Comparison of the Incidence of Inadequate Epidural Analgesia Between Protocol Based and Current Practice

NCT04111406 | Terminated DMC

• 1 other identifier: Si 342/2018
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

Epidural analgesia is the recommended analgesic technique in patients having surgery with severe postoperative pain such as thoracic and upper abdominal surgery. However, from the previous study, the incidence of inadequate pain control in patients receiving epidural analgesia is very high 48.6% in our hospital.

Conditions

Epidural Analgesia; Postoperative Pain

Keywords

Epidural Analgesia; Postoperative Pain

Outcome Measures

Primary Outcomes (1)

• Overall incidence of inadequate epidural analgesia

  To compare the overall incidence of inadequate epidural analgesia until considered removal between protocol-based and current practice by using the definition of inadequate analgesia as pain score of 4 or more out of 10 on numeric rating scale (0; no pain, 10; worst imaginable pain) at rest.

  72 hours

Secondary Outcomes (1)

• Side effects

  72 hours

Study Arms (2)

Current practice

OTHER

Epidural insertion and epidural drug administration depend on anesthetist in charge

Drug: Current practice

Protocol based

EXPERIMENTAL

Epidural insertion and epidural drug administration depend on anesthetist in research team using protocol based

Drug: Protocol based

Interventions

Current practice DRUG

Epidural insertion and epidural drug administration depend on anesthetist in charge

Current practice

Protocol based DRUG

Epidural insertion and epidural drug administration depend on anesthetist in research team using protocol based 1. insertion at mid-level of surgical insertion 2. insertion depth is 3-5 cm in space, not more than 5 cm 3. using benzoin tincture and transparent dressing to fix catheter 4. test dose with 2%xylocaine with adrenaline 1:200,000 3ml If not cover desired dermatome: 2% lidocaine with adr added 3 ml every 5 min (up to 2 times) 5. After induction and patients' hemodynamic are stable. Load 2 mg morphine with 0.0625% bupivacaine + morphine 0.02 mg/ml 3 ml then continuous infusion with rate according to initial local anesthetic requirement for incisional area coverage

Protocol based

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients age ≥ 18 years old undergo surgery with epidural catheter insertion at Siriraj hospital.

You may not qualify if:

• Coagulopathy
• Allergy to study drugs: local anesthetics and opioids
• History of chronic pain

Sponsors & Collaborators

• Mahidol University: lead

Study Sites (1)

Siriraj hospital

Bangkok, 10700, Thailand

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Pawinee Pangthipampai, M.D.

  Siriraj Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Historical control study (Before and after study) Data in current practice was derived from acute pain record before Jan 2019

Study Record Dates

• First Submitted: September 29, 2019
• First Posted: October 1, 2019
• Study Start: January 9, 2019
• Primary Completion: October 28, 2021
• Study Completion: October 28, 2021
• Last Updated: July 26, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)