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

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.

Study Overview

• Status: Completed
• Conditions: Pain
• Intervention / Treatment: Other: Continous Epidural Analgesia; Other: Patient Controlled Epidural Analgesia

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.

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Maharashtra
    • Mumbai, Maharashtra, India, 400012
      • Tata Memorial hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

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Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: 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	Other: 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.; Other Names: continous epidural infusion of local anesthetic with opioid
ACTIVE_COMPARATOR: 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 .	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.; Other Names: patient controlled boluses of local anesthetic with opioid

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	72 hours

Secondary Outcome Measures

Outcome Measure	Time Frame
To compare patient satisfaction between the two groups using Verbal Rating scale	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	72 hours

Collaborators and Investigators

• Sponsor: Tata Memorial Centre
• Investigators: Principal Investigator: Parmanand Jain, MD, MNAMS, Professor; Study Chair: Sumitra Bakshi, MD, Professor; Study Chair: Ankita Lapalikar, MBBS, Student

Publications and helpful links

General 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 1, 2016
• Primary Completion (ACTUAL): December 1, 2018
• Study Completion (ACTUAL): January 1, 2019

Study Registration Dates

• First Submitted: June 8, 2016
• First Submitted That Met QC Criteria: June 13, 2016
• First Posted (ESTIMATE): June 17, 2016

Study Record Updates

• Last Update Posted (ACTUAL): October 6, 2021
• Last Update Submitted That Met QC Criteria: October 5, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: Patient Controlled Epidural Analgesia; Continous Epidural Infusion Analgesia
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Narcotics; Anesthetics; Anesthetics, Local; Analgesics, Opioid
• Other Study ID Numbers: 1681

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO