Pain Relief in Post Operative PatientEarly Phase 1NCT05244252
Comparison of Pain ReliefofBupivacaineWith Dexmedetomidine and Bupivacaine Alone in TransversusAbdominisPlane Block For Postoperative Anelgesia in Patients Undergoing Abdominal Surgeries
A Early Phase 1 study testing dexmeditomidine and bupivacaine and Bupivacaine in people with Pain Relief in Post Operative Patient, run by Sheikh Zayed Medical College at 1 site in Pakistan.
Trial summary
Postoperative pain related to abdominal surgeries poses significant burden on the healthcare system, in terms of increased use of different analgesics, delayed ambulation, pulmonary complications, DVT, and prolonged hospital stays. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain Relief in Post Operative Patient
- What is being tested?
- dexmeditomidine and bupivacaine and Bupivacaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 sitePakistan
- Study dates
- 4 Oct 2021to 10 Apr 2022
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients who will give written informed consent
- ASA I \&II
- Age between 21-45 years
- Patients undergoing abdominal surgeries
- Patients understanding VAS
Who cannot join
- Patients allergic to bupivacaine or dexmeditomidine
- Complicated procedure
- History of coagulopathy
- History of chronic use of pain medications
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Alina Zafar
Rahim Yar Khan, Punjab Province, 64200
alina zafar, MBBS, +923126555448, docaleena786@gmail.com
About this study
Official title: Dexmed Vs Bupivacaine
Postoperative pain related to abdominal surgeries poses significant burden on the healthcare system, in terms of increased use of different analgesics, delayed ambulation, pulmonary complications, DVT, and prolonged hospital stays. Abdominal wall is major source of pain and there have been much debate in the past to bring up the effective, low cost and prolong pain relief to the patients after abdominal surgeries. But yet a consensus has to be developed about which analgesic to be used for most efficient and prolonged pain relief. Though, many studies have been done on TAP block and different combinations have been tried in TAP block, like, dexmedetomidine, midazolam, ropivacaine, but we still lack local data. Recent studies have shown very promising results in terms of efficacy and duration of block by mixing bupivacaine with dexmedetomidine, alongwith minimal side effects to the patients.
This randomised control trial will enroll 88 patients coming to Anesthesia department of Sheikh Zayed Hospital Rahim Yar Khan, for abdominal surgeries, judged on the basis of inclusion and exclusion criteria, into two groups of equal sizes. TAP block will be given to all patients bilaterally at the end of procedure after extubation in operation room. One group will be given bupivacainemixed with dexmedetomidine, while the other group will receive bupivacaine only, and they will be followed upto 12 hours postoperatively in post surgical ICU. Study protocol will be according to the ethical standards declared by Helsinki. For both the groups, HR, BP, SpO2,VAS score,rescue analgesia and sedation score stated on the clinical proforma will be assessed. After appropriate sample collection,patient data will be sorted in SPSS v23 through which statistical analysis using corresponding statistical functions and tests will be done.Quantitative data (like heart rate, mean arterial pressure, VAS score etc.) will be analysed using t-test. For qualitative variable(pain relief, bradycardia nausea etc.)chi-square test will be applied. P value </= 0.05 will be considered significant. Results of the study will be summarized and presented in final thesis.
Read the detailed description
Introduction:
Pain is defined as, "an unpleasant sensory and emotional experience associated with actual or potential tissue damage or described in terms of such damage" by the international association for the study of pain. Postoperative suboptimal analgesia has very pronounced effects on the wellbeing of the patient. Patients have experienced delayed mobility, thromboembolic phenomenon, and pulmonary complications.It not only leads to prolonged stay due to delayed ambulation but also basal lung atelectasis and collapse from limited chest expansion after abdominal incision. The abdominal wall is a significant source of pain after abdominal surgery. Expected pain prevalence after hernia repair was determined as 54% and postoperative 2-year cumulative prevalence was found to be 30%.
Many methods to efficiently combat post-operative pain have been tried in the past. The multimodal approach of pain management as defined by the American Society of Anaesthesiology (ASA2012) is the administration of two or more drugs that act by different mechanisms via the same route or different route to provide optimal analgesia.Patient-controlled thoracic epidural, intravenous patient-controlled analgesia the intraperitoneal injection of local anesthetics, non-steroidal anti-inflammatory drugs, and opioids have all been part of it in different combinations.
Over the past years, the ideology of pain management has evolved from mere decreasing pain intensity to optimizing a patient's condition. The mainstay of this is to work particularly in two areas; decreasing pain scores and stress response, together with a decrease in analgesic-related side effects like nausea vomiting, and sedation. Systemic opioids have been the mainstay for postoperative analgesia for a long; but at the expense of adverse effects of nausea, vomiting, pruritus, sedation, and respiratory depression. All these issues have led to the continuous search for a better,safer, and long-lasting alternative for post-op analgesia. Though much work has been done for better understanding of the pathophysiology of postoperative pain along with the introduction of modern analgesics and delivery techniques;yet approximately 80% of the patients continue to suffer acute postoperative pain and among them, 75% experienced moderate to severe pain.
TAP block provides regional analgesia in dermatome area over T6-L1. It was initially started with the landmark technique, through lumber triangle of petit formed by external oblique muscle anteriorly, latissimussdorsi posteriorly, iliac crest inferiorly and is usually identified as a defect as 1 cam above the iliac crest in mid-axillary line. Quite several previous studies on TAP block have shown favourable results in terms of post-op pain relief, but the duration of analgesia remains an unsolved concern.Different adjuncts have been tried with bupivacaine to achieve this desired goal of long-lasting post-op analgesia with minimal side effects. Among those many studies have been done using dexamethasone,midazolam,ropivacaine, anddexmedetomidine.
Rationale:
The rationale of the study is to find out the effect of the addition of dexmedetomidine to bupivacaine on pain relief, and the demand for rescue analgesia on patients undergoing abdominal surgeries in Sheikh Zayed Hospital Rahim Yar Khan, when used in TAP block.
Past studies have shown encouraging results with the use of TAP block with or without dexmedetomidine; however, we lack local data concerning especially the patients undergoing abdominal procedures. Despite many studies performed on postoperative pain control we still have not attained gold standard criteria of multi-modal pain relief with minimal undesired effects on patients. This experimental study will pick the difference in postoperative pain relief by adding this adjunct to bupivacaine.
- Conditions
- Pain Relief in Post Operative Patient
- Being tested
- dexmeditomidine and bupivacaine, Bupivacaine
- Keywords
- Dexmeditomidine, bupivacaine, VAS, remsay sedation score
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dexmeditomidine and bupivacaineDrug
Transversus abdominis plane block will be given bilaterally
BupivacaineDrug
bupivacaine
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Two drugs dexmeditomidine and bupivacaine will be given in TAP block Receives: Drug: dexmeditomidine and bupivacaine |
| Group B | Active comparator | One drug bupivacaine will be given in TAP block Receives: Drug: Bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analogue score
It is a scale from 0-10 showing minimal pain on 0 and maximum pain on 10. This score is classified in to 5 categories. 0 No Pain 1-3 Mild Pain 4-6 Moderate Pain 7-9 Severe Pain 10 very severe
Measured: 12 hours post operative pain will be followed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2022
- Study start4 Oct 2021
- Primary completion3 Mar 2022
- Study completion10 Apr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain Relief in Post Operative PatientStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two groups of equal size will be included in study
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheikh Zayed Medical College
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Alina Zafar, Sheikh Zayed Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05244252
- Sponsor's protocol ID
- SZMC
- Status last verified
- Mar 2022
- First submitted
- 8 Feb 2022
- Last updated
- 7 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plans
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dexmed Vs Bupivacaine
- ClinicalTrials.gov ID
- NCT05244252
- Acronym / sponsor ID
- SZMC
- Conditions
- Pain Relief in Post Operative Patient
- Keywords
- Dexmeditomidine, bupivacaine, VAS, remsay sedation score
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Sheikh Zayed Medical CollegeOther government
- Study start
- 4 Oct 2021 (actual)
- Primary completion
- 3 Mar 2022 (actual)
- Study completion
- 10 Apr 2022 (estimated)
- First posted
- 17 Feb 2022 (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.
Postoperative pain related to abdominal surgeries poses significant burden on the healthcare system, in terms of increased use of different analgesics, delayed ambulation, pulmonary complications, DVT, and prolonged hospital stays. Abdominal wall is major source of pain and there have been much debate in the past to bring up the effective, low cost and prolong pain relief to the patients after abdominal surgeries. But yet a consensus has to be developed about which analgesic to be used for most efficient and prolonged pain relief. Though, many studies have been done on TAP block and different combinations have been tried in TAP block, like, dexmedetomidine, midazolam, ropivacaine, but we still lack local data. Recent studies have shown very promising results in terms of efficacy and duration of block by mixing bupivacaine with dexmedetomidine, alongwith minimal side effects to the patients.
This randomised control trial will enroll 88 patients coming to Anesthesia department of Sheikh Zayed Hospital Rahim Yar Khan, for abdominal surgeries, judged on the basis of inclusion and exclusion criteria, into two groups of equal sizes. TAP block will be given to all patients bilaterally at the end of procedure after extubation in operation room. One group will be given bupivacainemixed with dexmedetomidine, while the other group will receive bupivacaine only, and they will be followed upto 12 hours postoperatively in post surgical ICU. Study protocol will be according to the ethical standards declared by Helsinki. For both the groups, HR, BP, SpO2,VAS score,rescue analgesia and sedation score stated on the clinical proforma will be assessed. After appropriate sample collection,patient data will be sorted in SPSS v23 through which statistical analysis using corresponding statistical functions and tests will be done.Quantitative data (like heart rate, mean arterial pressure, VAS score etc.) will be analysed using t-test. For qualitative variable(pain relief, bradycardia nausea etc.)chi-square test will be applied. P value </= 0.05 will be considered significant. Results of the study will be summarized and presented in final thesis.
Detailed description
Introduction:
Pain is defined as, "an unpleasant sensory and emotional experience associated with actual or potential tissue damage or described in terms of such damage" by the international association for the study of pain. Postoperative suboptimal analgesia has very pronounced effects on the wellbeing of the patient. Patients have experienced delayed mobility, thromboembolic phenomenon, and pulmonary complications.It not only leads to prolonged stay due to delayed ambulation but also basal lung atelectasis and collapse from limited chest expansion after abdominal incision. The abdominal wall is a significant source of pain after abdominal surgery. Expected pain prevalence after hernia repair was determined as 54% and postoperative 2-year cumulative prevalence was found to be 30%.
Many methods to efficiently combat post-operative pain have been tried in the past. The multimodal approach of pain management as defined by the American Society of Anaesthesiology (ASA2012) is the administration of two or more drugs that act by different mechanisms via the same route or different route to provide optimal analgesia.Patient-controlled thoracic epidural, intravenous patient-controlled analgesia the intraperitoneal injection of local anesthetics, non-steroidal anti-inflammatory drugs, and opioids have all been part of it in different combinations.
Over the past years, the ideology of pain management has evolved from mere decreasing pain intensity to optimizing a patient's condition. The mainstay of this is to work particularly in two areas; decreasing pain scores and stress response, together with a decrease in analgesic-related side effects like nausea vomiting, and sedation. Systemic opioids have been the mainstay for postoperative analgesia for a long; but at the expense of adverse effects of nausea, vomiting, pruritus, sedation, and respiratory depression. All these issues have led to the continuous search for a better,safer, and long-lasting alternative for post-op analgesia. Though much work has been done for better understanding of the pathophysiology of postoperative pain along with the introduction of modern analgesics and delivery techniques;yet approximately 80% of the patients continue to suffer acute postoperative pain and among them, 75% experienced moderate to severe pain.
TAP block provides regional analgesia in dermatome area over T6-L1. It was initially started with the landmark technique, through lumber triangle of petit formed by external oblique muscle anteriorly, latissimussdorsi posteriorly, iliac crest inferiorly and is usually identified as a defect as 1 cam above the iliac crest in mid-axillary line. Quite several previous studies on TAP block have shown favourable results in terms of post-op pain relief, but the duration of analgesia remains an unsolved concern.Different adjuncts have been tried with bupivacaine to achieve this desired goal of long-lasting post-op analgesia with minimal side effects. Among those many studies have been done using dexamethasone,midazolam,ropivacaine, anddexmedetomidine.
Rationale:
The rationale of the study is to find out the effect of the addition of dexmedetomidine to bupivacaine on pain relief, and the demand for rescue analgesia on patients undergoing abdominal surgeries in Sheikh Zayed Hospital Rahim Yar Khan, when used in TAP block.
Past studies have shown encouraging results with the use of TAP block with or without dexmedetomidine; however, we lack local data concerning especially the patients undergoing abdominal procedures. Despite many studies performed on postoperative pain control we still have not attained gold standard criteria of multi-modal pain relief with minimal undesired effects on patients. This experimental study will pick the difference in postoperative pain relief by adding this adjunct to bupivacaine.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Two groups of equal size will be included in study
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Drug: dexmeditomidine and bupivacaineTwo drugs dexmeditomidine and bupivacaine will be given in TAP block |
| Group B | Active comparator | Drug: BupivacaineOne drug bupivacaine will be given in TAP block |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Patients who will give written informed consent
- ASA I \&II
- Age between 21-45 years
- Patients undergoing abdominal surgeries
- Patients understanding VAS
Key exclusion criteria (4 listed)
- Patients allergic to bupivacaine or dexmeditomidine
- Complicated procedure
- History of coagulopathy
- History of chronic use of pain medications
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 |
|---|---|---|
| dexmeditomidine and bupivacaineTransversus abdominis plane block will be given bilaterally | Drug | Group A |
| Bupivacainebupivacaine | Drug | Group B |
Primary outcome
Visual analogue score
Time frame: 12 hours post operative pain will be followed
It is a scale from 0-10 showing minimal pain on 0 and maximum pain on 10. This score is classified in to 5 categories. 0 No Pain 1-3 Mild Pain 4-6 Moderate Pain 7-9 Severe Pain 10 very severe
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2022.
- Individual participant dataSharing planned: No. No plans
Related trials for Pain Relief in Post Operative Patient
Not yet recruiting
ESP Versus SPSIP Block for Pain Relief After Shoulder Arthroscopy
Postoperative Pain
Not yet recruitingPhase 4
Suzetrigine vs. Standard Care Pain Relief Following Outpatient Knee Replacement Surgery
Knee Arthroplasty, Total, Post Operative Pain, Acute
Not yet recruitingPhase 2
A Study on the Efficacy and Safety of Anrikefon for Postoperative Pain Relief Following Laparoscopic Cholecystectomy
Gallbladder Stones, Gallbladder Polyps
Recruiting
Comparison of Pain Relief Methods for Hip Surgery: A Study on Two Different Nerve Block Techniques
Opioid Consumption, Postoperative, Pain, Postoperative
Active, not recruitingPhase 4
Analgesic Effect of Superficial Cervical Plexus Block in Postoperative Neck Surgeries
Postoperative Pain
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing dexmeditomidine and bupivacaine and Bupivacaine in people with Pain Relief in Post Operative Patient, run by Sheikh Zayed Medical College 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 5 inclusion and 4 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 7 Mar 2022. 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 alina zafar, MBBS (+923126555448, docaleena786@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual analogue score (time frame: 12 hours post operative pain will be followed). 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 7 Mar 2022.