Postoperative PainPhase 4TKRNCT06187922
Effect of Perioperative Oral Pregabalin in Total Knee Replacement
A Phase 4 study testing Pregabalin 75mg and adductor canal block in people with Postoperative Pain, run by Bahrain Defence Force Hospital at 1 site in Bahrain.
Trial summary
This interventional randomized control trial aim to determine efficacy and safety of Oral pregabalin in improving after surgery pain control in patients undergoing total knee replacement surgeries under regional anesthesia. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Pregabalin 75mg and adductor canal block
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteBahrain
- Study dates
- 1 Sep 2023to 30 Jul 2025
- Phase
- Phase 4
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 to 85 year
- Elective Regional anesthesia.
- Able to follow study protocol
Who cannot join
- ASA -IV
- Age <18 \& > 85 years
- Patients on pregabalin for chronic neuropathic pain.
- Patient under General anesthesia
- Patients with chronic liver failure
- Patients with chronic renal failure on Hemodialysis
- Patients on opioid (>3 month)
- Patient with complicated knee surgery
Trial locations and contacts
1 site in 1 country.
Bahrain1 site, 1 recruiting
- Recruiting
Bahrain Defence Force
Manama, 323
Saleha syed, +97317766666 ext. 7779, public.relations@bdfmedical.org
Ashruf, +97317766666 ext. 6177, ashruf@bdfmedical.org
About this study
Official title: Effect of Perioperative Oral Pregabalin in Total Knee Replacement for Postoperative Pain
This interventional randomized control trial aim to determine efficacy and safety of Oral pregabalin in improving after surgery pain control in patients undergoing total knee replacement surgeries under regional anesthesia. We'll compare the efficacy of pregabalin between two groups, pregabalin group and control group on the basis of their opioid consumption after knee operation.
Read the detailed description
After obtaining approval from the institutional ethical committee and informed written consent, 120 patients fulfilling the inclusion criteria will be included in this study. The patients will be randomly assigned into two equal groups; Group P: Pregabalin group and Group C: control group. Group P will receive oral capsule pregabalin 75mg one hour preoperatively and Group C will not receive any premedication preoperatively.
Intraoperatively both groups will receive inj. Midazolam 2 mg before subarachnoid block with hyperbaric Bupivacaine 0.5% 2.5-3ml and fentanyl 15mcg in the operation theatre (OT). Both groups will also receive parecoxib 40mg IV and paracetamol 1G Intravenous (IV) as part of multimodal analgesia. Both groups will receive dexamethasone 8mg IV prophylactically.
Postoperatively both groups will receive Ultrasound guided Adductor canal saphenous Nerve block in the PACU with 0.2% Bupivacaine 20-30ml \& dexmeditomidine1.0mcg/kg. Group P will receive oral capsule pregabalin 75 mg Q12hourly from the 1st dose for next 60 hours. Group C will not receive any medication. Both groups will receive paracetamol 1G IV Q6Hourly and Rescue Analgesia will be provided with oral oxycodone 5mg TDS and Morphine PCA, in escalating manner as per patient requirement.
for 24 hrs. After 24 hours Both groups with receive tab paracetamol1 g Q4hourly, ibuprofen 400 Q8hourly along with Tab oxycodone as PRN Q8Hourly and PCA morphine.
- Conditions
- Postoperative Pain
- Being tested
- Pregabalin 75mg, adductor canal block
- Keywords
- Total knee replacement, Postoperative pain, Pregabalin, Adductor canal block, Dexmedetomidine
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pregabalin 75mgDrug
Also called capsule
Group pregabalin will receive cap pregabalin 75mg as premedication and will continue as B.D dose for 72 Hrs.
adductor canal blockProcedure or surgery
Also called peripheral nerve block
Both group will receive ultrasound guided Adductor canal block with bupivacaine 0.2% 20-30ml and dexmedetomidine 1mcg/Kg
| Study group | Role | What they receive |
|---|---|---|
| Pregabalin group | Active comparator | this group of patient will receive cap pregabalin 75mg as premedication and will continue as twice daily dose for 72 hrs. Receives: Drug: Pregabalin 75mg; Procedure: adductor canal block |
| Control group | Sham comparator | This group of patient will not receive cap pregabalin but it will receive standard medical care as routine Receives: Procedure: adductor canal block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale Score (0-10)
visual analogue scale score at 4 hours, 8 hours, 12 hours, 24 hours, 36 hours, 48 hours, 60 hours and 72 hours. minimum score mean good outcome
Measured: 72 hours
Secondary outcomes (7)
Richmond Agitation Sedation Scale score {(+4) -0- (-5)}
Richmond Agitation Sedation Scale score at 4 hours, 8 hours, 12 hours, 24 hours, 36 hours, 48 hours, 60 hours and 72 hours. score +/-1 to 0 means good outcome.
Measured: 72 hours
Visual Analogue Sedation score at 1st Continuous Passive Movement
visual analogue score at 1st continuous passive movement
Measured: with in 24 hours
Time of 1st analgesia request
Estimation of time for 1st complaint of pain
Measured: within 24 hours
Incident of bradycardia
Incident of reduction in Heart rate in 1st 24 Hours
Measured: within 24hours
Incident of Hypotension
Incident of reduced blood pressure below baseline
Measured: within 24 hours
Total opioid consumption
Total opioid consumption in 72hours: Oxycodone/Morphine
Measured: within 72 hours
Patient satisfaction
Patient satisfaction at 72 hours: rated as numeric 1-5 (1=not satisfied, 5=fully satisfied)
Measured: within 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2024
- Study start1 Sep 2023
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Postoperative PainStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The patients will be randomly assigned into two equal groups; Group P: Pregablain group and Group C: control group. Group P will receive oral capsule pregabalin 75mg one hour preoperatively and will continue as B.D for 72 hrs, Group C will not receive any premedication preoperatively. Intraoperatively both groups will receive inj. Midazolam 2 mg before subarachnoid block with hyperbaric Bupivacaine 0.5% 2.5-3ml and fentanyl 15mcg in the operation theatre (OT). Both groups will also receive parecoxib 40mg IV and paracetamol 1G Intravenous (IV) as part of multimodal analgesia. Both groups will receive dexamethasone 8mg IV prophylactically. Postoperatively both groups will receive adductor canal block with bupivacaine and dexmedetomidine.
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bahrain Defence Force Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mehtash butt, Bahrain Defence Force Hospital
- Investigators
- Mohammed Al Muharraqi, FRCS,FDSRCS, Study chair, Bahrain Defence Forces Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06187922
- Sponsor's protocol ID
- BDF/R&REC/2023/674
- Other IDs
- BDF/R&REC/2023/674
- Acronym
- TKR
- Status last verified
- Dec 2023
- First submitted
- 5 Dec 2023
- Last updated
- 3 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We're still formulating the extended contact plan to follow patients for chronic pain.
Publications
Li JW, Ma YS, Xiao LK. Postoperative Pain Management in Total Knee Arthroplasty. Orthop Surg. 2019 Oct;11(5):755-761. doi: 10.1111/os.12535.
PubMed 31663286Hah JM, Bateman BT, Ratliff J, Curtin C, Sun E. Chronic Opioid Use After Surgery: Implications for Perioperative Management in the Face of the Opioid Epidemic. Anesth Analg. 2017 Nov;125(5):1733-1740. doi: 10.1213/ANE.0000000000002458.
PubMed 29049117Attal N, Cruccu G, Baron R, Haanpaa M, Hansson P, Jensen TS, Nurmikko T. EFNS guidelines on the pharmacological treatment of neuropathic pain: 2010 revision. Eur J Neurol. 2010 Sep;17(9):1113-e88. doi: 10.1111/j.1468-1331.2010.02999.x. Epub 2010 Apr 9.
PubMed 20402746Ziyaeifard M, Mehrabanian MJ, Faritus SZ, Khazaei Koohpar M, Ferasatkish R, Hosseinnejad H, Mehrabanian M. Premedication with oral pregabalin for the prevention of acute postsurgical pain in coronary artery bypass surgery. Anesth Pain Med. 2015 Jan 17;5(1):e24837. doi: 10.5812/aapm.24837. eCollection 2015 Feb.
PubMed 25830118Chen YK, Boden KA, Schreiber KL. The role of regional anaesthesia and multimodal analgesia in the prevention of chronic postoperative pain: a narrative review. Anaesthesia. 2021 Jan;76 Suppl 1(Suppl 1):8-17. doi: 10.1111/anae.15256.
PubMed 33426669Sun Q, Liu S, Wu H, Ma H, Liu W, Fang M, Liu K, Pan Z. Dexmedetomidine as an Adjuvant to Local Anesthetics in Transversus Abdominis Plane Block: A Systematic Review and Meta-analysis. Clin J Pain. 2019 Apr;35(4):375-384. doi: 10.1097/AJP.0000000000000671.
PubMed 30475260Andersen JH, Jaeger P, Grevstad U, Estrup S, Geisler A, Vilhelmsen F, Dahl JB, Laier GH, Ilfeld BM, Mathiesen O. Systemic dexmedetomidine is not as efficient as perineural dexmedetomidine in prolonging an ulnar nerve block. Reg Anesth Pain Med. 2019 Mar;44(3):333-340. doi: 10.1136/rapm-2018-100089. Epub 2019 Jan 23.
PubMed 30679332
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Perioperative Oral Pregabalin in Total Knee Replacement for Postoperative Pain
- ClinicalTrials.gov ID
- NCT06187922
- Acronym / sponsor ID
- TKR / BDF/R&REC/2023/674
- Conditions
- Postoperative Pain
- Keywords
- Total knee replacement, Postoperative pain, Pregabalin, Adductor canal block, Dexmedetomidine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Bahrain Defence Force HospitalUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Jul 2025 (estimated)
- First posted
- 3 Jan 2024 (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.
This interventional randomized control trial aim to determine efficacy and safety of Oral pregabalin in improving after surgery pain control in patients undergoing total knee replacement surgeries under regional anesthesia. We'll compare the efficacy of pregabalin between two groups, pregabalin group and control group on the basis of their opioid consumption after knee operation.
Detailed description
After obtaining approval from the institutional ethical committee and informed written consent, 120 patients fulfilling the inclusion criteria will be included in this study. The patients will be randomly assigned into two equal groups; Group P: Pregabalin group and Group C: control group. Group P will receive oral capsule pregabalin 75mg one hour preoperatively and Group C will not receive any premedication preoperatively.
Intraoperatively both groups will receive inj. Midazolam 2 mg before subarachnoid block with hyperbaric Bupivacaine 0.5% 2.5-3ml and fentanyl 15mcg in the operation theatre (OT). Both groups will also receive parecoxib 40mg IV and paracetamol 1G Intravenous (IV) as part of multimodal analgesia. Both groups will receive dexamethasone 8mg IV prophylactically.
Postoperatively both groups will receive Ultrasound guided Adductor canal saphenous Nerve block in the PACU with 0.2% Bupivacaine 20-30ml \& dexmeditomidine1.0mcg/kg. Group P will receive oral capsule pregabalin 75 mg Q12hourly from the 1st dose for next 60 hours. Group C will not receive any medication. Both groups will receive paracetamol 1G IV Q6Hourly and Rescue Analgesia will be provided with oral oxycodone 5mg TDS and Morphine PCA, in escalating manner as per patient requirement.
for 24 hrs. After 24 hours Both groups with receive tab paracetamol1 g Q4hourly, ibuprofen 400 Q8hourly along with Tab oxycodone as PRN Q8Hourly and PCA morphine.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The patients will be randomly assigned into two equal groups; Group P: Pregablain group and Group C: control group. Group P will receive oral capsule pregabalin 75mg one hour preoperatively and will continue as B.D for 72 hrs, Group C will not receive any premedication preoperatively. Intraoperatively both groups will receive inj. Midazolam 2 mg before subarachnoid block with hyperbaric Bupivacaine 0.5% 2.5-3ml and fentanyl 15mcg in the operation theatre (OT). Both groups will also receive parecoxib 40mg IV and paracetamol 1G Intravenous (IV) as part of multimodal analgesia. Both groups will receive dexamethasone 8mg IV prophylactically. Postoperatively both groups will receive adductor canal block with bupivacaine and dexmedetomidine.
| Arm | Type | Receives |
|---|---|---|
| Pregabalin group | Active comparator | Drug: Pregabalin 75mg, Procedure: adductor canal blockthis group of patient will receive cap pregabalin 75mg as premedication and will continue as twice daily dose for 72 hrs. |
| Control group | Sham comparator | Procedure: adductor canal blockThis group of patient will not receive cap pregabalin but it will receive standard medical care as routine |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age between 18 to 85 year
- Elective Regional anesthesia.
- Able to follow study protocol
Key exclusion criteria (8 listed)
- ASA -IV
- Age <18 \& > 85 years
- Patients on pregabalin for chronic neuropathic pain.
- Patient under General anesthesia
- Patients with chronic liver failure
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 |
|---|---|---|
| Pregabalin 75mgAlso: capsuleGroup pregabalin will receive cap pregabalin 75mg as premedication and will continue as B.D dose for 72 Hrs. | Drug | Pregabalin group |
| adductor canal blockAlso: peripheral nerve blockBoth group will receive ultrasound guided Adductor canal block with bupivacaine 0.2% 20-30ml and dexmedetomidine 1mcg/Kg | Procedure or surgery | Control group, Pregabalin group |
Primary outcome
Visual Analogue Scale Score (0-10)
Time frame: 72 hours
visual analogue scale score at 4 hours, 8 hours, 12 hours, 24 hours, 36 hours, 48 hours, 60 hours and 72 hours. minimum score mean good outcome
7 secondary outcomes
Richmond Agitation Sedation Scale score {(+4) -0- (-5)}
Time frame: 72 hours
Visual Analogue Sedation score at 1st Continuous Passive Movement
Time frame: with in 24 hours
Time of 1st analgesia request
Time frame: within 24 hours
Incident of bradycardia
Time frame: within 24hours
Incident of Hypotension
Time frame: within 24 hours
Total opioid consumption
Time frame: within 72 hours
Patient satisfaction
Time frame: within 72 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2024.
- Results publication: PubMed 31663286Li JW, Ma YS, Xiao LK. Postoperative Pain Management in Total Knee Arthroplasty. Orthop Surg. 2019 Oct;11(5):755-761. doi: 10.1111/os.12535.
- Results publication: PubMed 29049117Hah JM, Bateman BT, Ratliff J, Curtin C, Sun E. Chronic Opioid Use After Surgery: Implications for Perioperative Management in the Face of the Opioid Epidemic. Anesth Analg. 2017 Nov;125(5):1733-1740. doi: 10.1213/ANE.0000000000002458.
- Results publication: PubMed 20402746Attal N, Cruccu G, Baron R, Haanpaa M, Hansson P, Jensen TS, Nurmikko T. EFNS guidelines on the pharmacological treatment of neuropathic pain: 2010 revision. Eur J Neurol. 2010 Sep;17(9):1113-e88. doi: 10.1111/j.1468-1331.2010.02999.x. Epub 2010 Apr 9.
- Results publication: PubMed 25830118Ziyaeifard M, Mehrabanian MJ, Faritus SZ, Khazaei Koohpar M, Ferasatkish R, Hosseinnejad H, Mehrabanian M. Premedication with oral pregabalin for the prevention of acute postsurgical pain in coronary artery bypass surgery. Anesth Pain Med. 2015 Jan 17;5(1):e24837. doi: 10.5812/aapm.24837. eCollection 2015 Feb.
- Results publication: PubMed 33426669Chen YK, Boden KA, Schreiber KL. The role of regional anaesthesia and multimodal analgesia in the prevention of chronic postoperative pain: a narrative review. Anaesthesia. 2021 Jan;76 Suppl 1(Suppl 1):8-17. doi: 10.1111/anae.15256.
- Results publication: PubMed 30475260Sun Q, Liu S, Wu H, Ma H, Liu W, Fang M, Liu K, Pan Z. Dexmedetomidine as an Adjuvant to Local Anesthetics in Transversus Abdominis Plane Block: A Systematic Review and Meta-analysis. Clin J Pain. 2019 Apr;35(4):375-384. doi: 10.1097/AJP.0000000000000671.
- Results publication: PubMed 30679332Andersen JH, Jaeger P, Grevstad U, Estrup S, Geisler A, Vilhelmsen F, Dahl JB, Laier GH, Ilfeld BM, Mathiesen O. Systemic dexmedetomidine is not as efficient as perineural dexmedetomidine in prolonging an ulnar nerve block. Reg Anesth Pain Med. 2019 Mar;44(3):333-340. doi: 10.1136/rapm-2018-100089. Epub 2019 Jan 23.
- PregabalinLink provided by the sponsor.
- Individual participant dataSharing planned: No. We're still formulating the extended contact plan to follow patients for chronic pain.
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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.
Mohammed Al Muharraqi, FRCS,FDSRCS study chair
Bahrain Defence Forces Hospital
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 Pregabalin 75mg and adductor canal block in people with Postoperative Pain, run by Bahrain Defence Force Hospital at 1 site in Bahrain.
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 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: status not confirmed, as of the sponsor's last update on 3 Jan 2024. 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 Bahrain. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact MEHTASH BUTT, FCPS,FCAI (+97336681277, dr.mehtashbutt@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue Scale Score (0-10) (time frame: 72 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06187922, which also lists 7 linked publications.
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 3 Jan 2024.