AppendectomyPhase 1NCT07429448
Comparison Of Clinical Outcomes of Intraperitoneal Bupivacaine Instillation Versus Placebo as Preemptive Analgesia in Patients Undergoing Open Appendectomy
A Phase 1 study testing Bupivacain and Normal Saline in people with Appendectomy, run by Sardar Umer Rehman at 1 site in Pakistan.
Trial summary
To compare the clinical outcomes of intraperitoneal bupivacaine instillation vs placebo as preemptive analgesia in patients undergoing open appendectomy Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Appendectomy
- What is being tested?
- Bupivacain and Normal Saline
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 16 Dec 2025to 16 Jun 2026
- Phase
- Phase 1
- 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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients presenting to the emergency department undergoing open appendectomy.
Who cannot join
- Patients undergoing interval appendectomy or having perforated appendix as evident by examination (abdominal tenderness/ fever) and USG findings (presence of abscess, fluid collection, or free air).
- Uncontrolled medical disease (DM: BSL >200mg/dl, HTN: BP >140/90)
- History of chronic kidney or liver disease/ psychiatric illness/ Active peptic ulcer disease (as determined on history and medical records)
- Alcoholics
- History of chronic pain or patients on analgesic medications
- Pregnant females
- History of allergy to bupivacaine/ ketorolac as determined on history
- Children, Adolescents and patients with mental illness.
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
Services Institute of Medical Sciences/ Services Hospital Lahore
Lahore, Punjab Province, 54000
Prof Javaid Ur Rehman Ashraf, MBBS, FCPS, +923334233682, javaid.rehman@yahoo.com
About this study
To compare the clinical outcomes of intraperitoneal bupivacaine instillation vs placebo as preemptive analgesia in patients undergoing open appendectomy
- Conditions
- Appendectomy
- Being tested
- Bupivacain, Normal Saline
- Keywords
- Analgesia, Bupivacaine, Open Appendectomy
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BupivacainDrug
Bupivacaine with 0.25% of concentration at the end of the operation intraperitoneally.
Normal SalineOther
10ml of Normal Saline at the end of the operation intraperitoneally.
| Study group | Role | What they receive |
|---|---|---|
| Group A participants who will receive Bupivacaine Intraperitoneally | Experimental | This group consists of 30 participants and will receive Bupivacaine with 0.25% of concentration intraperitoneally during open appendectomy. Surgery duration will be noted. Analgesic consumption will also be recorded at 2, 6, 12 and 24 hours postoperatively. 1st Rescue analgesia will be given in the form of injection Ketorolac at a dose of 0.5mg/kg whenever the patient reported visual analogue score greater and equal to 4. However, if 1st rescue analgesia fails injection Nalbuphine with dose of 0.1mg/kg per dose will be used as 2nd rescue analgesia. Injection paracetamol 1g IV TDS will be given to all patients considered to be sufficient 1st line analgesia. Patients will be discharged 2 days after surgery when diet and pain will be tolerated. If pain persisted at the time of discharge, oral analgesics will be given for 3 or 4 days. Post operative follow up will be done according to protocol. All information will be recorded on a preformed proforma. Receives: Drug: Bupivacain |
| Group B participants who will receive 10 ml of normal saline Intraperitoneally | Active comparator | This group consists of 30 participants and will receive 10 ml of Normal Saline intraperitoneally during open appendectomy. Surgery duration will be noted. Analgesic consumption will also be recorded at 2, 6, 12 and 24 hours postoperatively. 1st Rescue analgesia will be given in the form of injection Ketorolac at a dose of 0.5mg/kg whenever the patient reported visual analogue score greater and equal to 4. However, if 1st rescue analgesia fails injection Nalbuphine with dose of 0.1mg/kg per dose will be used as 2nd rescue analgesia. Injection paracetamol 1g IV TDS will be given to all patients considered to be sufficient 1st line analgesia. Patients will be discharged 2 days after surgery when diet and pain will be tolerated. If pain persisted at the time of discharge, oral analgesics will be given for 3 or 4 days. Post operative follow up will be done according to protocol. All information will be recorded on a preformed proforma. Receives: Other: Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post operative pain
Intensity of post operative pain by using visual analogue score and frequency of postoperative rescue analgesics if required after instillation of bupivacaine and placebo in both groups. Both outcomes will be noted at different intervals i.e. 2, 6, 12 and 24 hours postoperatively for comparison as mentioned.
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 posted24 Feb 2026
- Study start16 Dec 2025
- Primary completion16 Jun 2026 (estimated)
- Study completion16 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AppendectomyStudies 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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sardar Umer Rehman
- Sponsor type
- Other government
- Collaborators
- Services Institute of Medical Sciences, Pakistan
- Responsible party
- Sponsor-investigator, Sardar Umer Rehman, Services Institute of Medical Sciences, Pakistan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07429448
- Sponsor's protocol ID
- 14
- Status last verified
- Feb 2026
- First submitted
- 17 Feb 2026
- Last updated
- 24 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Of Clinical Outcomes of Intraperitoneal Bupivacaine Instillation Versus Placebo as Preemptive Analgesia in Patients Undergoing Open Appendectomy
- ClinicalTrials.gov ID
- NCT07429448
- Acronym / sponsor ID
- 14
- Conditions
- Appendectomy
- Keywords
- Analgesia, Bupivacaine, Open Appendectomy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Sardar Umer RehmanOther government
- Collaborators
- Services Institute of Medical Sciences, Pakistan
- Study start
- 16 Dec 2025 (actual)
- Primary completion
- 16 Jun 2026 (estimated)
- Study completion
- 16 Jun 2026 (estimated)
- First posted
- 24 Feb 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.
To compare the clinical outcomes of intraperitoneal bupivacaine instillation vs placebo as preemptive analgesia in patients undergoing open appendectomy
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A participants who will receive Bupivacaine Intraperitoneally | Experimental | Drug: BupivacainThis group consists of 30 participants and will receive Bupivacaine with 0.25% of concentration intraperitoneally during open appendectomy. Surgery duration will be noted. Analgesic consumption will also be recorded at 2, 6, 12 and 24 hours postoperatively. 1st Rescue analgesia will be given in the form of injection Ketorolac at a dose of 0.5mg/kg whenever the patient reported visual analogue score greater and equal to 4. However, if 1st rescue analgesia fails injection Nalbuphine with dose of 0.1mg/kg per dose will be used as 2nd rescue analgesia. Injection paracetamol 1g IV TDS will be given to all patients considered to be sufficient 1st line analgesia. Patients will be discharged 2 days after surgery when diet and pain will be tolerated. If pain persisted at the time of discharge, oral analgesics will be given for 3 or 4 days. Post operative follow up will be done according to protocol. All information will be recorded on a preformed proforma. |
| Group B participants who will receive 10 ml of normal saline Intraperitoneally | Active comparator | Other: Normal SalineThis group consists of 30 participants and will receive 10 ml of Normal Saline intraperitoneally during open appendectomy. Surgery duration will be noted. Analgesic consumption will also be recorded at 2, 6, 12 and 24 hours postoperatively. 1st Rescue analgesia will be given in the form of injection Ketorolac at a dose of 0.5mg/kg whenever the patient reported visual analogue score greater and equal to 4. However, if 1st rescue analgesia fails injection Nalbuphine with dose of 0.1mg/kg per dose will be used as 2nd rescue analgesia. Injection paracetamol 1g IV TDS will be given to all patients considered to be sufficient 1st line analgesia. Patients will be discharged 2 days after surgery when diet and pain will be tolerated. If pain persisted at the time of discharge, oral analgesics will be given for 3 or 4 days. Post operative follow up will be done according to protocol. All information will be recorded on a preformed proforma. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients presenting to the emergency department undergoing open appendectomy.
Key exclusion criteria (8 listed)
- Patients undergoing interval appendectomy or having perforated appendix as evident by examination (abdominal tenderness/ fever) and USG findings (presence of abscess, fluid collection, or free air).
- Uncontrolled medical disease (DM: BSL >200mg/dl, HTN: BP >140/90)
- History of chronic kidney or liver disease/ psychiatric illness/ Active peptic ulcer disease (as determined on history and medical records)
- Alcoholics
- History of chronic pain or patients on analgesic 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 |
|---|---|---|
| BupivacainBupivacaine with 0.25% of concentration at the end of the operation intraperitoneally. | Drug | Group A participants who will receive Bupivacaine Intraperitoneally |
| Normal Saline10ml of Normal Saline at the end of the operation intraperitoneally. | Other | Group B participants who will receive 10 ml of normal saline Intraperitoneally |
Primary outcome
Post operative pain
Time frame: 24 hours
Intensity of post operative pain by using visual analogue score and frequency of postoperative rescue analgesics if required after instillation of bupivacaine and placebo in both groups. Both outcomes will be noted at different intervals i.e. 2, 6, 12 and 24 hours postoperatively for comparison as mentioned.
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 24 Feb 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Bupivacain and Normal Saline in people with Appendectomy, run by Sardar Umer Rehman 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 8 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 24 Feb 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 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.
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?
Contact Dr Sardar Umar Rehman, MBBS (+923319326657, umersardar578@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post operative pain (time frame: 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 24 Feb 2026.