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

May 5, 2017 updated by: Dr Lal Dhar Mishra, Banaras Hindu University

Effect of Continuous Thoracic Epidural Analgesia on Gut Motility Following Emergency Laparotomy for Intestinal Perforation Under General Anesthesia

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.

Study Overview

Status

Completed

Conditions

Detailed Description

Intestinal perforation is one of the commonest surgical emergency that the investigators encounter in emergency. Perioperative management of most of such patients is a challenging task for the anesthesiologist, as patients are often hemodynamically unstable at the time of their presentation to emergency. Usual plan of anesthesia for these patients is general anesthesia with or without an epidural block. In routine practice the investigators often place an epidural catheter, primarily for postoperative analgesia, unless there is some contraindication to epidural analgesia. Most often lower thoracic epidural is preferred because of longer length of the laparotomy incision. Thoracic epidural analgesia with local anesthetic (LA) is not only effective in managing the post-operative pain; it is also helpful in supplementing intra-operative analgesia with reduced requirement of anesthetic, muscle relaxant and the analgesic (opioid) drugs. In addition, it has also been reported to be associated with early return of gut motility.

It appears that absent / significantly reduced pain leads to lesser stress response, leading to less sympathetic activation and lesser catecholamine release. As catecholamines are inhibitory to gastrointestinal motility, earlier return of gastro intestinal (GI) motility can be achieved by reducing perioperative pain by continuous epidural analgesia. Moreover, an effective epidural analgesia with LA results in avoidance of opioid analgesics for optimal perioperative pain relief, which too may be helpful in achieving earlier return of gut motility.

Thus the investigators aimed at determining the effect of continuous thoracic epidural analgesia on return of gut motility in patients undergoing emergency exploratory laparotomy following intestinal perforation and compare it with those in whom epidural analgesia was not used.

Study Type

Observational

Enrollment (Actual)

60

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
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.
Without epidural catheter placement
In this group of patients epidural catheter was not inserted and post operative pain was managed by using intravenous drugs.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Return of bowel sound
Time Frame: Until 10th day after completion of surgery
Earlier return of bowel sounds in epidural group
Until 10th day after completion of surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Passage of flatus
Time Frame: Until 10th day after completion of surgery
Earlier passage of flatus in epidural group
Until 10th day after completion of surgery
Feed tolerance
Time Frame: Until 10th day after completion of surgery
Earlier feed tolerance in epidural group
Until 10th day after completion of surgery
Hospital discharge
Time Frame: Until 10th day after completion of surgery
Earlier discharge from hospital in epidural group
Until 10th day after completion of surgery
Post operative pain
Time Frame: Until 10th day after completion of surgery
Lesser pain in epidural group
Until 10th day after completion of surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Lal D Mishra, MD, PhD, Institute of Medical Sciences, Banaras HIndu University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 20, 2016

Primary Completion (Actual)

April 20, 2017

Study Completion (Actual)

April 20, 2017

Study Registration Dates

First Submitted

April 25, 2017

First Submitted That Met QC Criteria

May 5, 2017

First Posted (Actual)

May 9, 2017

Study Record Updates

Last Update Posted (Actual)

May 9, 2017

Last Update Submitted That Met QC Criteria

May 5, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EC/1683

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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