Comparison of Patient Controlled & Continuous Epidural Analgesia in Thoraco-abdominal Surgeries in Cancer Patients

NCT ID: NCT02803385

Last Updated: 2021-10-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-07-31
• Study Completion Date: 2019-01-31

Brief 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.

Detailed Description

Aim-

1. To compare the pain scores during rest and movement with continuous epidural infusion (CEI) vs. patient controlled epidural analgesia (PCEA)

2. To compare the incidence of side effects between 2 groups

3. Comparison of local anaesthetic and opioids requirement by PCA attempts and also rescue analgesia requirement.

4. 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Continous Epidural Analgesia

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

Group Type: ACTIVE_COMPARATOR

Continous Epidural Analgesia

Intervention Type: OTHER

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 Analgesia

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 .

Group Type: ACTIVE_COMPARATOR

Patient Controlled Epidural Analgesia

Intervention Type: OTHER

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.

Interventions

Continous Epidural Analgesia

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.

Intervention Type: OTHER

Patient Controlled Epidural Analgesia

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.

Intervention Type: OTHER

Other Intervention Names

continous epidural infusion of local anesthetic with opioid; patient controlled boluses of local anesthetic with opioid

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

1. Patients with contraindication to epidural catheter placement or use of opioids or local anesthetic

2. Patients with contraindication to use of rescue analgesia like paracetamol and diclofenac both in postoperative period

3. Multiple incision not covered with epidural like TTE, THE

4. Patients with failed epidural insertion

5. Patients with epidural band not covering the incision sites completely

6. Patient with hemodynamic instability leading to inability to use epidural within the first 4-6 hours.

7. Patient shifted on ventilator or needing ventilator support the within first 6-12 hours.

-

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tata Memorial Centre

OTHER

Sponsor Role: lead

Responsible Party

parmanand jain

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Parmanand Jain, MD, MNAMS

Role: PRINCIPAL_INVESTIGATOR

Professor

Sumitra Bakshi, MD

Role: STUDY_CHAIR

Professor

Ankita Lapalikar, MBBS

Role: STUDY_CHAIR

Student

Locations

Tata Memorial Hospital

Mumbai, Maharashtra, India

Countries

India

References

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.

Reference Type: RESULT

PMID: 9523813 (View on PubMed)

Komatsu 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.

Reference Type: RESULT

PMID: 9768792 (View on PubMed)

Standl 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.

Reference Type: RESULT

PMID: 12620949 (View on PubMed)

Other Identifiers

1681

Identifier Type: -

Identifier Source: org_study_id