A study to assess the analgesic efficacy of regional block for analgesia with three different doses of local anesthesia

Phase 3

Recruiting

• Conditions: Intraoperative and postprocedural complications and disorders of musculoskeletal system, not elsewhere classified,

• Registration Number: CTRI/2025/05/087318
• Lead Sponsor: Sancheti Institute of Orthopedics and Rehabilitation

Brief Summary

Adequate pain management is crucial for timely discharge of patients after total knee arthroplasty (TKA) surgeries. Regional anaesthesia, particularly peripheral nerve blocks, has become increasingly important in optimizing postoperative pain management and expediting discharge.At present, various techniques can be used to relieve postoperative pain, including [epidural anaesthesia](https://www.sciencedirect.com/topics/medicine-and-dentistry/epidural-anesthesia "Learn more about epidural anesthesia from ScienceDirect’s AI-generated Topic Pages"), [femoral nerve](https://www.sciencedirect.com/topics/medicine-and-dentistry/femoral-nerve "Learn more about femoral nerve from ScienceDirect’s AI-generated Topic Pages") block (FNB), adductor canal block (ACB), and local infiltration analgesia (LIA). A recent network analysis suggests the consideration of a single injection femoral nerve block combined with a sciatic nerve block, or local infiltration analgesia for knee surgeries. [1]

While femoral nerve blocks (FNB) have been associated with less pain and reduced analgesic consumption, there is an increased risk of motor weakness of the quadriceps muscles, and accidental falls as compared to a placebo. [2,3] Besides short-term effects, a decreased quadriceps strength has also been observed six weeks after ACL reconstruction in patients who had received FNB. [4] Recently, ACB has emerged as an alternative to FNB, with the advantage of sparing the motor [nerve supply](https://www.sciencedirect.com/topics/medicine-and-dentistry/innervation "Learn more about nerve supply from ScienceDirect’s AI-generated Topic Pages") to most of the quadriceps muscle and may lead to a reduction in falls after surgery. [5] Several studies have reported similar pain relief and a reduction in the loss of quadriceps motor strength in favor of ACB compared to FNB. [6,7,8] However, other studies have reported more pain after ACB, or similar quadriceps muscle function between both groups. [9,10,11]

Readiness for discharge is an important patient outcome, including various factors such as pain management, associated side effects, mobility, vital parameters, and the presence of any surgical complications such as bleeding [18]. Adductor canal block with higher volume or concentrations may affect quadriceps strength, while higher concentrations may have more analgesic efficacy.[19] Data are limited on comparison of different concentrations of local anaesthetic agents (LA) for adductor canal block (ACB). We hypothesized that 0.5% ropivacaine would provide superior analgesic efficacy to 0.2% ropivacaine. Hence, we plan to compare the impact of two different concentrations of ropivacaine for ACB with regards to its analgesic efficacy and quadriceps muscle strength in patients undergoing total knee arthroplasties.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-02-06
• Last Update Posted: 2025-05-17

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Patients above 18 years or older 2.
• Patients scheduled for elective unilateral total knee arthroplasty 3.
• Patients who are medically fit for regional anesthesia 4.

Exclusion Criteria

• Patients with known allergies to local anesthetics used in the study 2.
• Patients with contraindications to regional anesthesia, such as infection at the site of injection, coagulopathy, or severe peripheral neuropathy 3.
• Patients with pre-existing neurological deficits in the lower extremities 4.
• Patients who are pregnant or breastfeeding 5.
• Patients who are unable to understand the study procedures or cooperate due to cognitive impairment or language barriers 6.
• Patients who refused to give consent.

Study & Design

• Study Type: PMS
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare the quadriceps muscle strength between the two groups.	checked at 1,2,4,8,12 and 24 hour

Secondary Outcome Measures

Name	Time	Method
1.Comparing the NRS at various time points	2. Assessing the opioid requirement post-surgery for each block

Trial Locations

Locations (1)

Sancheti Instituteof Orthopedicsand Rehabiliation; 🇮🇳 South, DELHI, India

Sancheti Instituteof Orthopedicsand Rehabiliation

🇮🇳South, DELHI, India

Sandip Diwan

Principal investigator

9823029328

sdiwan1965@gmx.com