INFERTILITYAEDDATBNCT02838719
Analgesic Efficacy of Dexamethasone in Different Routes of Administration in Transverse Abdominis Plane Block
A study testing Perineural Dexamethasone acetate and Intravenous dexamethasone acetate in people with INFERTILITY, run by Post Graduate Institute of Medical Education and Research, Chandigarh.
Trial summary
Transverse abdominis plane (TAP) block is a regional anaesthesia technique that provides analgesia to the parietal peritoneum as well as skin and muscles of the anterior abdominal wall. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- INFERTILITY
- What is being tested?
- Perineural Dexamethasone acetate and Intravenous dexamethasone acetate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Dec 2014to Dec 2015
- Phase
- Interventional
- 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 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women aged between 18 to 70 years undergoing gynaecological laparoscopic surgeries under general anaesthesia
- ASA physical status1 or 2
Who cannot join
- Local infection
- Morbid obesity (body mass index >35kg/m2)
- Allergy to local anaesthetics
- Patient refusal
- Severe respiratory or cardiac disorders
- Pre-existing neurological deficits
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- Liver or renal insufficiency
- Preexisting diabetics
- Patient on steroid treatment for any reason.
- Peri Operative use of steroids
About this study
Official title: Effect of Perineural Versus Intravenous Dexamethasone On Analgesic Efficacy of Transverse Abdominis Plane Block With Levobupivacaine In Laparoscopic Gynaecological Procedures: A Randomized, Double-Blind Study
Transverse abdominis plane (TAP) block is a regional anaesthesia technique that provides analgesia to the parietal peritoneum as well as skin and muscles of the anterior abdominal wall. In the past, a number of adjuvants have been added to the local anaesthetics in peripheral and neuraxial blocks resulting in an effective and long lasting analgesia.In recent times, dexamethasone has been increasingly used as an adjuvant to local anaesthetics in peripheral nerve blocks. Dexamethasone has a long and efficient glucocorticoid structure and also has anti-inflammatory property. It also blocks the C- fibers of pain pathway. When added to local anaesthetics as an adjuvant in peripheral nerve blocks, it has shown to prolong the analgesia time. A number of previous studies have also shown an opioid sparing effect of steroids, when used intravenously perioperatively. Though previous studies have shown that addition of dexamethasone to local anaesthetics in transverse abdominis plane block prolongs the duration of block, however it is not known whether this effect of dexamethasone is due to its peripheral action or because of its systemic absorption. Thus, in this study planned to compare the effectiveness of dexamethasone on quality and duration of analgesia when used as an adjuvant with local anaesthetics in transverse abdominis plane block versus when given systemically by intravenous route along with transverse abdominis plane block using local anaesthetics only, in patients undergoing gynaecological laparoscopic procedures under general anaesthesia.
- Conditions
- INFERTILITY
- Being tested
- Perineural Dexamethasone acetate, Intravenous dexamethasone acetate
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Perineural Dexamethasone acetateDrug
Also called Decoin
Intravenous dexamethasone acetateDrug
Also called Decoin
| Study group | Role | What they receive |
|---|---|---|
| Perineural group | Experimental | Group 1: perineural dexamethasone acetate added to bilateral transverse abdominis plane block with levobupivacaine Receives: Drug: Perineural Dexamethasone acetate |
| Intravenous group | Active comparator | Group 2: Intravenous dexamethasone acetate added with bilateral transverse abdominal plane block with levobupivacaine Receives: Drug: Intravenous dexamethasone acetate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to first rescue analgesic
Pain will be assessed by vas score, if vas score more than 3 rescue analgesia will be given. Duration between the end of anaesthesia to first analgesic requirement during first 24 hours of postoperative period.
Measured: first 24 hours
Secondary outcomes (1)
Total amount of rescue analgesic required in 1st 24 hours postoperatively
Pain will be assessed by vas score, if vas score more than 3 rescue analgesia will be given.
Measured: 0, 0.25, 0.50, 0.75, 1 , 2, 4, 6, 8,12, 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2016 (estimated)
- Study startDec 2014
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for INFERTILITYStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, Chandigarh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vetriselvan p, Post Graduate Institute of Medical Education and Research, Chandigarh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02838719
- Sponsor's protocol ID
- PAIN86
- Acronym
- AEDDATB
- Status last verified
- Jul 2016
- First submitted
- 26 May 2016
- Last updated
- 20 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Perineural Versus Intravenous Dexamethasone On Analgesic Efficacy of Transverse Abdominis Plane Block With Levobupivacaine In Laparoscopic Gynaecological Procedures: A Randomized, Double-Blind Study
- ClinicalTrials.gov ID
- NCT02838719
- Acronym / sponsor ID
- AEDDATB / PAIN86
- Conditions
- INFERTILITY
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, ChandigarhUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 20 Jul 2016 (estimated)
- 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.
Transverse abdominis plane (TAP) block is a regional anaesthesia technique that provides analgesia to the parietal peritoneum as well as skin and muscles of the anterior abdominal wall. In the past, a number of adjuvants have been added to the local anaesthetics in peripheral and neuraxial blocks resulting in an effective and long lasting analgesia.In recent times, dexamethasone has been increasingly used as an adjuvant to local anaesthetics in peripheral nerve blocks. Dexamethasone has a long and efficient glucocorticoid structure and also has anti-inflammatory property. It also blocks the C- fibers of pain pathway. When added to local anaesthetics as an adjuvant in peripheral nerve blocks, it has shown to prolong the analgesia time. A number of previous studies have also shown an opioid sparing effect of steroids, when used intravenously perioperatively. Though previous studies have shown that addition of dexamethasone to local anaesthetics in transverse abdominis plane block prolongs the duration of block, however it is not known whether this effect of dexamethasone is due to its peripheral action or because of its systemic absorption. Thus, in this study planned to compare the effectiveness of dexamethasone on quality and duration of analgesia when used as an adjuvant with local anaesthetics in transverse abdominis plane block versus when given systemically by intravenous route along with transverse abdominis plane block using local anaesthetics only, in patients undergoing gynaecological laparoscopic procedures under general anaesthesia.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Perineural group | Experimental | Drug: Perineural Dexamethasone acetateGroup 1: perineural dexamethasone acetate added to bilateral transverse abdominis plane block with levobupivacaine |
| Intravenous group | Active comparator | Drug: Intravenous dexamethasone acetateGroup 2: Intravenous dexamethasone acetate added with bilateral transverse abdominal plane block with levobupivacaine |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Women aged between 18 to 70 years undergoing gynaecological laparoscopic surgeries under general anaesthesia
- ASA physical status1 or 2
Key exclusion criteria (10 listed)
- Local infection
- Morbid obesity (body mass index >35kg/m2)
- Allergy to local anaesthetics
- Patient refusal
- Severe respiratory or cardiac disorders
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 |
|---|---|---|
| Perineural Dexamethasone acetateAlso: Decoin | Drug | Perineural group |
| Intravenous dexamethasone acetateAlso: Decoin | Drug | Intravenous group |
Primary outcome
Time to first rescue analgesic
Time frame: first 24 hours
Pain will be assessed by vas score, if vas score more than 3 rescue analgesia will be given. Duration between the end of anaesthesia to first analgesic requirement during first 24 hours of postoperative period.
1 secondary outcome
Total amount of rescue analgesic required in 1st 24 hours postoperatively
Time frame: 0, 0.25, 0.50, 0.75, 1 , 2, 4, 6, 8,12, 24 hours
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 20 Jul 2016.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Perineural Dexamethasone acetate and Intravenous dexamethasone acetate in people with INFERTILITY, run by Post Graduate Institute of Medical Education and Research, Chandigarh.
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 2 inclusion and 10 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 20 Jul 2016. 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?
Time to first rescue analgesic (time frame: first 24 hours). 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 20 Jul 2016.