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

Pain Clinical Trial

Official title:

Comparison of Efficacy of Patient Controlled Epidural Analgesia Versus Continuous Epidural Infusion Following Thoraco-abdominal Surgeries in Cancer Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02803385
• Other study ID #: 1681
• Status: Completed
• Phase: N/A
• Start date: July 2016
• Est. completion date: January 2019

Study information

• Verified date: October 2021
• Source: Tata Memorial Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: January 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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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Related Conditions & MeSH terms

• Pain

Intervention

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.
• 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.

Locations

Country	Name	City	State
India	Tata Memorial Hospital	Mumbai	Maharashtra

Sponsors (1)

Lead Sponsor	Collaborator
Tata Memorial Centre

Country where clinical trial is conducted

India, 

References & Publications (3)

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. — View Citation

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. — View Citation

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 Anaes — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	To compare patient satisfaction between the two groups using Verbal Rating scale		36 hours and 72 hours
Secondary	To assess the incidence of side effects in both groups including hypotension, motor weakness, pruritus, nausea, vomiting and any other		72 hours