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NCT Number: NCT03145389

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Epidural catheter placement

Procedure

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.

Primary outcomes

  1. Return of bowel sound

    Time frame: Until 10th day after completion of surgery

    Earlier return of bowel sounds in epidural group

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Banaras Hindu University

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
May 9, 2017
Registry last updated
May 9, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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