Arthroscopic SurgeryPhase 4NCT07090928
Effectiveness of Per-Operative Bupivicaine in Reducing Postoperative Pain at Port Site and Improving Mobility in Knee Arthoscopic Procedures
A Phase 4 study testing 5 ml of 0.5% bupivacaine infiltrated at each port site in people with Arthroscopic Surgery, run by Khyber Teaching Hospital at 1 site in Pakistan.
Trial summary
The investigator's aim is to evaluate the effectiveness of per-operative bupivacaine infiltration at arthroscopic port sites in reducing post-operative pain compared to placebo in patients undergoing knee arthroscopic procedures. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Arthroscopic Surgery
- What is being tested?
- 5 ml of 0.5% bupivacaine infiltrated at each port site
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 10 Mar 2026to Jun 2026
- Phase
- Phase 4
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Inclusion Criteria Either Male or Female Age range: 18-70 Years Patients scheduled to undergo elective knee arthroscopic procedures Able to understand the VAS pain scale Exclusion Criteria Either Male or Female Age range: 18-70 Years Patients scheduled to undergo elective knee arthroscopic procedures Able to understand the VAS pain scale Known hypersensitivity or allergy to bupivacaine or any local anesthetics Chronic pain conditions requiring regular pain medications History of drug abuse (mainly to opioids) Pregnant women Pre-existing impaired knee mobility No willing to participate in trial
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
Khyber teaching Hospital Peshawer
Peshawar, KPK
Zeeshan Arif, 03475772757, zeeshanarif0061@gmail.com
About this study
The investigator's aim is to evaluate the effectiveness of per-operative bupivacaine infiltration at arthroscopic port sites in reducing post-operative pain compared to placebo in patients undergoing knee arthroscopic procedures.
Read the detailed description
Knee arthroscopy is a minimally invasive surgical procedure widely used to diagnose and treat various knee conditions such as trauma leading to meniscal tears or ligament, patellar dislocations and post-knee arthroplasty complications. Despite its less invasive nature compared to open surgery, patients often experience postoperative pain, particularly at port sites where surgical instruments are introduced which can impair early mobilization and delay recovery, and affect patient satisfaction with the procedure.
Pain management after knee arthroscopy remains a challenge in orthopaedic practice. While various analgesic strategies have been employed, including oral analgesics such as NSAIDs or opioid, intravenous analgesics or intra-articular injections. Yet, the optimal approach in managing port site pain specifically has not been fully established. Port site pain can be troublesome as it may restrict movement and contribute to delayed functional recovery after arthroscopic procedures.
Bupivacaine, a long-acting amide local anesthetic, has been used as postoperative analgesia for many procedures. Its infiltration around surgical incisions has shown promise in reducing pain after different types of surgeries. In knee arthroscopy, bupivacaine has been used intra-articularly with varying reports of its efficacy, but less attention has been given to its specific use for port site pain control and its subsequent impact on early mobility.
Recent studies have demonstrated the potential outcomes of infiltration of local anesthesia at port sites in laparoscopic procedures, suggesting similar techniques could give successful results in arthroscopic knee surgery. The effectiveness of peri-articular infiltration has been documented in total knee arthroplasty, but evidence specifically addressing arthroscopic port sites remains limited. However, a randomized controlled trial, intra-articular levo-bupivacaine demonstrated significantly lower postoperative visual analogue scale (VAS) pain scores of mean 3.2 ± 1.1 compared to bupivacaine mean VAS pain score 4.5 ± 1.3, indicating superior analgesic effect following knee arthroscopy.
This study aims to evaluate the effectiveness of per-operative bupivacaine infiltration at arthroscopic port sites in reducing postoperative pain and improving early mobility following knee arthroscopic procedures. By precisely targeting port site pain, the investigator can postulate that patients will experience greater comfort, require fewer analgesics, and achieve earlier recovery. The findings could provide valuable evidence to establish protocols for port site pain management in knee arthroscopy, potentially improving patient outcomes.
- Conditions
- Arthroscopic Surgery
- Being tested
- 5 ml of 0.5% bupivacaine infiltrated at each port site, Placebo
- Keywords
- Bupivacaine, Postoperative Pain, Port Site Pain, Arthroscopy, Mobility Improvement, Local Anesthetic, Perioperative Analgesia, Minimally Invasive Surgery, Randomized Controlled Trial
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5 ml of 0.5% bupivacaine infiltrated at each port siteDrug
5 ml of 0.5% bupivacaine infiltrated at each port site after the arthroscopic procedures
PlaceboDrug
5ml 0.9%normal saline infiltrated at port site
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | group A (intervention group) will receive 5 ml of 0.5% bupivacaine infiltrated at each port site Receives: Drug: 5 ml of 0.5% bupivacaine infiltrated at each port site |
| Control group | Placebo comparator | Group B (intervention group) will receive 5 ml of 0.9% Normal Saline infiltrated at each port site Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Port Site Pain Score
Pain will be measured using the Visual Analog Scale (VAS) ranging from 0 (no pain) to 10 (worst pain), at the port site following knee arthroscopy.
Measured: 6 hours, 12 hours, and 24 hours postoperatively
Secondary outcomes (1)
Proportion of Patients Achieving Early Mobility
Early mobility is defined as the ability to perform prescribed physical therapy exercises and ambulate (with assistance from a caregiver or ambulatory aids) within 6 hours after knee arthroscopic surgery. This will be recorded as a binary outcome (Yes/No) based on physiotherapist evaluation
Measured: Assessed after 6 hours of completion of procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2025
- Study start10 Mar 2026
- Primary completionJun 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthroscopic SurgeryStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Khyber Teaching Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zeeshan Arif, Khyber Teaching Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07090928
- Sponsor's protocol ID
- 476/DME/KMC
- Status last verified
- Jun 2025
- First submitted
- 4 Jul 2025
- Last updated
- 25 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Per-Operative Bupivicaine in Reducing Postoperative Pain at Port Site and Improving Mobility in Knee Arthoscopic Procedures
- ClinicalTrials.gov ID
- NCT07090928
- Acronym / sponsor ID
- 476/DME/KMC
- Conditions
- Arthroscopic Surgery
- Keywords
- Bupivacaine, Postoperative Pain, Port Site Pain, Arthroscopy, Mobility Improvement, Local Anesthetic, Perioperative Analgesia, Minimally Invasive Surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Khyber Teaching HospitalUniversity, hospital or other
- Study start
- 10 Mar 2026 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 29 Jul 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.
The investigator's aim is to evaluate the effectiveness of per-operative bupivacaine infiltration at arthroscopic port sites in reducing post-operative pain compared to placebo in patients undergoing knee arthroscopic procedures.
Detailed description
Knee arthroscopy is a minimally invasive surgical procedure widely used to diagnose and treat various knee conditions such as trauma leading to meniscal tears or ligament, patellar dislocations and post-knee arthroplasty complications. Despite its less invasive nature compared to open surgery, patients often experience postoperative pain, particularly at port sites where surgical instruments are introduced which can impair early mobilization and delay recovery, and affect patient satisfaction with the procedure.
Pain management after knee arthroscopy remains a challenge in orthopaedic practice. While various analgesic strategies have been employed, including oral analgesics such as NSAIDs or opioid, intravenous analgesics or intra-articular injections. Yet, the optimal approach in managing port site pain specifically has not been fully established. Port site pain can be troublesome as it may restrict movement and contribute to delayed functional recovery after arthroscopic procedures.
Bupivacaine, a long-acting amide local anesthetic, has been used as postoperative analgesia for many procedures. Its infiltration around surgical incisions has shown promise in reducing pain after different types of surgeries. In knee arthroscopy, bupivacaine has been used intra-articularly with varying reports of its efficacy, but less attention has been given to its specific use for port site pain control and its subsequent impact on early mobility.
Recent studies have demonstrated the potential outcomes of infiltration of local anesthesia at port sites in laparoscopic procedures, suggesting similar techniques could give successful results in arthroscopic knee surgery. The effectiveness of peri-articular infiltration has been documented in total knee arthroplasty, but evidence specifically addressing arthroscopic port sites remains limited. However, a randomized controlled trial, intra-articular levo-bupivacaine demonstrated significantly lower postoperative visual analogue scale (VAS) pain scores of mean 3.2 ± 1.1 compared to bupivacaine mean VAS pain score 4.5 ± 1.3, indicating superior analgesic effect following knee arthroscopy.
This study aims to evaluate the effectiveness of per-operative bupivacaine infiltration at arthroscopic port sites in reducing postoperative pain and improving early mobility following knee arthroscopic procedures. By precisely targeting port site pain, the investigator can postulate that patients will experience greater comfort, require fewer analgesics, and achieve earlier recovery. The findings could provide valuable evidence to establish protocols for port site pain management in knee arthroscopy, potentially improving patient outcomes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Drug: 5 ml of 0.5% bupivacaine infiltrated at each port sitegroup A (intervention group) will receive 5 ml of 0.5% bupivacaine infiltrated at each port site |
| Control group | Placebo comparator | Drug: PlaceboGroup B (intervention group) will receive 5 ml of 0.9% Normal Saline infiltrated at each port site |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| 5 ml of 0.5% bupivacaine infiltrated at each port site5 ml of 0.5% bupivacaine infiltrated at each port site after the arthroscopic procedures | Drug | Intervention group |
| Placebo5ml 0.9%normal saline infiltrated at port site | Drug | Control group |
Primary outcome
Postoperative Port Site Pain Score
Time frame: 6 hours, 12 hours, and 24 hours postoperatively
Pain will be measured using the Visual Analog Scale (VAS) ranging from 0 (no pain) to 10 (worst pain), at the port site following knee arthroscopy.
1 secondary outcome
Proportion of Patients Achieving Early Mobility
Time frame: Assessed after 6 hours of completion of procedure
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 Jun 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing 5 ml of 0.5% bupivacaine infiltrated at each port site in people with Arthroscopic Surgery, run by Khyber Teaching Hospital 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?
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 Jun 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. Some participants in this study may receive a placebo. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 Zeeshan Arif (+923475772757, zeeshanarif0061@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Port Site Pain Score (time frame: 6 hours, 12 hours, and 24 hours postoperatively). 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 Jun 2026.