PainNCT02803385
Comparison of Patient Controlled & Continuous Epidural Analgesia in Thoraco-abdominal Surgeries in Cancer Patients
A study testing Continous Epidural Analgesia in people with Pain, run by Tata Memorial Centre at 1 site in India.
Trial summary
This study aims to compare the efficacy of pain control, the consumption of local anesthetic and opioids, side effects, and patient satisfaction between continuous epidural infusion and patient controlled epidural analgesia after thoraco-abdominal surgeries in cancer patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain
- What is being tested?
- Continous Epidural Analgesia
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteIndia
- Study dates
- Jul 2016to Jan 2019
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All adult patients, American Society of Anaesthesia class I-II, posted for thoraco-abdominal surgeries and planned for epidural catheter insertion for perioperative pain management, will be included. The surgeries will include gastrectomy, radical \& revision cholecystectomy, whipples procedure, pancreatectomy, lobectomy, metastectomy, pneumonectomy will be included.
Who cannot join
- Patients with contraindication to epidural catheter placement or use of opioids or local anesthetic
- Patients with contraindication to use of rescue analgesia like paracetamol and diclofenac both in postoperative period
- Multiple incision not covered with epidural like TTE, THE
- Patients with failed epidural insertion
- Patients with epidural band not covering the incision sites completely
- Patient with hemodynamic instability leading to inability to use epidural within the first 4-6 hours.
- Patient shifted on ventilator or needing ventilator support the within first 6-12 hours.
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Efficacy of Patient Controlled Epidural Analgesia Versus Continuous Epidural Infusion Following Thoraco-abdominal Surgeries in Cancer Patients
This study aims to compare the efficacy of pain control, the consumption of local anesthetic and opioids, side effects, and patient satisfaction between continuous epidural infusion and patient controlled epidural analgesia after thoraco-abdominal surgeries in cancer patients.
Read the detailed description
Aim-
- To compare the pain scores during rest and movement with continuous epidural infusion (CEI) vs. patient controlled epidural analgesia (PCEA)
- To compare the incidence of side effects between 2 groups
- Comparison of local anaesthetic and opioids requirement by PCA attempts and also rescue analgesia requirement.
- To compare patient satisfaction with the two different modalities of pain management
Sample size- Based on our hospital data for postoperative pain management after thoraco-abdominal surgeries, it was found that 69.7 % patients experience moderate to severe pain (pain score 4-10) on first day postoperatively.
Considering a 50% reduction as meaningful, group sample size of 62 with 31 in each group was calculated using a chi square test. Assuming a 10% loss to follow up or drop outs from study we require 35 in each group with total sample size of 70.
Variables- age, sex, demographic factors, surgery, duration of surgery, pain score, nausea score, hypotension episode, pruritis, Vomiting episode, patients satisfaction score, requirement of rescue analgesia.
Analysis of variables:
Descriptive statistics will be used for data representation. The χ2 and Fisher's exact probability tests will be used to analyze the differences between qualitative data. Comparisons of two groups will be analyzed using the Independent sample t test or Mann-Whitney U test as per the distribution of data. A P-value less than 0.05 will be considered statistically significant. Patient satisfaction using verbal rating scale will be analysed using Mann-Whitney U test.
Methodology- Patient meeting inclusion criteria, 4 hours after surgery will be reassessed in absence of any post-operative exclusion criteria, patient will be randomized into either group as per a computer generated chart and study will start from this time.
Postoperative group A will receive continuous epidural infusion at rate of 5-8 ml /hr based on maximum allowable safe dose as per body weight[10]. The Patient Controlled Analgesia settings will be set at 0.1 ml per bolus with lockout interval of 20 minutes.
Group B will receive patient controlled epidural analgesia in form of Patient Controlled analgesia pumps with continuous rate of 5-8ml/hour \& demand dose of 2-3 ml p.r.n with a lock out interval of 20 minutes based on maximum allowable safe dose as per body weight . Both the groups will have a cross over at 36 hours postop.
- Conditions
- Pain
- Being tested
- Continous Epidural Analgesia, Patient Controlled Epidural Analgesia
- Keywords
- Patient Controlled Epidural Analgesia, Continous Epidural Infusion Analgesia
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continous Epidural AnalgesiaOther
Also called continous epidural infusion of local anesthetic with opioid
continuous epidural infusion at rate of 5-8 ml /hr based on maximum allowable safe dose as per body weight. The pump settings will be set at 0.1 ml per bolus with lockout interval of 20 minutes. Cross over to other group will occur after 36hours.
Patient Controlled Epidural AnalgesiaOther
Also called patient controlled boluses of local anesthetic with opioid
patient controlled epidural analgesia in form of Patient Controlled Analgesia pumps with continuous rate of 5-8ml/hour \& demand dose of 2-3 ml p.r.n with a lock out interval of 20 minutes based on maximum allowable safe dose as per body weight .The group will have a cross over at 36 hours postop.
| Study group | Role | What they receive |
|---|---|---|
| Continous Epidural Analgesia | Active comparator | Continuous epidural infusion at rate of 5-8 ml /hr based on maximum allowable safe dose as per body weight. The Patient Controlled Analgesia pump settings will be set at 0.1 ml per bolus with lockout interval of 20 minutes Receives: Other: Continous Epidural Analgesia |
| Patient Controlled Epidural Analgesia | Active comparator | Patient controlled epidural analgesia in form of PCA pumps with continuous rate of 5-8ml/hour \& demand dose of 2-3 ml p.r.n with a lock out interval of 20 minutes based on maximum allowable safe dose as per body weight . Receives: Other: Patient Controlled Epidural Analgesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the pain scores during rest and movement with continuous epidural infusion (CEI) vs. patient controlled epidural analgesia (PCEA)
pain scores to be assessed using Numerical Rating scale(1-10)
Measured: 72 hours
Secondary outcomes (2)
To compare patient satisfaction between the two groups using Verbal Rating scale
Measured: 36 hours and 72 hours
To assess the incidence of side effects in both groups including hypotension, motor weakness, pruritus, nausea, vomiting and any other
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2016 (estimated)
- Study startJul 2016
- Primary completionDec 2018
- Study completionJan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Tata Memorial CentreThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tata Memorial Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, parmanand jain, Tata Memorial Centre
- Investigators
- Parmanand Jain, MD, MNAMS, Principal investigator, ProfessorSumitra Bakshi, MD, Study chair, ProfessorAnkita Lapalikar, MBBS, Study chair, Student
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02803385
- Sponsor's protocol ID
- 1681
- Status last verified
- Oct 2021
- First submitted
- 8 Jun 2016
- Last updated
- 6 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Liu SS, Allen HW, Olsson GL. Patient-controlled epidural analgesia with bupivacaine and fentanyl on hospital wards: prospective experience with 1,030 surgical patients. Anesthesiology. 1998 Mar;88(3):688-95. doi: 10.1097/00000542-199803000-00020.
PubMed 9523813Komatsu H, Matsumoto S, Mitsuhata H, Abe K, Toriyabe S. Comparison of patient-controlled epidural analgesia with and without background infusion after gastrectomy. Anesth Analg. 1998 Oct;87(4):907-10. doi: 10.1097/00000539-199810000-00030.
PubMed 9768792Standl T, Burmeister MA, Ohnesorge H, Wilhelm S, Striepke M, Gottschalk A, Horn EP, Schulte Am Esch J. Patient-controlled epidural analgesia reduces analgesic requirements compared to continuous epidural infusion after major abdominal surgery. Can J Anaesth. 2003 Mar;50(3):258-64. doi: 10.1007/BF03017795.
PubMed 12620949
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Efficacy of Patient Controlled Epidural Analgesia Versus Continuous Epidural Infusion Following Thoraco-abdominal Surgeries in Cancer Patients
- ClinicalTrials.gov ID
- NCT02803385
- Acronym / sponsor ID
- 1681
- Conditions
- Pain
- Keywords
- Patient Controlled Epidural Analgesia, Continous Epidural Infusion Analgesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Tata Memorial CentreUniversity, hospital or other
- Study start
- Jul 2016 (actual)
- Primary completion
- Dec 2018 (actual)
- Study completion
- Jan 2019 (actual)
- First posted
- 17 Jun 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.
This study aims to compare the efficacy of pain control, the consumption of local anesthetic and opioids, side effects, and patient satisfaction between continuous epidural infusion and patient controlled epidural analgesia after thoraco-abdominal surgeries in cancer patients.
Detailed description
Aim-
- To compare the pain scores during rest and movement with continuous epidural infusion (CEI) vs. patient controlled epidural analgesia (PCEA)
- To compare the incidence of side effects between 2 groups
- Comparison of local anaesthetic and opioids requirement by PCA attempts and also rescue analgesia requirement.
- To compare patient satisfaction with the two different modalities of pain management
Sample size- Based on our hospital data for postoperative pain management after thoraco-abdominal surgeries, it was found that 69.7 % patients experience moderate to severe pain (pain score 4-10) on first day postoperatively.
Considering a 50% reduction as meaningful, group sample size of 62 with 31 in each group was calculated using a chi square test. Assuming a 10% loss to follow up or drop outs from study we require 35 in each group with total sample size of 70.
Variables- age, sex, demographic factors, surgery, duration of surgery, pain score, nausea score, hypotension episode, pruritis, Vomiting episode, patients satisfaction score, requirement of rescue analgesia.
Analysis of variables:
Descriptive statistics will be used for data representation. The χ2 and Fisher's exact probability tests will be used to analyze the differences between qualitative data. Comparisons of two groups will be analyzed using the Independent sample t test or Mann-Whitney U test as per the distribution of data. A P-value less than 0.05 will be considered statistically significant. Patient satisfaction using verbal rating scale will be analysed using Mann-Whitney U test.
Methodology- Patient meeting inclusion criteria, 4 hours after surgery will be reassessed in absence of any post-operative exclusion criteria, patient will be randomized into either group as per a computer generated chart and study will start from this time.
Postoperative group A will receive continuous epidural infusion at rate of 5-8 ml /hr based on maximum allowable safe dose as per body weight[10]. The Patient Controlled Analgesia settings will be set at 0.1 ml per bolus with lockout interval of 20 minutes.
Group B will receive patient controlled epidural analgesia in form of Patient Controlled analgesia pumps with continuous rate of 5-8ml/hour \& demand dose of 2-3 ml p.r.n with a lock out interval of 20 minutes based on maximum allowable safe dose as per body weight . Both the groups will have a cross over at 36 hours postop.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Continous Epidural Analgesia | Active comparator | Other: Continous Epidural AnalgesiaContinuous epidural infusion at rate of 5-8 ml /hr based on maximum allowable safe dose as per body weight. The Patient Controlled Analgesia pump settings will be set at 0.1 ml per bolus with lockout interval of 20 minutes |
| Patient Controlled Epidural Analgesia | Active comparator | Other: Patient Controlled Epidural AnalgesiaPatient controlled epidural analgesia in form of PCA pumps with continuous rate of 5-8ml/hour \& demand dose of 2-3 ml p.r.n with a lock out interval of 20 minutes based on maximum allowable safe dose as per body weight . |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All adult patients, American Society of Anaesthesia class I-II, posted for thoraco-abdominal surgeries and planned for epidural catheter insertion for perioperative pain management, will be included. The surgeries will include gastrectomy, radical \& revision cholecystectomy, whipples procedure, pancreatectomy, lobectomy, metastectomy, pneumonectomy will be included.
Key exclusion criteria (8 listed)
- Patients with contraindication to epidural catheter placement or use of opioids or local anesthetic
- Patients with contraindication to use of rescue analgesia like paracetamol and diclofenac both in postoperative period
- Multiple incision not covered with epidural like TTE, THE
- Patients with failed epidural insertion
- Patients with epidural band not covering the incision sites completely
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 |
|---|---|---|
| Continous Epidural AnalgesiaAlso: continous epidural infusion of local anesthetic with opioidcontinuous epidural infusion at rate of 5-8 ml /hr based on maximum allowable safe dose as per body weight. The pump settings will be set at 0.1 ml per bolus with lockout interval of 20 minutes. Cross over to other group will occur after 36hours. | Other | Continous Epidural Analgesia |
| Patient Controlled Epidural AnalgesiaAlso: patient controlled boluses of local anesthetic with opioidpatient controlled epidural analgesia in form of Patient Controlled Analgesia pumps with continuous rate of 5-8ml/hour \& demand dose of 2-3 ml p.r.n with a lock out interval of 20 minutes based on maximum allowable safe dose as per body weight .The group will have a cross over at 36 hours postop. | Other | Patient Controlled Epidural Analgesia |
Primary outcome
To compare the pain scores during rest and movement with continuous epidural infusion (CEI) vs. patient controlled epidural analgesia (PCEA)
Time frame: 72 hours
pain scores to be assessed using Numerical Rating scale(1-10)
2 secondary outcomes
To compare patient satisfaction between the two groups using Verbal Rating scale
Time frame: 36 hours and 72 hours
To assess the incidence of side effects in both groups including hypotension, motor weakness, pruritus, nausea, vomiting and any other
Time frame: 72 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 6 Oct 2021.
- Results publication: PubMed 9523813Liu SS, Allen HW, Olsson GL. Patient-controlled epidural analgesia with bupivacaine and fentanyl on hospital wards: prospective experience with 1,030 surgical patients. Anesthesiology. 1998 Mar;88(3):688-95. doi: 10.1097/00000542-199803000-00020.
- Results publication: PubMed 9768792Komatsu H, Matsumoto S, Mitsuhata H, Abe K, Toriyabe S. Comparison of patient-controlled epidural analgesia with and without background infusion after gastrectomy. Anesth Analg. 1998 Oct;87(4):907-10. doi: 10.1097/00000539-199810000-00030.
- Results publication: PubMed 12620949Standl T, Burmeister MA, Ohnesorge H, Wilhelm S, Striepke M, Gottschalk A, Horn EP, Schulte Am Esch J. Patient-controlled epidural analgesia reduces analgesic requirements compared to continuous epidural infusion after major abdominal surgery. Can J Anaesth. 2003 Mar;50(3):258-64. doi: 10.1007/BF03017795.
- Individual participant dataSharing planned: No
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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.
Parmanand Jain, MD, MNAMS principal investigator
Professor
Sumitra Bakshi, MD study chair
Professor
Ankita Lapalikar, MBBS study chair
Student
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continous Epidural Analgesia in people with Pain, run by Tata Memorial Centre at 1 site in India.
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 8 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 6 Oct 2021. 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 India. 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?
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?
To compare the pain scores during rest and movement with continuous epidural infusion (CEI) vs. patient controlled epidural analgesia (PCEA) (time frame: 72 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 NCT02803385, which also lists 3 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 6 Oct 2021.