Rescue AnalgesiaPhase 2TAPNCT06803966
Comparison of Rescue Analgesia Requirement in Patients Undergoing Laparoscopic Cholecystectomy After Transversus Abdominal Plane (tap) Block Vs Local Anesthetic Wound Infiltration At the End of Surgery
A Phase 2 study testing Post Operative Analgesia in people with Rescue Analgesia, run by Fazaia Ruth Pfau Medical College at 1 site in Pakistan.
Trial summary
patients undergoing laparoscopic cholecystectomy will be diveided into 2 groups A \& B . Group A will receive local anesthetic wound infiltration and group B will receive Transversus abdominal plane block as a post operative analgesia. the time for request of first rescue analgesia between the 2 groups will be compared Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Rescue Analgesia
- What is being tested?
- Post Operative Analgesia
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 sitePakistan
- Study dates
- 5 Aug 2024to 11 Jan 2025
- Phase
- Phase 2
- 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
- No healthy volunteers
- Adult
Who may be able to join
- both gender patients undergoing elective laparoscopic cholecystectomy ASA physical status classification 1 \& 2
Who cannot join
- patients with chronic pain patients unable to understand NRS pain scale conversion of laparoscopic to open cholecystectomy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Rescue Analgesia Requirement After Transversus Abdominal Plane (TAP) Block Vs Local Anesthetic Wound Infiltration After Laparoscopic Cholecystectomy
patients undergoing laparoscopic cholecystectomy will be diveided into 2 groups A \& B . Group A will receive local anesthetic wound infiltration and group B will receive Transversus abdominal plane block as a post operative analgesia. the time for request of first rescue analgesia between the 2 groups will be compared
Read the detailed description
After acquiring approval from Institutional Review Board, the work on the study will begin. The patients planned to undergo elective laparoscopic cholecystectomy first appear for pre-anesthesia assessment and here all relevant baseline tests and demographics (age, weight, ASA score, co morbid and allergies) will be recorded. The patient meeting the inclusion criteria will be explained about the study in the language they understand, its benefits, risks and any other relevant queries will be heard and answered. Those willing to participate will be enrolled into the study, after written consent. Confidentiality of the study subjects will be assured throughout. Data will only be accessible to the principal investigator.
Patients will be assigned either in Group A or Group B using sequentially numbered opaque sealed envelope protocol. Both patients and study investigators will be blinded to study groups. Only an anesthetist who will prepare the medication and will not be part of this study, will have correct knowledge of group identification.
On the day of operation, after patient is shifted to the operating room, monitors will be attached and vitals including Blood pressure, heart rate, mean arterial blood pressure, SpO2 and ETCO2 will be continuously monitored. Patient will be pre medicated by 0.1 mg/kg nalbuphine. For induction of anesthesia, 2 mg/kg propofol and 0.5 mg/kg Atracurium as a relaxant will be given. Anesthesia will be maintained on Isoflurane. Before the start of procedure NG tube will be inserted.
At the end of surgery before extubating, Injection ondansetron 0.15 mg/kg IV will be given to the patient. Next, as patients will be divided into two groups via closed envelope method, Group A will get local anesthetic wound infiltration and group B will receive TAP block. Local Anesthetic infiltration will be given with 20ml of 0.5% bupivacaine (5ml at each port site). TAP block will be given as 0.25% bupivacaine 20ml on each side, using ultrasound guidance.
After extubation, patient will be shifted to post surgical ward where they will be kept under close monitoring. Pain status will be monitored using the NRS at following hours 0, 2, 4, 8, 12, 24 and/or when patient complains. Rescue analgesia will be given by injection Toradol as 30 mg IV, when patient categorizes the pain as 4 or more according to NRS. This time at which rescue analgesia is given will be recorded.
- Conditions
- Rescue Analgesia
- Being tested
- Post Operative Analgesia
- Keywords
- transversus abdominal plane block, local anesthetic wound infiltration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Post Operative AnalgesiaOther
Also called Group A : local wound infiltration, Group B : TAP block
Group A will receive local wound infiltration at port sites with inj bupivacaine (bupivacaine Hydrochloride) 0.5 %
Group B will receive Transversus Abdominal Plane Block on both sides by inj bupivacaine (bupivacaine Hydrochloride) 0.25%
| Study group | Role | What they receive |
|---|---|---|
| Group A: local anesthetic infiltration at port sites | Active comparator | Group A patient's will receive local anesthetic wound infiltration at port sites with inj Bupivacaine (Bupivacaine Hydrochloride) 0.5% Receives: Other: Post Operative Analgesia |
| Group B : TAP block | Active comparator | Group b will receive Transversus Abdominal Plane (TAP) block at both sides using inj bupivacaine (Bupivacaine Hydrochloride) 0.25% Receives: Other: Post Operative Analgesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
first rescue analgesia
time of requirement of first rescue analgesia will be compared between group a and group b
Measured: from enrollment to 24 hours post operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2025
- Study start5 Aug 2024
- Primary completion11 Jan 2025
- Study completion11 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rescue 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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- group A will get local ansthetic wound infiltration at port site and Group b will get Transversus abdominal plane block
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fazaia Ruth Pfau Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sumbul Andleeb, Fazaia Ruth Pfau Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06803966
- Sponsor's protocol ID
- FazaiaRuthPfauMC
- Acronym
- TAP
- Status last verified
- Jan 2025
- First submitted
- 22 Jan 2025
- Last updated
- 31 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Rescue Analgesia Requirement After Transversus Abdominal Plane (TAP) Block Vs Local Anesthetic Wound Infiltration After Laparoscopic Cholecystectomy
- ClinicalTrials.gov ID
- NCT06803966
- Acronym / sponsor ID
- TAP / FazaiaRuthPfauMC
- Conditions
- Rescue Analgesia
- Keywords
- transversus abdominal plane block, local anesthetic wound infiltration
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Fazaia Ruth Pfau Medical CollegeUniversity, hospital or other
- Study start
- 5 Aug 2024 (actual)
- Primary completion
- 11 Jan 2025 (actual)
- Study completion
- 11 Jan 2025 (actual)
- First posted
- 31 Jan 2025 (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.
patients undergoing laparoscopic cholecystectomy will be diveided into 2 groups A \& B . Group A will receive local anesthetic wound infiltration and group B will receive Transversus abdominal plane block as a post operative analgesia. the time for request of first rescue analgesia between the 2 groups will be compared
Detailed description
After acquiring approval from Institutional Review Board, the work on the study will begin. The patients planned to undergo elective laparoscopic cholecystectomy first appear for pre-anesthesia assessment and here all relevant baseline tests and demographics (age, weight, ASA score, co morbid and allergies) will be recorded. The patient meeting the inclusion criteria will be explained about the study in the language they understand, its benefits, risks and any other relevant queries will be heard and answered. Those willing to participate will be enrolled into the study, after written consent. Confidentiality of the study subjects will be assured throughout. Data will only be accessible to the principal investigator.
Patients will be assigned either in Group A or Group B using sequentially numbered opaque sealed envelope protocol. Both patients and study investigators will be blinded to study groups. Only an anesthetist who will prepare the medication and will not be part of this study, will have correct knowledge of group identification.
On the day of operation, after patient is shifted to the operating room, monitors will be attached and vitals including Blood pressure, heart rate, mean arterial blood pressure, SpO2 and ETCO2 will be continuously monitored. Patient will be pre medicated by 0.1 mg/kg nalbuphine. For induction of anesthesia, 2 mg/kg propofol and 0.5 mg/kg Atracurium as a relaxant will be given. Anesthesia will be maintained on Isoflurane. Before the start of procedure NG tube will be inserted.
At the end of surgery before extubating, Injection ondansetron 0.15 mg/kg IV will be given to the patient. Next, as patients will be divided into two groups via closed envelope method, Group A will get local anesthetic wound infiltration and group B will receive TAP block. Local Anesthetic infiltration will be given with 20ml of 0.5% bupivacaine (5ml at each port site). TAP block will be given as 0.25% bupivacaine 20ml on each side, using ultrasound guidance.
After extubation, patient will be shifted to post surgical ward where they will be kept under close monitoring. Pain status will be monitored using the NRS at following hours 0, 2, 4, 8, 12, 24 and/or when patient complains. Rescue analgesia will be given by injection Toradol as 30 mg IV, when patient categorizes the pain as 4 or more according to NRS. This time at which rescue analgesia is given will be recorded.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- group A will get local ansthetic wound infiltration at port site and Group b will get Transversus abdominal plane block
| Arm | Type | Receives |
|---|---|---|
| Group A: local anesthetic infiltration at port sites | Active comparator | Other: Post Operative AnalgesiaGroup A patient's will receive local anesthetic wound infiltration at port sites with inj Bupivacaine (Bupivacaine Hydrochloride) 0.5% |
| Group B : TAP block | Active comparator | Other: Post Operative AnalgesiaGroup b will receive Transversus Abdominal Plane (TAP) block at both sides using inj bupivacaine (Bupivacaine Hydrochloride) 0.25% |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- both gender patients undergoing elective laparoscopic cholecystectomy ASA physical status classification 1 \& 2
Key exclusion criteria (1 listed)
- patients with chronic pain patients unable to understand NRS pain scale conversion of laparoscopic to open cholecystectomy
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 |
|---|---|---|
| Post Operative AnalgesiaAlso: Group A : local wound infiltration, Group B : TAP blockGroup A will receive local wound infiltration at port sites with inj bupivacaine (bupivacaine Hydrochloride) 0.5 % Group B will receive Transversus Abdominal Plane Block on both sides by inj bupivacaine (bupivacaine Hydrochloride) 0.25% | Other | Group A: local anesthetic infiltration at port sites, Group B : TAP block |
Primary outcome
first rescue analgesia
Time frame: from enrollment to 24 hours post operation
time of requirement of first rescue analgesia will be compared between group a and group b
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 31 Jan 2025.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Post Operative Analgesia in people with Rescue Analgesia, run by Fazaia Ruth Pfau 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 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: finished, as of the sponsor's last update on 31 Jan 2025. 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?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
first rescue analgesia (time frame: from enrollment to 24 hours post operation). 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 31 Jan 2025.