Post Operative AnalgesiaPhase 2/3NCT07368075
To Compare Post-op Analgesic Effectiveness of Ropivicaine+Dexamethasone and Ropivacane+Dexmetomidine in TAP Block in Stoma Reversal Under GA in Terms of Duration of Analgesia.
A Phase 2/3 study testing TAP Block with Ropivacaine+Dexamethasone and TAP Block with Ropivacaine+Dexmedetomidine in people with Post Operative Analgesia and Opioid Sparing Anaesthesia, run by Sahiwal medical college sahiwal at 1 site in Pakistan.
Trial summary
Controlling pain is of major concern in intra-operative as well as post-operative period inpatients undergoing all surgeries especially abdominal surgeries.Adequate pain control in post-operative period directly effect patient's recovery and shortens the patient hospital stay consequently decreasing burden on health… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Post Operative Analgesia, Opioid Sparing Anaesthesia, Hypotension, Controlled
- What is being tested?
- TAP Block with Ropivacaine+Dexamethasone and TAP Block with Ropivacaine+Dexmedetomidine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 sitePakistan
- Study dates
- 22 Jul 2024to 15 Jan 2026
- Phase
- Phase 2/3
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age limit: 18-60 years
- Gender of patient i.e., male or female.
- Patients listed for abdominal surgeries
- American Society of Anesthesiologists (ASA) the status of I or II
Who cannot join
- Patients with history of drug allergy.
- Patients with liver disease, kidney disease, cardiac disease or sickle cell anemia,severe preeclampsia CNS disorder on history. Clinical and laboratory assessment
- American Society of Anesthesiologists (ASA status III or IV)
- Patients with morbid obesity 5, Raynaud's disease
- 6. Patients on adrenoceptor agonists or antagonists or narcotics before the operation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison Of Post Operative Analgesic Effectiveness Of Ropivacane Plus Dexamethasone And Ropivacane Plus Dexmedetomidine In Trans Abdominal Plane Block In Stoma Reversal Under General Anesthesia
Controlling pain is of major concern in intra-operative as well as post-operative period inpatients undergoing all surgeries especially abdominal surgeries.Adequate pain control in post-operative period directly effect patient's recovery and shortens the patient hospital stay consequently decreasing burden on health facilities. Inadequate pain control may affect quality of life and increases patient's morbidity and mortality and is a considerable problem worldwide.
Different modalities for pain control are used in post-operative period. Opioids are main stay of treatment in post-operative period but has significant side effect profile like dependence, nausea \& vomiting. Regional blocks like TAP (Trans Abdominal Plane) are now a days being used as post operative analgesia in abdominal surgeries.
The randomized control trial of Comparison of Ropivacane 0.25% plus Dexamethasone and Ropivacane 0.25% plus Dexmedetomedine will be conducted at department of anaesthesia of Sahiwal teaching hospital Sahiwal for 12 months. 86 patients meeting the inclusion criteria will be categorized into two different groups using computer-generated random number table. All patients will undergo a pre-operative assessment on the day before surgery. Both Group will receive TAP block with studied drugs at the end of surgery. After surgery patient will be shifted to post-surgical ward and will be assessed for pain using visual analogue scale (VAS) and data will be collected and analyzed using Statistical Package for the Social Sciences (SPSS) version 26. Quantitative variable will be presented with mean± SD. Comparison of quantitative variable between groups will be done using independent sample-t-test. Comparison of qualitative variable like (opioid sparing effect Nausea,vomiting,Bradycardia,Hypotension) will be presented with frequency and percentages. Data will be stratified on the basis of gender and age. Post-stratification chi-square test will be used to compare both groups for opioid sparing effect in each stratum with p-value≤0.05 as significant
Read the detailed description
After approval from hospital ethical committee and obtaining informed written consent from every patient, patient fulfilling the criteria of inclusion, demographic statics. Patients will be randomly allocated into two groups using a computer-generated random number table. All patients will undergo a per-operative assessment a day before surgery. They will be per-medicated with oral midazolam 0.05 mg/kg 2 h before surgery. Ultrasound machine SonoScape model S11-plus with linear probe with code L741 and frequency range of 5-10 MHz will be used for ultrasound guidance and 25G Quinkes' lumbar puncture needle will be used for administration of dose. Group I patients will receive TAP block with 20 mL 0.25% Rupivacane plus dexamethasone 4 mg at the end of surgery on surgical side. Group II patients will receive 20 mL of 0.25% ropivicaine plus dexmedetomidine 0.25ug/kg body weight at the end of surgery on surgical side. The person who will prepare the study drugs will not participate in the data collection. Anaesthesia will be induced with propofol 2-2.5 mg/kg intravenous (IV) and 0.1mg/kg intravenous (IV). Tracheal intubation will be facilitated by succinylcholine 1.5 mg/kg IV. Anaesthesia will be maintained with isoflurane 0.6 MAC, 60% nitrous oxide, 40% oxygen, atracurium 0.5mg/kg bolus followed by 0.15mg/kg maintenance dose every 30 mints until completion of surgery. Patients Intraoperative monitoring will include electrocardiogram,non-invasive blood pressure at 5 min intervals, oxygen saturation, end-tidal carbon dioxide and nasopharyngeal temperature. Patients will be ventilated by intermittent positive pressure ventilation using a circle system to maintain normocapnia. Heart rate (HR) and mean arterial pressure (MAP) will be maintained within 20% of the pre-operative value. Hypotension (MAP <20% of the baseline or <65 mmHg) will be treated with infusion of normal saline and if required injection phenylephrine boluses IV. Bradycardia (HR <50 beats/min) will be treated with IV atropine 10 µg/kg bolus in both intraoperative and post-operative period. All patients will receive paracetamol 10 mg/kg IV and ondansetron 0.1 mg/kg IV ½ hour before the completion of surgery. At the end of surgery, residual neuromuscular block will be antagonized with 0.04mg/kg of neostigmine and 0.01 mg/kg glycopyrrolate IV. Tracheal extubation will be performed on meeting the standard criteria for extubation. Patients will be shifted to post anaesthesia care unit (PACU) where resident anaesthesia doctor and trained nursing staff 11 unaware of the studied drug given to the patient will assess patients for pain using visual analogue scale (VAS, 0 score correspond to no pain and 10 score to the worst pain).The time will be noted to first request of analgesia (the time interval between the TAP block done at skin closure and the first request to analgesia at vas 4 or more).Postoperative hemodynamic will be assessed every 30mints for first 4 h then 2 hourly for next 24 hr. Inj nalbuphine 0.1mg/kg intravenously will be given on patient required basis as Rescue drug. Total opioid consumption per 24 hours in both groups in term of mg will be noted.
The incidence of postoperative complication of studied drugs will be noted i.e., Bradycardia,hypotension , Nausea and Vomiting for 24 h postoperatively. The data will be collected through structured questionnaire attached as annexure.
- Conditions
- Post Operative Analgesia, Opioid Sparing Anaesthesia, Hypotension, Controlled, Bradycardia, Stoma Reversal Procedure
- Being tested
- TAP Block with Ropivacaine+Dexamethasone, TAP Block with Ropivacaine+Dexmedetomidine
- Medical subject headings
- Hypotension, Bradycardia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAP Block with Ropivacaine+DexamethasoneDrug
With the patient with proper positioning the skin will be disinfected and the transducer positioned. A needle is placed deep to the fascia separating the internal oblique muscle from the transversus abdominis muscle. The needle entry point will be anesthetized with 20 mL 0.25% Rupivacane plus dexamethasone 4 mg. The local anesthetic spreads in this plane, blocking the sensory nerves (like iliohypogastric and ilioinguinal) that run along the abdominal wall.
TAP Block with Ropivacaine+DexmedetomidineDrug
With the patient with proper positioning the skin will be disinfected and the transducer positioned. A needle is placed deep to the fascia separating the internal oblique muscle from the transversus abdominis muscle. The needle entry point will be anesthetized with 20 mL 0.25% Rupivacane plus dexamedetomidine 0.25ug/kg. The local anesthetic spreads in this plane, blocking the sensory nerves (like iliohypogastric and ilioinguinal) that run along the abdominal wall
| Study group | Role | What they receive |
|---|---|---|
| Group Ropivacaine+Dexamethasone | Other | patients will receive TAP block with 20 mL 0.25% Rupivacane+dexamethasone 4 mg Receives: Drug: TAP Block with Ropivacaine+Dexamethasone |
| Group Ropivacaine+Dexmedetomidine | Other | patients will receive TAP Block with 20 mL of 0.25% ropivicaine+dexmedetomidine 0.25ug/kg Receives: Drug: TAP Block with Ropivacaine+Dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post op Analgesia Effectiveness
Duration of Post Op Analgesia
Measured: Up to 24 hours
Secondary outcomes (1)
Opioid sparing Effect
Total opioid consumption in mg/24hrs
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2026
- Study start22 Jul 2024
- Primary completion25 Oct 2025
- Study completion15 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Operative AnalgesiaStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Group I patients will receive TAP block with 20 mL 0.25% Rupivacane plus dexamethasone 4 mg at the end of surgery on surgical side. Group II patients will receive 20 mL of 0.25% ropivacaine plus dexmedetomidine 0.25ug/kg body weight at the end of surgery on surgical side
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sahiwal medical college sahiwal
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Mudassar Ali, Sahiwal medical college sahiwal
- Investigators
- Adeel Riaz, MD, Study director, Sahiwal medical college sahiwal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07368075
- Sponsor's protocol ID
- 213/IRB
- Status last verified
- Jan 2026
- First submitted
- 15 Jan 2026
- Last updated
- 26 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Date will be available on request after completion of study i.e. February 2026
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Of Post Operative Analgesic Effectiveness Of Ropivacane Plus Dexamethasone And Ropivacane Plus Dexmedetomidine In Trans Abdominal Plane Block In Stoma Reversal Under General Anesthesia
- ClinicalTrials.gov ID
- NCT07368075
- Acronym / sponsor ID
- 213/IRB
- Conditions
- Post Operative Analgesia, Opioid Sparing Anaesthesia, Hypotension, Controlled, Bradycardia, Stoma Reversal Procedure
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Sahiwal medical college sahiwalOther government
- Study start
- 22 Jul 2024 (actual)
- Primary completion
- 25 Oct 2025 (actual)
- Study completion
- 15 Jan 2026 (actual)
- First posted
- 26 Jan 2026 (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.
Controlling pain is of major concern in intra-operative as well as post-operative period inpatients undergoing all surgeries especially abdominal surgeries.Adequate pain control in post-operative period directly effect patient's recovery and shortens the patient hospital stay consequently decreasing burden on health facilities. Inadequate pain control may affect quality of life and increases patient's morbidity and mortality and is a considerable problem worldwide.
Different modalities for pain control are used in post-operative period. Opioids are main stay of treatment in post-operative period but has significant side effect profile like dependence, nausea \& vomiting. Regional blocks like TAP (Trans Abdominal Plane) are now a days being used as post operative analgesia in abdominal surgeries.
The randomized control trial of Comparison of Ropivacane 0.25% plus Dexamethasone and Ropivacane 0.25% plus Dexmedetomedine will be conducted at department of anaesthesia of Sahiwal teaching hospital Sahiwal for 12 months. 86 patients meeting the inclusion criteria will be categorized into two different groups using computer-generated random number table. All patients will undergo a pre-operative assessment on the day before surgery. Both Group will receive TAP block with studied drugs at the end of surgery. After surgery patient will be shifted to post-surgical ward and will be assessed for pain using visual analogue scale (VAS) and data will be collected and analyzed using Statistical Package for the Social Sciences (SPSS) version 26. Quantitative variable will be presented with mean± SD. Comparison of quantitative variable between groups will be done using independent sample-t-test. Comparison of qualitative variable like (opioid sparing effect Nausea,vomiting,Bradycardia,Hypotension) will be presented with frequency and percentages. Data will be stratified on the basis of gender and age. Post-stratification chi-square test will be used to compare both groups for opioid sparing effect in each stratum with p-value≤0.05 as significant
Detailed description
After approval from hospital ethical committee and obtaining informed written consent from every patient, patient fulfilling the criteria of inclusion, demographic statics. Patients will be randomly allocated into two groups using a computer-generated random number table. All patients will undergo a per-operative assessment a day before surgery. They will be per-medicated with oral midazolam 0.05 mg/kg 2 h before surgery. Ultrasound machine SonoScape model S11-plus with linear probe with code L741 and frequency range of 5-10 MHz will be used for ultrasound guidance and 25G Quinkes' lumbar puncture needle will be used for administration of dose. Group I patients will receive TAP block with 20 mL 0.25% Rupivacane plus dexamethasone 4 mg at the end of surgery on surgical side. Group II patients will receive 20 mL of 0.25% ropivicaine plus dexmedetomidine 0.25ug/kg body weight at the end of surgery on surgical side. The person who will prepare the study drugs will not participate in the data collection. Anaesthesia will be induced with propofol 2-2.5 mg/kg intravenous (IV) and 0.1mg/kg intravenous (IV). Tracheal intubation will be facilitated by succinylcholine 1.5 mg/kg IV. Anaesthesia will be maintained with isoflurane 0.6 MAC, 60% nitrous oxide, 40% oxygen, atracurium 0.5mg/kg bolus followed by 0.15mg/kg maintenance dose every 30 mints until completion of surgery. Patients Intraoperative monitoring will include electrocardiogram,non-invasive blood pressure at 5 min intervals, oxygen saturation, end-tidal carbon dioxide and nasopharyngeal temperature. Patients will be ventilated by intermittent positive pressure ventilation using a circle system to maintain normocapnia. Heart rate (HR) and mean arterial pressure (MAP) will be maintained within 20% of the pre-operative value. Hypotension (MAP <20% of the baseline or <65 mmHg) will be treated with infusion of normal saline and if required injection phenylephrine boluses IV. Bradycardia (HR <50 beats/min) will be treated with IV atropine 10 µg/kg bolus in both intraoperative and post-operative period. All patients will receive paracetamol 10 mg/kg IV and ondansetron 0.1 mg/kg IV ½ hour before the completion of surgery. At the end of surgery, residual neuromuscular block will be antagonized with 0.04mg/kg of neostigmine and 0.01 mg/kg glycopyrrolate IV. Tracheal extubation will be performed on meeting the standard criteria for extubation. Patients will be shifted to post anaesthesia care unit (PACU) where resident anaesthesia doctor and trained nursing staff 11 unaware of the studied drug given to the patient will assess patients for pain using visual analogue scale (VAS, 0 score correspond to no pain and 10 score to the worst pain).The time will be noted to first request of analgesia (the time interval between the TAP block done at skin closure and the first request to analgesia at vas 4 or more).Postoperative hemodynamic will be assessed every 30mints for first 4 h then 2 hourly for next 24 hr. Inj nalbuphine 0.1mg/kg intravenously will be given on patient required basis as Rescue drug. Total opioid consumption per 24 hours in both groups in term of mg will be noted.
The incidence of postoperative complication of studied drugs will be noted i.e., Bradycardia,hypotension , Nausea and Vomiting for 24 h postoperatively. The data will be collected through structured questionnaire attached as annexure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Group I patients will receive TAP block with 20 mL 0.25% Rupivacane plus dexamethasone 4 mg at the end of surgery on surgical side. Group II patients will receive 20 mL of 0.25% ropivacaine plus dexmedetomidine 0.25ug/kg body weight at the end of surgery on surgical side
| Arm | Type | Receives |
|---|---|---|
| Group Ropivacaine+Dexamethasone | Other | Drug: TAP Block with Ropivacaine+Dexamethasonepatients will receive TAP block with 20 mL 0.25% Rupivacane+dexamethasone 4 mg |
| Group Ropivacaine+Dexmedetomidine | Other | Drug: TAP Block with Ropivacaine+Dexmedetomidinepatients will receive TAP Block with 20 mL of 0.25% ropivicaine+dexmedetomidine 0.25ug/kg |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age limit: 18-60 years
- Gender of patient i.e., male or female.
- Patients listed for abdominal surgeries
- American Society of Anesthesiologists (ASA) the status of I or II
Key exclusion criteria (5 listed)
- Patients with history of drug allergy.
- Patients with liver disease, kidney disease, cardiac disease or sickle cell anemia,severe preeclampsia CNS disorder on history. Clinical and laboratory assessment
- American Society of Anesthesiologists (ASA status III or IV)
- Patients with morbid obesity 5, Raynaud's disease
- 6. Patients on adrenoceptor agonists or antagonists or narcotics before the operation
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 |
|---|---|---|
| TAP Block with Ropivacaine+DexamethasoneWith the patient with proper positioning the skin will be disinfected and the transducer positioned. A needle is placed deep to the fascia separating the internal oblique muscle from the transversus abdominis muscle. The needle entry point will be anesthetized with 20 mL 0.25% Rupivacane plus dexamethasone 4 mg. The local anesthetic spreads in this plane, blocking the sensory nerves (like iliohypogastric and ilioinguinal) that run along the abdominal wall. | Drug | Group Ropivacaine+Dexamethasone |
| TAP Block with Ropivacaine+DexmedetomidineWith the patient with proper positioning the skin will be disinfected and the transducer positioned. A needle is placed deep to the fascia separating the internal oblique muscle from the transversus abdominis muscle. The needle entry point will be anesthetized with 20 mL 0.25% Rupivacane plus dexamedetomidine 0.25ug/kg. The local anesthetic spreads in this plane, blocking the sensory nerves (like iliohypogastric and ilioinguinal) that run along the abdominal wall | Drug | Group Ropivacaine+Dexmedetomidine |
Primary outcome
Post op Analgesia Effectiveness
Time frame: Up to 24 hours
Duration of Post Op Analgesia
1 secondary outcome
Opioid sparing Effect
Time frame: 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 26 Jan 2026.
- Individual participant dataSharing planned: Yes. Date will be available on request after completion of study i.e. February 2026
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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.
Adeel Riaz, MD study director
Sahiwal medical college sahiwal
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing TAP Block with Ropivacaine+Dexamethasone and TAP Block with Ropivacaine+Dexmedetomidine in people with Post Operative Analgesia and Opioid Sparing Anaesthesia, run by Sahiwal medical college sahiwal 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 4 inclusion and 5 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 26 Jan 2026. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Post op Analgesia Effectiveness (time frame: Up to 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 26 Jan 2026.