Success Rate Under Segmental EpiduralPhase 4AnesthesiaPCNLNCT02878512
Segmental Epidural Anesthesia (SEA) V/S General Anesthesia for PCNL
A Phase 4 study testing PCNL under General Anesthesia and Segmental Epidural Anesthesia in people with Success Rate Under Segmental Epidural and Post Operative Pain, run by Maharashtra University of Health Sciences.
Trial summary
Management of nephrolithiasis has been revolutionized by the advent of shock-wave lithotripsy (ESWL) and percutaneous nephrolithotomy (PCNL). PCNL is a minimally invasive endoscopic technique and is used for the fragmentation and removal of stones of size more than 20 to 30 mm, staghorn stones or multiple stones… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Success Rate Under Segmental Epidural, Post Operative Pain
- What is being tested?
- PCNL under General Anesthesia and Segmental Epidural Anesthesia
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Jun 2009to Dec 2010
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- ASA I/II
- Age - 18 years to 60 years
- Either sex
- BMI < 30
Who cannot join
- Unwilling for consent
- ASA 3
- Obesity with BMI > 30.
- Contraindications for Epidural Anaesthesia
- Undilated pelvicalyceal system
About this study
Official title: Comparative Evaluation of General Anesthesia (SEA) Using 0.5% Bupivacaine and Segmental Epidural Anesthesia (GA) for Percutaneous Nephro Lithotomy - A Retrospective Analysis
Management of nephrolithiasis has been revolutionized by the advent of shock-wave lithotripsy (ESWL) and percutaneous nephrolithotomy (PCNL). PCNL is a minimally invasive endoscopic technique and is used for the fragmentation and removal of stones of size more than 20 to 30 mm, staghorn stones or multiple stones resistant to ESWL. Anaesthesia for PCNL is a challenge because of the disease, surgical procedure, positioning, hypothermia,and the possibility of fluid absorption, dilutional anaemia and blood loss. General anaesthesia is the gold standard for this surgery.The advent of new drugs has refined the technique of general anaesthesia. However there are several issues related to prone position still to be addressed like accidental extubation and difficult reintubation, nerve injuries and post operative respiratory complications.
Combined spinal epidural(CSE) and only epidural anaesthesia (EA) is a well established technique of anaesthesia for upper abdomen and lower thoracic surgeries. It use has also been reported in PCNL surgeries.Segmental epidural can selectively blocks pain fibres from the surgical site. This not only allows to limit the dose of the local anaesthetics, but also limit motor and sympathetic blockade. Selective sympathetic block is associated with respiratory, cardiac, gastrointestinal and metabolic benefits. This formed the basis of our current study. In the present study the investigators aimed to evaluate the efficacy of segmental epidural for PCNL and compared it with standard technique i.e. GA.
Read the detailed description
To evaluate efficacy the investigators compared intraoperative haemodynamics, surgical clearance of stones, post operative pain, surgeon's and Patient's satisfaction scores and postoperative complications and side effects in 60 ASA I and II patients undergoing PCNL surgery who received either General anesthesia or Segmental epidural Anesthesia.
- Being tested
- PCNL under General Anesthesia, Segmental Epidural Anesthesia
- Keywords
- Segmental Epidural, Regional Anesthesia for PCNL
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PCNL under General AnesthesiaProcedure or surgery
Patients undergoing percutaneous Nephrolithotomy received General anesthesia.
Segmental Epidural AnesthesiaProcedure or surgery
Also called Regional Anesthesia
Patients undergoing PCNL surgery received Segmental epidural anesthesia with 0.5% bupivacaine.
| Study group | Role | What they receive |
|---|---|---|
| PCNL under General Anesthesia | Active comparator | Patients were premedicated with Inj. Atropine 0.06 mg intramuscularly half an hour prior to surgery, IV ranitidine 1mg kg-1, IV ondansetron 0.08mg kg-1 IV midazolam 0.02mg kg-1 and Pentazocine 0.3 mg/kg. Anaesthesia was induced with IV Thiopentone sodium 3-5 mg kg-1 and Vecuronium 0.1mg kg-1.and then intubated. Anaesthesia was maintained on 50 %:50% nitrous oxide and oxygen, vecuronium and propofol infusion . At the end of the surgery postoperative analgesia was given with IV tarmadol and local nfiltration with 0.25% bupivacaine at the surgical site. Patients were reversed with IV glycopyrrolate 0.008mg kg-1 and IV neostigmine 0.06mg kg-1 and extubated. Receives: Procedure: PCNL under General Anesthesia |
| PCNL under Segmental epidural Anesthesia | Experimental | epidural space was located at T12 -L1 or L1-L2 space .The epidural catheter was inserted cephalad 5 cm upwards in the epidural space (tip approximately at T8 to T9). and test dose of 3 ml of 2% Adrenalized Lignocaine was administered..loading dose of 0.5% Bupivacaine, approximately 8 to 10 ml was injected epidurally with regular negative aspiration to block T6- T12 segments, if desired level was not achieved then additional dose of 1 to 1.5 ml 0.5% bupivacaine per spared segment was given to achieve the desired level.Motor blockade of the lower limbs was checked and noted before lithotomy, before prone and at the end of the surgery using Bromage scale. After two segment regression of sensory level epidural top up with 1/4th of initial dose 2 to 3 ml of 0.5% Bupivacaine was given. At the end of the surgery 8ml of 0.125% Bupivacaine was administered for postoperative analgesia and the catheter was removed. Receives: Procedure: Segmental Epidural Anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemodynamic parameters: Change in heart rate per minute from baseline
Change in heart rate per minute from baseline
Measured: Every 15 minutes for 2 hours and then every hourly till 24 hours
Postoperative Pain using VAS
Post operative pain was studied using VAS
Measured: Postoperatively every hourly for 24 hours
Hemodynamic parameters; change in Mean arterial pressures in mm Hg from baseline
change in mean arterial pressure from baseline
Measured: Hemodynamic parameters Change in Mean Arterial Pressure in mm Hg Every 15 minutes for 2 hours and then every hourly till 24 hours
Secondary outcomes (1)
Surgeon satisfaction score
(0-extremely poor, 1-poor, 2-fair, 3-good, 4-excellent).
Measured: 10 minutes Postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2016 (estimated)
- Study startJun 2009
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Success Rate Under Segmental EpiduralStudies 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
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maharashtra University of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shakuntala Basantwani, Maharashtra University of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02878512
- Sponsor's protocol ID
- IEC/69/16
- Acronym
- AnesthesiaPCNL
- Status last verified
- Aug 2016
- First submitted
- 23 Jun 2016
- Last updated
- 25 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Evaluation of General Anesthesia (SEA) Using 0.5% Bupivacaine and Segmental Epidural Anesthesia (GA) for Percutaneous Nephro Lithotomy - A Retrospective Analysis
- ClinicalTrials.gov ID
- NCT02878512
- Acronym / sponsor ID
- AnesthesiaPCNL / IEC/69/16
- Keywords
- Segmental Epidural, Regional Anesthesia for PCNL
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Maharashtra University of Health SciencesUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 25 Aug 2016 (estimated)
- 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 nephrolithiasis has been revolutionized by the advent of shock-wave lithotripsy (ESWL) and percutaneous nephrolithotomy (PCNL). PCNL is a minimally invasive endoscopic technique and is used for the fragmentation and removal of stones of size more than 20 to 30 mm, staghorn stones or multiple stones resistant to ESWL. Anaesthesia for PCNL is a challenge because of the disease, surgical procedure, positioning, hypothermia,and the possibility of fluid absorption, dilutional anaemia and blood loss. General anaesthesia is the gold standard for this surgery.The advent of new drugs has refined the technique of general anaesthesia. However there are several issues related to prone position still to be addressed like accidental extubation and difficult reintubation, nerve injuries and post operative respiratory complications.
Combined spinal epidural(CSE) and only epidural anaesthesia (EA) is a well established technique of anaesthesia for upper abdomen and lower thoracic surgeries. It use has also been reported in PCNL surgeries.Segmental epidural can selectively blocks pain fibres from the surgical site. This not only allows to limit the dose of the local anaesthetics, but also limit motor and sympathetic blockade. Selective sympathetic block is associated with respiratory, cardiac, gastrointestinal and metabolic benefits. This formed the basis of our current study. In the present study the investigators aimed to evaluate the efficacy of segmental epidural for PCNL and compared it with standard technique i.e. GA.
Detailed description
To evaluate efficacy the investigators compared intraoperative haemodynamics, surgical clearance of stones, post operative pain, surgeon's and Patient's satisfaction scores and postoperative complications and side effects in 60 ASA I and II patients undergoing PCNL surgery who received either General anesthesia or Segmental epidural Anesthesia.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PCNL under General Anesthesia | Active comparator | Procedure: PCNL under General AnesthesiaPatients were premedicated with Inj. Atropine 0.06 mg intramuscularly half an hour prior to surgery, IV ranitidine 1mg kg-1, IV ondansetron 0.08mg kg-1 IV midazolam 0.02mg kg-1 and Pentazocine 0.3 mg/kg. Anaesthesia was induced with IV Thiopentone sodium 3-5 mg kg-1 and Vecuronium 0.1mg kg-1.and then intubated. Anaesthesia was maintained on 50 %:50% nitrous oxide and oxygen, vecuronium and propofol infusion . At the end of the surgery postoperative analgesia was given with IV tarmadol and local nfiltration with 0.25% bupivacaine at the surgical site. Patients were reversed with IV glycopyrrolate 0.008mg kg-1 and IV neostigmine 0.06mg kg-1 and extubated. |
| PCNL under Segmental epidural Anesthesia | Experimental | Procedure: Segmental Epidural Anesthesiaepidural space was located at T12 -L1 or L1-L2 space .The epidural catheter was inserted cephalad 5 cm upwards in the epidural space (tip approximately at T8 to T9). and test dose of 3 ml of 2% Adrenalized Lignocaine was administered..loading dose of 0.5% Bupivacaine, approximately 8 to 10 ml was injected epidurally with regular negative aspiration to block T6- T12 segments, if desired level was not achieved then additional dose of 1 to 1.5 ml 0.5% bupivacaine per spared segment was given to achieve the desired level.Motor blockade of the lower limbs was checked and noted before lithotomy, before prone and at the end of the surgery using Bromage scale. After two segment regression of sensory level epidural top up with 1/4th of initial dose 2 to 3 ml of 0.5% Bupivacaine was given. At the end of the surgery 8ml of 0.125% Bupivacaine was administered for postoperative analgesia and the catheter was removed. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- ASA I/II
- Age - 18 years to 60 years
- Either sex
- BMI < 30
Key exclusion criteria (5 listed)
- Unwilling for consent
- ASA 3
- Obesity with BMI > 30.
- Contraindications for Epidural Anaesthesia
- Undilated pelvicalyceal system
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 |
|---|---|---|
| PCNL under General AnesthesiaPatients undergoing percutaneous Nephrolithotomy received General anesthesia. | Procedure or surgery | PCNL under General Anesthesia |
| Segmental Epidural AnesthesiaAlso: Regional AnesthesiaPatients undergoing PCNL surgery received Segmental epidural anesthesia with 0.5% bupivacaine. | Procedure or surgery | PCNL under Segmental epidural Anesthesia |
Primary outcome
Hemodynamic parameters: Change in heart rate per minute from baseline
Time frame: Every 15 minutes for 2 hours and then every hourly till 24 hours
Change in heart rate per minute from baseline
Postoperative Pain using VAS
Time frame: Postoperatively every hourly for 24 hours
Post operative pain was studied using VAS
Hemodynamic parameters; change in Mean arterial pressures in mm Hg from baseline
Time frame: Hemodynamic parameters Change in Mean Arterial Pressure in mm Hg Every 15 minutes for 2 hours and then every hourly till 24 hours
change in mean arterial pressure from baseline
1 secondary outcome
Surgeon satisfaction score
Time frame: 10 minutes Postoperative
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 25 Aug 2016.
- Individual participant dataSharing planned: No
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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing PCNL under General Anesthesia and Segmental Epidural Anesthesia in people with Success Rate Under Segmental Epidural and Post Operative Pain, run by Maharashtra University of Health Sciences.
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 4 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 25 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Hemodynamic parameters: Change in heart rate per minute from baseline (time frame: Every 15 minutes for 2 hours and then every hourly till 24 hours). The study lists 3 primary outcomes in all. 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 25 Aug 2016.