology \& Transplantation, the patients were divided into two groups, 15 patients in each group. Forty milliliters of the study drug were prepared in a 50 milliliters (mL) syringe by a pharmacy person. Patients were nil per oral (NPO) for six hours and after a written informed consent, patients were brought in the operating room. A 20-gauge (G) intravenous (I/V) cannula was passed and started injection ringer lactate at 10 mL/kg body weight, for all patients except diabetic mellitus who received normal saline. Monitors were applied as per American Society of Anesthesiologist (ASA) standards i.e., electrocardiogram (ECG), oxygen saturation (SpO2), and non-invasive blood pressure (NIBP), and vitals were recorded at intervals of 5 minutes (min). Patients were then positioned prone on the operation table and their arms were rested on the arm board. Pillows were placed under the abdomen between the ribs and iliac crest.
First, a mark was made between the 12 Thoracic (T12) and 1st Lumbar (L1) vertebra under the Fluoroscopic C arm view. Then a line was drawn between the points at 5 and 7 cm lateral from the spinous process of the L3 vertebra. Injection 2% plain xylocaine 3-5 milliliters (mL) was locally infiltrated and a 20-centimeter (cm) 22gauge (G) Chiba needle was inserted at an angle of 45 degrees with the skin and directed medially and in cephalic direction. After making contact with the body of the L1 vertebra needle was withdrawn and reinserted with an increased angle between the needle shaft and the skin until the tip of the needle slipped off the body of the L1 vertebra. Then the needle was advanced 1-1.5 cm in front of the T12 \& L1 vertebrae. The position of the needle was confirmed in the anterior and lateral views of the vertebra with the help of radiopaque dye under a fluoroscopic C arm view. After the proper confirmation of the tip of the needle, 40 mL of absolute alcohol was injected into the unilateral block. Whereas, in the bilateral technique 20 mL absolute alcohol on both sides were injected. During and after the drug administration the pattern of the drug distribution was observed very carefully anterior to the body of the L1 vertebra and psoas fascia, and any visceral and I/V drug administration was avoided. After alcohol administration, 0.25 % Bupivacaine 5 mL was given, and then withdrawn the needle. The patient remained in the prone position for 20 mins. After the patients were turned supine and shifted to the post-anesthesia care unit (PACU) for monitoring of vitals for 30 mins after which they shifted to the ward. Pain score was recorded immediately and then at 30 mins in PACU, then at 6, 12, and 24 hours. Patients were discharged after 24 hours or when stable, pain score was recorded on telephonic conversation/ outpatient clinic visits at 7 days, 1 month, 3 months, and 6 months after the procedure or till death if the patient expired before 6 months.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Unilateral Approach Group: Patients in this group have received a unilateral percutaneous posterior approach for NCPB. The procedure was performed under fluoroscopic guidance. Bilateral Approach Group: Patients in this group have undergone a bilateral percutaneous posterior approach for NCPB, following the same procedural guidance.
| Arm | Type | Receives |
|---|---|---|
| Unilateral Approach Group | Active comparator | Drug: Unilateral Neurolytic Celiac Plexus Block with Absolute AlcoholPatients in this group have received a unilateral percutaneous posterior approach for NCPB. The procedure was performed under fluoroscopic guidance |
| Bilateral Approach Group | Active comparator | Drug: Bilateral Neurolytic Celiac Plexus Block with Absolute AlcoholPatients in this group have undergone a bilateral percutaneous posterior approach for NCPB, following the same procedural guidance. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- All upper abdominal malignancy adult patients
- on palliative care,
- having a visual analog scale (VAS) of more than 7
Key exclusion criteria (5 listed)
- Patients on anti-coagulant medications,
- having an INR > 1.50 and or
- Platelets count < 80000,
- inability to provide informed consent, or
- those who have previously undergone celiac plexus intervention.
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 |
|---|---|---|
| Unilateral Neurolytic Celiac Plexus Block with Absolute AlcoholParticipants assigned to the unilateral neurolytic celiac plexus block group underwent a minimally invasive procedure where a solution of absolute alcohol was injected unilaterally into the celiac plexus under image guidance. The procedure was performed by an experienced interventional pain specialist. Prior to the injection, local anesthesia was administered to minimize discomfort. Once positioned correctly, a needle was inserted into the designated area, and a small amount of absolute alcohol was injected to disrupt the neural pathways responsible for transmitting pain signals from the abdominal region. The intervention aims to provide long-term pain relief for participants suffering from chronic abdominal pain. | Drug | Unilateral Approach Group |
| Bilateral Neurolytic Celiac Plexus Block with Absolute AlcoholParticipants allocated to the bilateral neurolytic celiac plexus block group underwent a similar minimally invasive procedure as described above, with the exception that the injection of absolute alcohol was administered bilaterally into the celiac plexus. The procedure was performed by an experienced interventional pain specialist under image guidance, with local anesthesia administered prior to the injection to ensure patient comfort. Following correct needle placement, absolute alcohol was injected into both sides of the celiac plexus to disrupt neural pathways responsible for transmitting pain signals from the abdominal region. The intervention aims to provide comparable or potentially enhanced long-term pain relief compared to the unilateral approach, with the additional benefit of targeting both sides of the celiac plexus. | Drug | Bilateral Approach Group |
Primary outcome
Pain Score using the Visual Analog Scale
Time frame: 6 months post-procedure
The visual analog scale consists of a 10 cm long horizontal line, with a minimum value of 0 (no pain) and a maximum value of 10 (worst pain imaginable). Higher scores indicate a worse outcome.
3 secondary outcomes
Change in Mean Arterial Pressure
Time frame: 4 hours post-procedure
Incidence of Patient-Reported Nausea Feeling
Time frame: 24 hours post-procedure
Incidence of Vomiting
Time frame: 24 hours post-procedure
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 19 Mar 2024.
- Individual participant dataSharing planned: No
Related trials for Abdominal Cancer
RecruitingPhase 2
Investigation of Ubamatamab Combination Therapy in Adult Participants With Platinum-Resistant Ovarian Cancer
Ovarian Cancer, Fallopian Tube Cancer
Not yet recruiting
Nurse-Led Prehabilitation Before Major Abdominal Cancer Surgery
Colorectal Cancer
RecruitingPhase 1
Study of Preoperative Radiation Therapy in Participants With Resectable Recurrent Abdominal Adrenocortical Carcinoma
Adrenocortical Carcinoma (ACC), Recurrent Adrenocortical Carcinoma (ACC)
RecruitingPhase 1
Individual Response to Hyperthermic Intraperitoneal Chemotherapy (HIPEC) Treatment of Peritoneal Carcinomatosis From Peritoneal Mesothelioma or Atypical Mesothelial Proliferation or From Ovarian, Colorectal, or Appendiceal Histologies
Peritoneal Mesothelioma, Peritoneal Carcinomatosis
RecruitingPhase 3
A Three-Part Phase 3 Study of Sofetabart Mipitecan in Participants With Platinum-Resistant (Part A) and Platinum-Sensitive (Parts B and C) Ovarian Cancer
Ovarian Neoplasms, Fallopian Tube Neoplasms
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.
Muhammad Q Abbas, MCPS, FCPS principal investigator
Professor Dept of Anaesthesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Unilateral Neurolytic Celiac Plexus Block with Absolute Alcohol and Bilateral Neurolytic Celiac Plexus Block with Absolute Alcohol in people with Abdominal Cancer and Cancer Pain, run by Sindh Institute of Urology and Transplantation at 1 site in Pakistan.
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 3 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 19 Mar 2024. 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 Pakistan. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Pain Score using the Visual Analog Scale (time frame: 6 months post-procedure). 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 19 Mar 2024.