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Post Operative PainEarly Phase 1NCT04620720

Post Operative Pain in Modified Radical Mastectomy.

A Early Phase 1 study testing capule gabapentin in people with Post Operative Pain, run by Combined Military Hospital, Pakistan at 1 site in Pakistan.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

we will assess post operative pain after surgery of modified radical mastectomy at 12 and 24 hours post operatively on arm movement and on rest Read more about this study

Who is it for?
Ages 18 to 80 years, women onlyHealthy volunteers can take part
Conditions the study is for
Post Operative Pain
What is being tested?
capule gabapentin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
51 participants
Where
1 sitePakistan
Study dates
1 Aug 2020to 1 Dec 2020
Phase
Early Phase 1
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 80 years
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • All Females, age ranged between 20 to 80 years and diagnosed with breast carcinoma stage II on the basis of triple assessment will be recruited in the study

Who cannot join

  • Patients who will refuse to participate in the study, allergic to gabapentin on the basis if history, previous treatment with Gabapentin in previous 8 weeks , Chronic pain syndrome, Substance abuse, sedatives, hypnotics or antidepressants ,analgesic intake within 48 hours before surgery, Diabetes mellitus, Hypertension and Acute or Chronic Renal Failure on the basis of medical records

Trial locations and contacts

1 site in 1 country.

Anum Arif, MBBS FCPS contact

+923422398424

dranumarif@yahoo.com

Ammad Asim, MBBS FCPS contact

+923422398424

ammadasim@gmail.com

Pakistan1 site, 1 recruiting
  • Anum

    Karachi, Select A State Or Province, 00921

    Anum Arif, MBBS FCPS, 03422398424, dranumarif@yahoo.com

    ammad asim, MBBS FCPS, +923422398424, AMMADASIM@GMAIL.COM

    Recruiting

Other trials in Pakistan

About this study

we will assess post operative pain after surgery of modified radical mastectomy at 12 and 24 hours post operatively on arm movement and on rest

Read the detailed description

This Randomised control trial will be conducted at the Department of General Surgery, Dow University Hospital OJHA Campus Karachi over a period of a year. All Females, ages ranged between 20 to 80 years and diagnosed with breast carcinoma stage II on the basis of triple assessment will be recruited in the study. Patients who will refuse to participate in the study, allergic to gabapentin on the basis if history, previous treatment with Gabapentin in the previous 8 weeks, Chronic pain syndrome, Substance abuse, sedatives, hypnotics or antidepressants, analgesic intake within 48 hours before surgery, Diabetes mellitus, Hypertension, and Acute or Chronic Renal Failure on the basis of medical records and Inability to understand VAS pain score will be excluded from the study. The sample size will be calculated by the Open Epi calculator. The mean pain score difference at rest between two groups was taken as 0.7 (Placebo: mean ± SD = 2.9 ± 1.2 and Gabapentin: mean ± SD = 2.2 ± 1.3.5 With 80% power, and 95% confidence level, the total sample size came out to be 102, 51 patients in each group. Consecutive sampling was used to achieve the desired sample. Patients fulfilling inclusion criteria were randomly enrolled in either of the 2 groups by sealed opaque envelop method bearing cards, which will be picked by the staff nurses. The intervention group was labeled as group A and the control group as group B. Patients in the intervention group received a single dose of 1200 mg of gabapentin 2hours before surgery. All procedures were performed under general anesthesia. Postoperative analgesic injection ketorolac 30 mg thrice a day and injection paracetamol 1 gram intravenous thrice a day was advised. Patients were assessed at 12 and 24 h post-operatively for pain scores at rest and arm mobilization using VAS pain score, a number of times rescue analgesia when VAS score > 3 by residents of surgery blinded to the study. Those patients, who experience pain (pain score > 3) in spite of routine analgesics received injection ketorolac 30 mg once, pain score between 3 to 6 received injection Kinz, pain score > 7 will be given both analgesics single times, pain score >8 will receive intravenous maximum thrice in 24 hours. Patients with pain score 0-2 will not be given any additional analgesic All patients will receive antiemetic in Metoclopramide 10 mg I.V in case of nausea and vomiting. All demographics and outcome variables will be entered in the proforma. The outcome variables of the study were age, pain score (VAS), and analgesic requirement.

Being tested
capule gabapentin
Medical subject headings
Pain, Postoperative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • capule gabapentinDrug

    neuropathic analgesic

Study groups in NCT04620720
Study groupRoleWhat they receive
control groupNo interventionroutuine analgesics wil be given
intervention groupExperimentalpatient will receive cap gabapentin 1200 mg 2 hours before surgery
Receives: Drug: capule gabapentin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. post operative pain score

    Visual analog score for pain from 0 to 10. O means no pain. 1 is least and 10 is most severe pain

    Measured: 12 hours post oepratively

Secondary outcomes (1)
  1. analgesia requirement

    change in analgesic requirement a i either groups

    Measured: 12 hours post oepratively

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Nov 2020
  2. Study start1 Aug 2020
  3. Primary completion1 Dec 2020 (estimated)
  4. Study completion1 Dec 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Single group
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
51 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04620720
Sponsor's protocol ID
DUHSKK
Status last verified
Nov 2020
First submitted
4 Nov 2020
Last updated
9 Nov 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing capule gabapentin in people with Post Operative Pain, run by Combined Military Hospital, Pakistan at 1 site in Pakistan.

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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 9 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.

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.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Anum Arif, MBBS FCPS (+923422398424, dranumarif@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

post operative pain score (time frame: 12 hours post oepratively). 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 Nov 2020.

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