Efficacy of intrathecal Nalbuphine adjuvant to Bupivacaine comparison with intrathecal Bupivacaine in elective primary unilateral total knee arthroplasty, randomized controlled trial

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

TCTR

Registry ID

TCTR20250108002

Enrollment

124

Registered

2025-01-08

Start date

2024-10-01

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

patients with Osteoarthritis knee underwent to elective primary unilateral Total knee arthroplasty total knee arthroplasty, TKA, intrathecal nalbuphine, ITNB, ITB, Osteoarthritis knee, OA knee

Interventions

Nalbuphine 0.8 mg (Nulphin,Genovate biotechnology co.,Ltd, Taiwan) mixed with 0.5% Bupivacaine 15 mg (AstraZeneca, Bangkok, Thailand) . This solution was used intrathecal injection.,intrathecal 0.5%

Experimental Drug,Active Comparator Drug

Intrathecal nalbuphine adjuvant to bupivacain,Intrathecal bupivacaine

Eligibility

Sex/Gender

All

Age

45 Years to 80 Years

Inclusion criteria

Inclusion criteria: Patients with Osteoarthritis knee underwent to elective primary unilateral total knee arthroplasty 1. Age 18-80 years old 2. ASA physical status I-III

Exclusion criteria

Exclusion criteria: Patient with 1. Contraindication to spinal block anesthesia 2. Allergy to any medications use in research study 3. Inflammatory joint diseases or Chronic pain unrelated to OA 4. Chronic opioid use before surgery (3 months or longer) 5. Preexisting neuropathy involving operative site 6. Major psychological problems 7. History of coronary artery bypass graft surgery 8. History of gastrointestinal ulcer or bleeding 9. Pregnancy or breastfeeding 10. Impaired renal function (Glomerular Filtration Rate (GFR) < 30 mL/min)

Design outcomes

Primary

Measure	Time frame
pain score during rest, knee flexion 600 at 4,8,12,16,20,24,32,40,48 and 72 hours and walking at 24, 48 and 72 hours measured by numeric rating scale (NRS) score	—

Secondary

Measure	Time frame
Cumulative intravenous morphine doses 0-72 hours after surgery 72 hours postoperative Cumulative intravenous morphine doses 0-72 hours after surgery,Duration to the first postoperative morphine requirement 0-72 hours post operative time to first postoperative morphine requirement,Incidence of nausea and vomiting in the first 24 hours postoperative first 24 hours postoperative access nausea /vomiting score,Incidence of pruritis in the first 24 hours postoperative first 24 hours postoperative access pruritis score,Incidence of postoperative respiratory depression first 24 hours postoperative Respiratory rate less than 10 times/mins,Maximum angles of knee flexion 24, 48 and 72 hours postoperative goniomether,Time up and go tests (TUG) 24, 48 and 72 hours postoperative time,Patient satisfaction 24, 48 and 72 hours postoperative Patient reported outcome using a questionnaire interview,Length of hospitalization admission date to discharge date admission date to discharge date	—

Measure

Time frame

Cumulative intravenous morphine doses 0-72 hours after surgery 72 hours postoperative Cumulative intravenous morphine doses 0-72 hours after surgery,Duration to the first postoperative morphine requirement 0-72 hours post operative time to first postoperative morphine requirement,Incidence of nausea and vomiting in the first 24 hours postoperative first 24 hours postoperative access nausea /vomiting score,Incidence of pruritis in the first 24 hours postoperative first 24 hours postoperative access pruritis score,Incidence of postoperative respiratory depression first 24 hours postoperative Respiratory rate less than 10 times/mins,Maximum angles of knee flexion 24, 48 and 72 hours postoperative goniomether,Time up and go tests (TUG) 24, 48 and 72 hours postoperative time,Patient satisfaction 24, 48 and 72 hours postoperative Patient reported outcome using a questionnaire interview,Length of hospitalization admission date to discharge date admission date to discharge date

—

Countries

Thailand

Contacts

Public ContactSaranphat Kowithangkoon

Vajira hospital

saranphat.kow@nmu.ac.th0873900129

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026