Effect of Perioperative Oral Pregabalin in Total Knee Replacement

NCT06187922 | Unknown Phase 4 DMC

• 1 other identifier: BDF/R&REC/2023/674
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Postoperative Pain

Keywords

Total knee replacement; Postoperative pain; Pregabalin; Adductor canal block; Dexmedetomidine

Outcome Measures

Primary Outcomes (1)

• 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

  72 hours

Secondary Outcomes (7)

• Richmond Agitation Sedation Scale score {(+4) -0- (-5)}

  72 hours

• Visual Analogue Sedation score at 1st Continuous Passive Movement

  with in 24 hours

• Time of 1st analgesia request

  within 24 hours

• Incident of bradycardia

  within 24hours

• Incident of Hypotension

  within 24 hours

Study Arms (2)

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.

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

Procedure: adductor canal block

Interventions

Pregabalin 75mg DRUG

Group pregabalin will receive cap pregabalin 75mg as premedication and will continue as B.D dose for 72 Hrs.

Also known as: capsule

Pregabalin group

adductor canal block PROCEDURE

Both group will receive ultrasound guided Adductor canal block with bupivacaine 0.2% 20-30ml and dexmedetomidine 1mcg/Kg

Also known as: peripheral nerve block

Control group; Pregabalin group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 18 to 85 year
• Elective Regional anesthesia.
• Able to follow study protocol

You may not qualify if:

• 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

Sponsors & Collaborators

• Bahrain Defence Force Hospital: lead

Study Sites (1)

Bahrain Defence Force

Manama, 323, Bahrain

RECRUITING

Related Publications (7)

• 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.

  PMID: 31663286 RESULT

• Hah 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.

  PMID: 29049117 RESULT

• Attal 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.

  PMID: 20402746 RESULT

• Ziyaeifard 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.

  PMID: 25830118 RESULT

• Chen 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.

  PMID: 33426669 RESULT

• Sun 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.

  PMID: 30475260 RESULT

• Andersen 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.

  PMID: 30679332 RESULT

Related Links

• Pregabalin

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Pregabalin; Capsules

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Mohammed Al Muharraqi, FRCS,FDSRCS

  Bahrain Defence Forces Hospital

  STUDY CHAIR

Central Study Contacts

MEHTASH BUTT, FCPS,FCAI

CONTACT

+97336681277; dr.mehtashbutt@yahoo.com

Jalal alkhan, MBBch,FRCA

CONTACT

+97317766666; drjalkhan@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief resident

Model Details: 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.

Study Record Dates

• First Submitted: December 5, 2023
• First Posted: January 3, 2024
• Study Start: September 1, 2023
• Primary Completion: June 30, 2025
• Study Completion: July 30, 2025
• Last Updated: January 3, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

BA (1)