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

NCT02803385 | Completed DMC

• 1 other identifier: 1681
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain

Keywords

Patient Controlled Epidural Analgesia; Continous Epidural Infusion Analgesia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

Study Arms (2)

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

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 .

Other: Patient Controlled Epidural Analgesia

Interventions

Continous Epidural Analgesia 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.

Also known as: continous epidural infusion of local anesthetic with opioid

Continous Epidural Analgesia

Patient Controlled Epidural Analgesia 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.

Also known as: patient controlled boluses of local anesthetic with opioid

Patient Controlled Epidural Analgesia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tata Memorial Centre: lead

Study Sites (1)

Tata Memorial Hospital

Mumbai, Maharashtra, 400012, India

Location

Related Publications (3)

• 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.

  PMID: 9523813 RESULT

• 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.

  PMID: 9768792 RESULT

• 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.

  PMID: 12620949 RESULT

MeSH Terms

Conditions

Pain

Interventions

Analgesics, Opioid

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Narcotics; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Central Nervous System Agents; Therapeutic Uses

Study Officials

• Parmanand Jain, MD, MNAMS

  Professor

  PRINCIPAL INVESTIGATOR

• Sumitra Bakshi, MD

  Professor

  STUDY CHAIR

• Ankita Lapalikar, MBBS

  Student

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 8, 2016
• First Posted: June 17, 2016
• Study Start: July 1, 2016
• Primary Completion: December 1, 2018
• Study Completion: January 1, 2019
• Last Updated: October 6, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)