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

Tracking Information

• First Submitted Date: April 25, 2017
• First Posted Date: May 9, 2017
• Last Update Posted Date: May 9, 2017
• Actual Study Start Date: March 20, 2016
• Actual Primary Completion Date: April 20, 2017 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: May 5, 2017)

Return of bowel sound [ Time Frame: Until 10th day after completion of surgery ]

Earlier return of bowel sounds in epidural group

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: May 5, 2017)

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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Effect of Continuous Thoracic Epidural Analgesia on Gut Motility Following Emergency Laparotomy
• Official Title: Effect of Continuous Thoracic Epidural Analgesia on Gut Motility Following Emergency Laparotomy for Intestinal Perforation Under General Anesthesia
• 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.

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
• Study Design: Observational Model: Case-Control; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• 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

• Condition: Analgesia, Epidural

Intervention

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.

Study Groups/Cohorts

• 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.
  Intervention: 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.

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: May 5, 2017): 60
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: April 20, 2017
• Actual Primary Completion Date: April 20, 2017 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 20 Years to 60 Years (Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT03145389
• Other Study ID Numbers: EC/1683
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

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

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Current Responsible Party: Dr Lal Dhar Mishra, Banaras Hindu University
• Original Responsible Party: Same as current
• Current Study Sponsor: Banaras Hindu University
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

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

• PRS Account: Banaras Hindu University
• Verification Date: May 2017