Clinical trial NCT03145389: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Analgesia, Epidural
Lead sponsor: Banaras Hindu University
Sponsor class: OTHER
First posted: 2017-05-09
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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

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.

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

Primary outcomes:
measure: Return of bowel sound
timeFrame: Until 10th day after completion of surgery
Secondary outcomes:
measure: Passage of flatus
timeFrame: Until 10th day after completion of surgery
measure: Feed tolerance
timeFrame: Until 10th day after completion of surgery
measure: Hospital discharge
timeFrame: Until 10th day after completion of surgery
measure: Post operative pain
timeFrame: Until 10th day after completion of surgery
Other outcomes:
Locations:
Study officials:
affiliation: Institute of Medical Sciences, Banaras Hindu University
name: Lal D Mishra, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: