Analgesia, EpiduralNCT03145389
Effect of Continuous Thoracic Epidural Analgesia on Gut Motility Following Emergency Laparotomy
An observational study of Analgesia, Epidural, run by Banaras Hindu University.
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. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Analgesia, Epidural
- What is being tested?
- Epidural catheter placement
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 20 Mar 2016to 20 Apr 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Selected patients were randomly divided into two groups of 30 patients each, * Group-Ι : Epidural group * Group-ΙΙ: Non epidural group
Who may be able to join
- Both sexes
- Age 20-60 years
- Intestinal perforation posted for emergency exploratory laparotomy
Who cannot join
- 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
About this study
Official title: Effect of Continuous Thoracic Epidural Analgesia on Gut Motility Following Emergency Laparotomy for Intestinal Perforation Under General Anesthesia
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.
Read the 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.
- Conditions
- Analgesia, Epidural
- Being tested
- Epidural catheter placement
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epidural catheter placementProcedure or surgery
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Return of bowel sound
Earlier return of bowel sounds in epidural group
Measured: Until 10th day after completion of surgery
Secondary outcomes (4)
Passage of flatus
Earlier passage of flatus in epidural group
Measured: Until 10th day after completion of surgery
Feed tolerance
Earlier feed tolerance in epidural group
Measured: Until 10th day after completion of surgery
Hospital discharge
Earlier discharge from hospital in epidural group
Measured: Until 10th day after completion of surgery
Post operative pain
Lesser pain in epidural group
Measured: Until 10th day after completion of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2017
- Study start20 Mar 2016
- Primary completion20 Apr 2017
- Study completion20 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Analgesia, EpiduralStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Banaras Hindu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Lal Dhar Mishra, Banaras Hindu University
- Investigators
- Lal D Mishra, MD, PhD, Principal investigator, Institute of Medical Sciences, Banaras Hindu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03145389
- Sponsor's protocol ID
- EC/1683
- Status last verified
- May 2017
- First submitted
- 25 Apr 2017
- Last updated
- 9 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Continuous Thoracic Epidural Analgesia on Gut Motility Following Emergency Laparotomy for Intestinal Perforation Under General Anesthesia
- ClinicalTrials.gov ID
- NCT03145389
- Acronym / sponsor ID
- EC/1683
- Conditions
- Analgesia, Epidural
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Banaras Hindu UniversityUniversity, hospital or other
- Study start
- 20 Mar 2016 (actual)
- Primary completion
- 20 Apr 2017 (actual)
- Study completion
- 20 Apr 2017 (actual)
- First posted
- 9 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| With epidural catheter placement | – | Procedure: Epidural catheter placementIn 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. |
| Without epidural catheter placement | – | –In this group of patients epidural catheter was not inserted and post operative pain was managed by using intravenous drugs. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Selected patients were randomly divided into two groups of 30 patients each, * Group-Ι : Epidural group * Group-ΙΙ: Non epidural group
Key inclusion criteria (3 listed)
- Both sexes
- Age 20-60 years
- Intestinal perforation posted for emergency exploratory laparotomy
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Epidural catheter placementAfter 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. | Procedure or surgery | With epidural catheter placement |
Primary outcome
Return of bowel sound
Time frame: Until 10th day after completion of surgery
Earlier return of bowel sounds in epidural group
4 secondary outcomes
Passage of flatus
Time frame: Until 10th day after completion of surgery
Feed tolerance
Time frame: Until 10th day after completion of surgery
Hospital discharge
Time frame: Until 10th day after completion of surgery
Post operative pain
Time frame: Until 10th day after completion of surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2017.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lal D Mishra, MD, PhD principal investigator
Institute of Medical Sciences, Banaras Hindu University
Questions about this trial
What is this clinical trial studying?
An observational study of Analgesia, Epidural, run by Banaras Hindu University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 May 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Return of bowel sound (time frame: Until 10th day after completion of surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2017.