Gastric Cancer, Hepatobiliary Cancer, Pancreatic Cancer, Upper Abdominal Cancer Pain
Conditions
Keywords
Cancer Pain, Upper Abdominal Cancer Pain, Splanchnic Nerve Neurolysis, Transdiscal Splanchnic Nerve Neurolysis, Opioid-Sparing Analgesia
Brief summary
The goal of this prospective study is to learn whether fluoroscopy-guided transdiscal splanchnic nerve neurolysis can safely reduce severe upper abdominal cancer pain in adults with pancreatic, gastric, or hepatobiliary cancer. The study will also assess whether this procedure can reduce the need for opioid pain medicines and improve patients' functional status and quality of life. The main questions it aims to answer are: Does the procedure reduce patients' pain one month after treatment? Does it reduce the amount of opioid pain medication patients need? Does it improve functional status and quality of life? What complications or side effects occur after the procedure? How long does pain relief last, and how often is repeat treatment needed? Participants will: First receive a diagnostic splanchnic nerve block with local anesthetic. If the diagnostic block provides at least 50% pain relief, undergo transdiscal splanchnic nerve neurolysis using fluoroscopy guidance. Receive a neurolytic agent (absolute alcohol or phenol) through a needle placed at the T11-T12 or T12-L1 level. Have their pain, opioid medication use, functional status, complications, and satisfaction assessed before treatment and during follow-up. Complete follow-up assessments at 1 week, 1 month, 3 months, and 6 months after the procedure. Complete a quality-of-life questionnaire before treatment and at 1 month. The primary outcome will be the change in pain score on the 0-10 Numeric Rating Scale at 1 month after the procedure.
Interventions
PROCEDUREChemical Neurolysis
Chemical neurolysis will be performed using the study-specified neurolytic agent (alcohol or phenol) to provide pain relief in patients with chronic pain. The procedure will be performed under appropriate clinical and imaging guidance according to the study protocol. Participants will be followed prospectively to assess pain relief, duration of analgesia, functional outcomes, and procedure-related adverse events
Sponsors
Sahiwal medical college sahiwal
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 years. Confirmed diagnosis of pancreatic, gastric, or hepatobiliary malignancy with epigastric/upper abdominal pain. Baseline NRS ≥ 7 despite optimized pharmacotherapy, or intolerable opioid side effects. ≥ 50% pain relief on diagnostic splanchnic nerve block. Able to provide informed consent.
Exclusion criteria
* Coagulopathy (INR \> 1.5, platelets \< 50,000/µL). Local or systemic infection. Uncontrolled hypotension or severe cardiopulmonary compromise precluding prone positioning. Intestinal obstruction. Known allergy to contrast, local anesthetic, or the neurolytic agent. Patient refusal.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in pain intensity | Baseline to 1 month after the procedure | Pain intensity will be assessed using the 0-10 Numeric Rating Scale (NRS), where 0 represents no pain and 10 represents the worst imaginable pain. The change in NRS pain score from baseline will be assessed following fluoroscopy-guided transdiscal splanchnic nerve neurolysis. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in quality of life | Baseline, 1 month, 3 months, and 6 months | Quality of life will be assessed using the EORTC QLQ-C30 questionnaire. |
| Technical success of neurolysis | During the procedure | Successful completion of fluoroscopy-guided transdiscal splanchnic nerve neurolysis as intended according to the study protocol. |
| Opioid consumption | Baseline, 1 week, 1 month, | Change in daily opioid consumption expressed as oral morphine milligram equivalents (MME) compared with baseline. |
Countries
Pakistan
Contacts
CONTACTUmer Hussain, MBBS
CONTACTMuhammad Shahid, MBBS, FCPS
Outcome results
None listed