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

• ClinicalTrials.gov Identifier: NCT03145389
• Recruitment Status: Completed
• First Posted: May 9, 2017
• Last Update Posted: May 9, 2017
• Sponsor: Banaras Hindu University
• Information provided by (Responsible Party): Dr Lal Dhar Mishra, Banaras Hindu University

Study Description

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.

Condition or disease	Intervention/treatment
Analgesia, Epidural	Procedure: Epidural catheter placement

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 Design

• Study Type: Observational
• Actual Enrollment: 60 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: Effect of Continuous Thoracic Epidural Analgesia on Gut Motility Following Emergency Laparotomy for Intestinal Perforation Under General Anesthesia
• Actual Study Start Date: March 20, 2016
• Actual Primary Completion Date: April 20, 2017
• Actual Study Completion Date: April 20, 2017

Groups and Cohorts

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.	Procedure: Epidural catheter placement; 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.

Outcome Measures

Primary Outcome Measures :

1. Return of bowel sound [ Time Frame: Until 10th day after completion of surgery ]
   Earlier return of bowel sounds in epidural group

Secondary Outcome Measures :

1. Passage of flatus [ Time Frame: Until 10th day after completion of surgery ]
   Earlier passage of flatus in epidural group
2. Feed tolerance [ Time Frame: Until 10th day after completion of surgery ]
   Earlier feed tolerance in epidural group
3. Hospital discharge [ Time Frame: Until 10th day after completion of surgery ]
   Earlier discharge from hospital in epidural group
4. Post operative pain [ Time Frame: Until 10th day after completion of surgery ]
   Lesser pain in epidural group

Eligibility Criteria

• Ages Eligible for Study: 20 Years to 60 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• 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

Criteria

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

Contacts and Locations

Sponsors and Collaborators

Banaras Hindu University

Investigators

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

More Information

• Responsible Party: Dr Lal Dhar Mishra, Senior professor, Ex head of the department, Principal investigator, Department of Anesthesiology, Banaras Hindu University
• ClinicalTrials.gov Identifier: NCT03145389
• Other Study ID Numbers: EC/1683
• First Posted: May 9, 2017
• Last Update Posted: May 9, 2017
• Last Verified: May 2017

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Emergencies; Disease Attributes; Pathologic Processes