Effect of Continuous Thoracic Epidural Analgesia on Gut Motility Following Emergency Laparotomy

NCT03145389 | Completed DMC

• 1 other identifier: EC/1683
• Study Type: observational
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

Continuous thoracic epidural analgesia plays a very vital role in patients undergoing exploratory laparotomy. It not only supports a stable perioperative hemodynamics but also helps in early return of bowel activity.

Conditions

Analgesia, Epidural

Outcome Measures

Primary Outcomes (1)

• Return of bowel sound

  Earlier return of bowel sounds in epidural group

  Until 10th day after completion of surgery

Secondary Outcomes (4)

• Passage of flatus

  Until 10th day after completion of surgery

• Feed tolerance

  Until 10th day after completion of surgery

• Hospital discharge

  Until 10th day after completion of surgery

• Post operative pain

  Until 10th day after completion of surgery

Study Arms (2)

With epidural catheter placement

In this group of patients, after explaining about the procedure an 18 Gauge epidural catheter was placed in thoracic 11-12 inter vertebral space under strict asepsis.

Procedure: Epidural catheter placement

Without epidural catheter placement

In this group of patients epidural catheter was not inserted and post operative pain was managed by using intravenous drugs.

Interventions

Epidural catheter placement PROCEDURE

After explaining about the procedure an 18 Gauge epidural catheter was inserted into thoracic 11-12 inter vertebral space under strict asepsis. Before inserting the epidural needle same space was infiltrated with adequate amount of 2% Lignocaine with Adrenaline (1: 200,000) to make the procedure pain free. Epidural space was confirmed by loss of resistance technique.

With epidural catheter placement

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Selected patients were randomly divided into two groups of 30 patients each, * Group-Ι : Epidural group * Group-ΙΙ: Non epidural group

You may qualify if:

• Both sexes
• Age 20-60 years
• Intestinal perforation posted for emergency exploratory laparotomy

You may not qualify if:

• Patient's refusal and uncooperativeness for epidural analgesia
• Hemodynamically unstable patients
• Patients with coagulation disorder
• Infection at the site of epidural insertion
• Spine deformity or spinal cord disease
• Raised intracranial pressure
• History of drug abuse
• Other comorbid conditions like diabetes mellitus, hypertension, thyroid disease

Sponsors & Collaborators

• Banaras Hindu University: lead

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Lal D Mishra, MD, PhD

  Institute of Medical Sciences, Banaras Hindu University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior professor, Ex head of the department, Principal investigator, Department of Anesthesiology

Study Record Dates

• First Submitted: April 25, 2017
• First Posted: May 9, 2017
• Study Start: March 20, 2016
• Primary Completion: April 20, 2017
• Study Completion: April 20, 2017
• Last Updated: May 9, 2017

Record last verified: 2017-05