Analgesic Efficacy of Pre-operative Dose of Ketorolac and Gabapentin

NCT07047040 | Not Yet Recruiting Phase 2

• 1 other identifier: pre-operative analgesia
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

Brief Summary

Evaluation of the analgesic efficacy of a pre-operative dose of ketorolac and gabapentin in reducing post-operative pain scores in patients undergoing TKA

Conditions

Pain, Postoperative; Osteoarthritis, Knee

Keywords

total knee replacement; pre-operative analgesia; ketorolac; gabapentin

Outcome Measures

Primary Outcomes (1)

• evaluate the analgesic efficacy of a pre-operative dose of ketorolac and gabapentin in reducing post-operative pain scores in patients undergoing TKA.

  asses pain postoperatively at 6,12,24 hours using VAS score

  during the first 24 hours post-operatively

Secondary Outcomes (3)

• assess the impact of pre-operative ketorolac and gabapentin on post-operative opioid consumption

  during the first 24 hours post-operatively

• investigate the safety profile of pre-operative ketorolac and gabapentin

  during the first 24 hours post-operatively

• evaluate the effect of pre-operative ketorolac and gabapentin on functional recovery

  during the month after surgery

Study Arms (2)

Experimental group

ACTIVE COMPARATOR

Experimental group will receive single dose of gabapentin 800 mg capsule and ketorolac 30 mg Ampule, one hour prior to administration of spinal anesthesia

Drug: Ketorolac Tromethamine 30 MG/ML Prefilled Syringe; Drug: Gabapentin

control group

PLACEBO COMPARATOR

control group will receive normal saline ampule and empty capsule one hour prior to administration of spinal anesthesia

Drug: Empty Medication Capsules

Interventions

Ketorolac Tromethamine 30 MG/ML Prefilled Syringe DRUG

a pre-operative dose of ketorolac and gabapentin is given to the patients undergoing unilateral TKA one hour prior to surgery, then a post-operative pain scores will be recorded

Experimental group

Gabapentin DRUG

a pre-operative dose of ketorolac and gabapentin is given to the patients undergoing unilateral TKA one hour prior to surgery, then a post-operative pain scores will be recorded

Experimental group

Empty Medication Capsules DRUG

two empty capsules of gabapentin

control group

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients Undergoing Unilateral Total Knee Replacement from 40 years old to 80 years old

You may not qualify if:

• Rheumatoid Arthritis History of Renal impairment Patients refused to be enrolled in the study

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut University, Faculty of Medicine

Asyut, Asyut Governorate, 71515, Egypt

Location

Related Publications (4)

• Skinner HB. Multimodal acute pain management. Am J Orthop (Belle Mead NJ). 2004 May;33(5 Suppl):5-9.

  PMID: 15195936 BACKGROUND

• Capdevila X, Barthelet Y, Biboulet P, Ryckwaert Y, Rubenovitch J, d'Athis F. Effects of perioperative analgesic technique on the surgical outcome and duration of rehabilitation after major knee surgery. Anesthesiology. 1999 Jul;91(1):8-15. doi: 10.1097/00000542-199907000-00006.

  PMID: 10422923 BACKGROUND

• Hebl JR, Dilger JA, Byer DE, Kopp SL, Stevens SR, Pagnano MW, Hanssen AD, Horlocker TT. A pre-emptive multimodal pathway featuring peripheral nerve block improves perioperative outcomes after major orthopedic surgery. Reg Anesth Pain Med. 2008 Nov-Dec;33(6):510-7.

  PMID: 19258965 BACKGROUND

• Lee BH, Park JO, Suk KS, Kim TH, Lee HM, Park MS, Lee SH, Park S, Lee JY, Ko SK, Moon SH. Pre-emptive and multi-modal perioperative pain management may improve quality of life in patients undergoing spinal surgery. Pain Physician. 2013 May-Jun;16(3):E217-26.

  PMID: 23703420 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative; Osteoarthritis, Knee

Interventions

Ketorolac Tromethamine; Gabapentin

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Indomethacin; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Amines; Organic Chemicals; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Hatem Mohamed Bakr, Professor

  Assiut University

  STUDY DIRECTOR

Central Study Contacts

Nour Shaaban Abdel-Aleem, Resident

CONTACT

+00201157257047; Nour.162663325@med.aun.eg

Mohamed Ahmed Mahran, Professor

CONTACT

+00201006134669; drmahran@aun.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident

Model Details: Patients scheduled for unilateral total knee replacement ranging from 40-80 years of age will be selected. Patients will be randomized into two groups. Experimental group will receive single dose of gabapentin 800 mg capsule and ketorolac 30 mg Ampule. While control group will receive normal saline ampule and empty capsule one hour prior to administration of spinal anesthesia. Pain will be assessed postoperatively by visual analogue score at,6 hours, 12 hours and 24 hours. total dose of analgesia in first 24 hours will be recorded. Any complications will be recorded in first 24 hours post- operative period. Follow up: Visual Analog Scale (VAS) will be used at 6, 12, 24 hours post-surgery for assessment of Pain. Any side effects or complications will be recorded. Time Up and Go (TUG) test after 24hrs post-operative. Oxford knee score (OKS) after 4 weeks.

Study Record Dates

• First Submitted: June 24, 2025
• First Posted: July 2, 2025
• Study Start: August 15, 2025
• Primary Completion (Estimated): October 30, 2027
• Study Completion (Estimated): December 30, 2027
• Last Updated: August 1, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)