Post Operative Pain in Total Abdominal HystrectomyPhase 1/2TAP-BvsBK-TAHNCT07482709
Comparison Between Tranversus Abdominis Plane (TAP) Block With Only Bupivacaine and TAP Block With Bupivacaine Plus Ketamine in Reducing Postoperative Pain After Total Abdominal Hystrectomy
A Phase 1/2 study testing bupivicaine 0.25% and bupivicaine 0.25% + ketamine in people with Post Operative Pain in Total Abdominal Hystrectomy, run by Liaquat National Hospital & Medical College at 1 site in Pakistan.
Trial summary
The goal of this study is to know how effectively TAP block can reduce postoperative pain in total abdominal hystrectomy patients when given ketamine in addition to bupivacaine in TAP block and to compare it with the conventional TAP block with bupivacaine only. Read more about this study
- Who is it for?
- Ages 25 to 65 years, women only
- Conditions the study is for
- Post Operative Pain in Total Abdominal Hystrectomy
- What is being tested?
- bupivicaine 0.25% and bupivicaine 0.25% + ketamine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Nov 2025to 1 Apr 2026
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
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 25 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged between 25 to 60 years.
- ASA grade I \& II.
- Undergoing total abdominal hysterectomy.
Who cannot join
- BMI >35kg/m2.
- Patient refusal for participation.
- Patients with coagulation disorders.
- Patents with history of allergy and hypersensitivity to local anesthetic.
- Patient having infection at the injection site.
- Alcohol or drug abuse.
- Cognitive or mental disorder.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
gynae operation theatre at Liaquat National Hospital
Karachi, Sindh, 74800
gynae theatre, (021)111-456-456, admin@lnh.edu.pk
About this study
Official title: Transversus Abdominis Plane Block : A Comparative Study Between Bupivacaine vs Bupivacaine With Ketamine in Total Abdominal Hystrectomy
The goal of this study is to know how effectively TAP block can reduce postoperative pain in total abdominal hystrectomy patients when given ketamine in addition to bupivacaine in TAP block and to compare it with the conventional TAP block with bupivacaine only. The main question it aims to answer is:
Does intervention with ketamine in TAP block lowers the postoperative pain measured via visual analog scale and decreases the need for rescue analgesia?
Patients will be assessed for pain in PACU( post anesthesia care unit), 6 hours, 12 hours and 24 hours postoperatively. Time of rescue analgesia will also be noted if given.
Read the detailed description
This is a prospective, randomized, double blind control trial.Patients will be randomly divided into 2 groups; group A and group B with 15 patients in each group. Group A will recive TAP block with 20ml solution of 0.25% bupivacaine on each side of abdomen while group B will recieve 50mg ketamine in addtion to 20ml of 0.25% bupivacaine.The drugs will be prepared by the second anesthesiologist who will not be part of data collection and analysis.Post operative pain will be assessed using VAS score in PACU, after 6 , 12 and 24hours post total abdominal hystrectomy. Inj. tramadol 50mg will be used as rescue analgesia.In addition to inj. pracetamol 1g 8 hourly and inj. ketorolac 30mg 12 hourly, time for administration of rescue analgesia will be noted.
- Being tested
- bupivicaine 0.25%, bupivicaine 0.25% + ketamine
- Keywords
- post operative pain, total abdominal hystrectomy, TAP Block with ketamine, bupivacaine vs bupivacaine plus ketamine
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bupivicaine 0.25%Drug
20ml of 0.25% bupivacaine inTAP block
bupivicaine 0.25% + ketamineDrug
20ml of 0.25% of bupivacaine with 50mg ketamine in TAP block
| Study group | Role | What they receive |
|---|---|---|
| TAP block with bupivacaine only | Active comparator | Not described Receives: Drug: bupivicaine 0.25% |
| TAP block with bupivacaine plus ketamine | Experimental | Not described Receives: Drug: bupivicaine 0.25% + ketamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS score
VAS (visual analog scale ) score noted VAS of <2 = no pain VAS of 2-4 = mild pain VAS of 5-6 = moderate pain VAS of >6 = severe pain
Measured: At PACU(5 mins after shifting to PACU), 6,12 and 24 hours post-operatively
Time of receiving first rescue analgesia
time for additional requirment of inj. tramadol 50mg for post operative pain relief
Measured: within first 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2026
- Study start1 Nov 2025
- Primary completion15 Mar 2026 (estimated)
- Study completion1 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Operative Pain in Total Abdominal HystrectomyStudies 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 1/2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Liaquat National Hospital & Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Usra Rahim, Liaquat National Hospital & Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07482709
- Sponsor's protocol ID
- URahim
- Acronym
- TAP-BvsBK-TAH
- Status last verified
- Mar 2026
- First submitted
- 5 Mar 2026
- Last updated
- 25 Mar 2026
- 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 25 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transversus Abdominis Plane Block : A Comparative Study Between Bupivacaine vs Bupivacaine With Ketamine in Total Abdominal Hystrectomy
- ClinicalTrials.gov ID
- NCT07482709
- Acronym / sponsor ID
- TAP-BvsBK-TAH / URahim
- Keywords
- post operative pain, total abdominal hystrectomy, TAP Block with ketamine, bupivacaine vs bupivacaine plus ketamine
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Liaquat National Hospital & Medical CollegeUniversity, hospital or other
- Study start
- 1 Nov 2025 (actual)
- Primary completion
- 15 Mar 2026 (estimated)
- Study completion
- 1 Apr 2026 (estimated)
- First posted
- 19 Mar 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.
The goal of this study is to know how effectively TAP block can reduce postoperative pain in total abdominal hystrectomy patients when given ketamine in addition to bupivacaine in TAP block and to compare it with the conventional TAP block with bupivacaine only. The main question it aims to answer is:
Does intervention with ketamine in TAP block lowers the postoperative pain measured via visual analog scale and decreases the need for rescue analgesia?
Patients will be assessed for pain in PACU( post anesthesia care unit), 6 hours, 12 hours and 24 hours postoperatively. Time of rescue analgesia will also be noted if given.
Detailed description
This is a prospective, randomized, double blind control trial.Patients will be randomly divided into 2 groups; group A and group B with 15 patients in each group. Group A will recive TAP block with 20ml solution of 0.25% bupivacaine on each side of abdomen while group B will recieve 50mg ketamine in addtion to 20ml of 0.25% bupivacaine.The drugs will be prepared by the second anesthesiologist who will not be part of data collection and analysis.Post operative pain will be assessed using VAS score in PACU, after 6 , 12 and 24hours post total abdominal hystrectomy. Inj. tramadol 50mg will be used as rescue analgesia.In addition to inj. pracetamol 1g 8 hourly and inj. ketorolac 30mg 12 hourly, time for administration of rescue analgesia will be noted.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TAP block with bupivacaine only | Active comparator | Drug: bupivicaine 0.25% |
| TAP block with bupivacaine plus ketamine | Experimental | Drug: bupivicaine 0.25% + ketamine |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged between 25 to 60 years.
- ASA grade I \& II.
- Undergoing total abdominal hysterectomy.
Key exclusion criteria (7 listed)
- BMI >35kg/m2.
- Patient refusal for participation.
- Patients with coagulation disorders.
- Patents with history of allergy and hypersensitivity to local anesthetic.
- Patient having infection at the injection site.
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 |
|---|---|---|
| bupivicaine 0.25%20ml of 0.25% bupivacaine inTAP block | Drug | TAP block with bupivacaine only |
| bupivicaine 0.25% + ketamine20ml of 0.25% of bupivacaine with 50mg ketamine in TAP block | Drug | TAP block with bupivacaine plus ketamine |
Primary outcome
VAS score
Time frame: At PACU(5 mins after shifting to PACU), 6,12 and 24 hours post-operatively
VAS (visual analog scale ) score noted VAS of <2 = no pain VAS of 2-4 = mild pain VAS of 5-6 = moderate pain VAS of >6 = severe pain
Time of receiving first rescue analgesia
Time frame: within first 24 hours postoperatively
time for additional requirment of inj. tramadol 50mg for post operative pain relief
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2026.
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.
gynae operation theatre at Liaquat National Hospital
Karachi, Pakistan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing bupivicaine 0.25% and bupivicaine 0.25% + ketamine in people with Post Operative Pain in Total Abdominal Hystrectomy, run by Liaquat National Hospital & 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 3 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 25 Mar 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VAS score (time frame: At PACU(5 mins after shifting to PACU), 6,12 and 24 hours post-operatively). The study lists 2 primary outcomes in all. 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 25 Mar 2026.