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

NCT ID: NCT04111406

Last Updated: 2022-07-26

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-09
• Study Completion Date: 2021-10-28

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.

Detailed Description

A high incidence of inadequate epidural analgesia may result from variety of epidural techniques and epidural drug administrations. The protocol based practice has been developed from acute pain service which founded for more than 10 years. By using protocol based practice, the investigators believed that the incidence of inadequate epidural analgesia will be less compared with the current practice.

Conditions

Epidural Analgesia; Postoperative Pain

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Current practice

Epidural insertion and epidural drug administration depend on anesthetist in charge

Group Type: OTHER

Current practice

Intervention Type: DRUG

Epidural insertion and epidural drug administration depend on anesthetist in charge

Protocol based

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

Group Type: EXPERIMENTAL

Protocol based

Intervention Type: 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

Interventions

Current practice

Epidural insertion and epidural drug administration depend on anesthetist in charge

Intervention Type: DRUG

Protocol based

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Mahidol University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pawinee Pangthipampai, M.D.

Role: PRINCIPAL_INVESTIGATOR

Siriraj Hospital

Locations

Siriraj hospital

Bangkok, , Thailand

Countries

Thailand

Other Identifiers

Si 342/2018

Identifier Type: -

Identifier Source: org_study_id