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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03145389
Other study ID # EC/1683
Secondary ID
Status Completed
Phase N/A
First received April 25, 2017
Last updated May 5, 2017
Start date March 20, 2016
Est. completion date April 20, 2017

Study information

Verified date May 2017
Source Banaras Hindu University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date April 20, 2017
Est. primary completion date April 20, 2017
Accepts healthy volunteers No
Gender All
Age group 20 Years to 60 Years
Eligibility 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 Design


Related Conditions & MeSH terms


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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Banaras Hindu University

Outcome

Type Measure Description Time frame Safety issue
Primary Return of bowel sound Earlier return of bowel sounds in epidural group Until 10th day after completion of surgery
Secondary Passage of flatus Earlier passage of flatus in epidural group Until 10th day after completion of surgery
Secondary Feed tolerance Earlier feed tolerance in epidural group Until 10th day after completion of surgery
Secondary Hospital discharge Earlier discharge from hospital in epidural group Until 10th day after completion of surgery
Secondary Post operative pain Lesser pain in epidural group Until 10th day after completion of surgery
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