Pain Management Drugs for Postoperative Hip Surgery Pain

No longer recruiting at 1 trial location

Overseen By Patrick Park

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: St. Mary's Research Center, Canada

Must not be taking: Daily opioids

Disqualifiers: Revision surgery, BMI > 45, others

Stay on Your Current Meds You can continue your current medications while participating

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: Immediate post-operative period

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests different methods to manage pain after hip surgery. Researchers compare three techniques: a suprainguinal fascia iliaca compartment block (injecting a painkiller near specific hip nerves), a pericapsular nerve group block (injecting a painkiller between hip muscles), and local anesthetic infiltration (injecting a painkiller into the hip area). The study aims to identify the most effective approach for reducing pain and speeding up recovery after hip replacement surgery due to osteoarthritis. The trial seeks adults needing a first-time hip replacement under spinal anesthesia who have been diagnosed with osteoarthritis. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the chance to be among the first to receive potentially groundbreaking pain management methods.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it excludes patients who are taking daily opioid painkillers before surgery.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Previous studies have shown that bupivacaine hydrochloride, a local anesthetic, is well-tolerated. Both the 0.25% and 0.5% solutions showed no major safety differences, indicating that both strengths are generally safe for humans.

The combination of epinephrine and prilocaine has also undergone testing. Reports found that minor side effects like anxiety or headaches might occur, but these are usually short-lived and not serious.

Ketorolac, a pain reliever, is another treatment under study. It helped with pain after surgery, though there is a small risk of rare bone-related issues.

Since this trial is in the early phase, the main focus is on ensuring the treatments are safe for humans. This step ensures the treatments do not cause unexpected problems. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about this trial because it explores innovative techniques for managing postoperative hip surgery pain. Unlike traditional methods that might rely solely on oral medications like opioids, this trial examines the efficacy of different nerve block techniques. The Suprainguinal fascia iliaca compartment block (FICB) and the Pericapsular nerve group block (PENG) are both designed to target specific nerve groups for more precise pain control. These techniques might offer more effective pain relief with potentially fewer side effects compared to standard care. By comparing these methods to traditional spinal anesthesia, researchers hope to find more efficient ways to manage pain and enhance patient recovery.

What evidence suggests that this trial's treatments could be effective for postoperative hip surgery pain?

Research has shown that bupivacaine, in varying strengths, can effectively manage post-surgical pain. In this trial, participants may receive either a suprainguinal fascia iliaca compartment block (FICB) or a pericapsular nerve group block (PENG) with bupivacaine. Studies have found that both 0.25% and 0.5% bupivacaine effectively ease pain, with no major difference between them. Another treatment arm uses epinephrine with prilocaine, which significantly lowers pain scores and reduces opioid use in the first 24 hours after surgery. Ketorolac, another pain reliever under study, also effectively reduces pain and decreases opioid need post-surgery. This combination of treatments aims to improve recovery by minimizing pain and reducing opioid use. ^{1 2 3 4 6}

Who Is on the Research Team?

Dr. Anthony Albers, MDCM, FRCSC

Principal Investigator

McGill University, Department of Surgery

Are You a Good Fit for This Trial?

This trial is for adults over 18 needing a primary total hip replacement under spinal anesthesia. They must be able to give written consent and understand English or French. It's not for those with a BMI over 45, allergies to the drugs being tested, previous fractures or surgeries on the affected hip, other diagnoses causing significant deformity, or daily opioid use before surgery.

Inclusion Criteria

Written consent

I am an adult needing a hip replacement surgery under spinal anesthesia.

My gender does not limit my participation.

Exclusion Criteria

Patients who do not understand, read or communicate in either French or English

I will receive anesthesia that is not spinal for my procedure.

I have had surgery on my hip before.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive one of the pain control methods (FICB, PENG block, LAI, or spinal anesthesia) following total hip arthroplasty

Immediate post-operative period

1 visit (in-person)

Follow-up

Participants are monitored for pain control effectiveness and side effects, including VAS at 4 hours post-op and patient satisfaction

48 hours

In-hospital monitoring

What Are the Treatments Tested in This Trial?

Interventions

• Bupivacaine Hydrochloride 0.25% Injection Solution_#2
• Bupivacaine Hydrochloride 0.5% Injection Solution_#2
• EPINEPHrine 1:200,000 / Prilocaine HCl 4 % 1.8 ML Cartridge
• Ketorolac

Trial Overview The study tests different pain control methods after hip replacement surgery. It compares local anesthetic infiltration (LAI), nerve blocks (PNBs), NSAIDs like Ketorolac, and other analgesics to see which combination reduces postoperative pain effectively and minimizes narcotic use.

How Is the Trial Designed?

Group I: Suprainguinal fascia iliaca compartment block (FICB) Experimental Treatment 3 Interventions

Suprainguinal fascia iliaca compartment block (FICB) is a technique that involves injection of local anesthetics underneath the fascia of the iliacus muscle to block the femoral nerve, the lateral femoral cutaneous nerve and, possibly, the obturator nerve.

Group II: Pericapsular nerve group block (PENG) Active Control 3 Interventions

The pericapsular nerve group block (PENG) is a technique that involves injection of local anesthetic in the musculofascial plane between the psoas muscle and the superior pubic ramus.

Group III: Local analgesia infiltration (LAI) Placebo Group 3 Interventions

local anesthetic infiltration (LAI) into the anterior pericapsular tissues

Group IV: No adjunct: spinal anaesthesia (control) Placebo Group 2 Interventions

Standard spinal anesthesia technique

Who Is Running the Clinical Trial?

St. Mary's Research Center, Canada

Lead Sponsor

Trials

11

Recruited

1,800+

Published Research Related to This Trial

In a study involving 176 postoperative patients, ketorolac (10 mg orally) provided analgesic efficacy comparable to both 5 mg and 10 mg doses of morphine, significantly outperforming placebo.

Ketorolac is a safe and effective option for managing acute postoperative pain, serving as a non-opioid alternative to traditional opioid therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The use of ketorolac in the management of postoperative pain. DeAndrade, JR., Maslanka, M., Maneatis, T., et al.[2022]

Ketorolac tromethamine is effective for treating moderate to very severe postoperative pain, with oral doses of 10 mg and higher showing significant superiority over placebo and comparable efficacy to morphine.

The drug is well tolerated, with fewer adverse events compared to opioid pain relievers, making it a safer alternative for postoperative pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Analgesic efficacy and safety of single-dose oral and intramuscular ketorolac tromethamine for postoperative pain. Brown, CR., Moodie, JE., Dickie, G., et al.[2013]

A multimodal approach to postoperative pain management, which combines various drugs and techniques, is essential for effective pain relief while minimizing opioid use and their associated side effects.

Local anesthesia, higher doses of paracetamol, and the use of selective COX-2 inhibitors are highlighted as effective alternatives to opioids, with the potential for fewer side effects and improved patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Non-opioid postoperative analgesia. Dahl, V., Raeder, JC.[2022]

Ketorolac tromethamine is an effective nonsteroidal anti-inflammatory drug (NSAID) for managing moderate to severe postoperative pain, reducing the need for opioid analgesics, which can help minimize opioid-related side effects.

Administered intramuscularly, ketorolac reaches peak plasma levels in about 45 to 50 minutes and has a low incidence of side effects, making it a promising option for both inpatient and outpatient pain management, although further research is needed to fully understand its role.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ketorolac: a new parenteral nonsteroidal anti-inflammatory drug for postoperative pain management. Lassen, K., Epstein-Stiles, M., Olsson, GL.[2013]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5564080/

Comparative study of analgesia with bupivacaine 0.25% ... Bupivacaine 0.5% was statistically better for pain control during the immediate postoperative period, but there was no significant difference in pain control.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6726887/

An in vivo study comparing efficacy of 0.25% and 0.5% ... Thus, we concluded that there was no significant difference between 0.25% bupivacaine and 0.5% bupivacaine in terms of onset of action, pain ...

3. wolterskluwer.com wolterskluwer.com/en/news/liposomal-bupivacaine-doesnt-decrease-pain-after-hip-fracture-surgery

Liposomal bupivacaine doesn't decrease pain after hip ... Studies have shown that liposomal bupivacaine can reduce pain after various surgical procedures, including total knee or hip arthroplasty. Few ...

4. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/papr.70048

Efficacy of Liposomal Bupivacaine Versus Standard ... This systematic review and meta-analysis aimed to assess the efficacy of LB versus standard bupivacaine (SB) in improving postoperative outcomes ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S0007091221002208

Procedure-specific acute pain trajectory after elective total ... Acute intense postoperative pain after THA should have resolved by 4–6 h after surgery in most patients. However, there is a substantial gap in knowledge on the ...

6. jss.amegroups.org jss.amegroups.org/article/view/5776/html

Liposomal bupivacaine does not decrease postoperative ... found that local infiltrations of LB with bupivacaine HCl demonstrated a 91% reduction in opioid consumption and 19% decrease in pain intensity ...