- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03145389
Effect of Continuous Thoracic Epidural Analgesia on Gut Motility Following Emergency Laparotomy
Effect of Continuous Thoracic Epidural Analgesia on Gut Motility Following Emergency Laparotomy for Intestinal Perforation Under General Anesthesia
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
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
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
Sponsor
Investigators
- Principal Investigator: Lal D Mishra, MD, PhD, Institute of Medical Sciences, Banaras HIndu University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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