Pain Management Drugs for Postoperative Hip Surgery Pain

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

240 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial compares three methods of pain relief after hip replacement surgery in elderly patients with severe arthritis. The methods aim to block pain signals from the hip area, helping patients recover faster and reducing the need for strong painkillers.

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 the treatment generally safe for humans?

Ketorolac, a nonsteroidal anti-inflammatory drug (NSAID), is generally safe for short-term use in managing postoperative pain, with low reported side effects. It can be used as an alternative to opioids, but more research is needed to fully understand its role and side effects. ^{1 2 3 4 5}

How does this drug for postoperative hip surgery pain differ from other treatments?

This drug is unique because it uses a multimodal approach, combining different medications like oral controlled release oxycodone and intravenous paracetamol, to manage pain effectively with fewer side effects compared to traditional opioid-only treatments. ^{6 7 8 9 10}

What data supports the effectiveness of the drug for managing postoperative hip surgery pain?

Research shows that ketorolac tromethamine, a component of the drug, is effective in reducing postoperative pain and morphine consumption in patients after hip replacement surgery. It has been found to be superior to placebo and comparable to morphine in pain relief, with fewer side effects. ^{2 8 11 12 13}

Research Team

Dr. Anthony Albers, MDCM, FRCSC

Principal Investigator

McGill University, Department of Surgery

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Single-shot intraoperative local anaesthetic infiltration does not reduce morphine consumption after total hip arthroplasty: a double-blinded placebo-controlled randomized study. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Intramuscular ketorolac following total hip replacement with spinal anaesthesia and intrathecal morphine. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Analgesic efficacy and safety of single-dose oral and intramuscular ketorolac tromethamine for postoperative pain. [2013]

4. Italy pubmed.ncbi.nlm.nih.gov

[Control of postoperative pain in heart surgery. Comparison of analgesics]. [2014]

5. India pubmed.ncbi.nlm.nih.gov

Chemical stability of tramadol hydrochloride injection admixed with selected pain drugs. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Stability and compatibility of admixtures containing bupivacaine hydrochloride and ketorolac tromethamine for parenteral use. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Ketorolac: a new parenteral nonsteroidal anti-inflammatory drug for postoperative pain management. [2013]

8. United States pubmed.ncbi.nlm.nih.gov

Safety and efficacy of ketorolac tromethamine 0.4% ophthalmic solution in post-photorefractive keratectomy patients. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

The use of ketorolac in the management of postoperative pain. [2022]

10. England pubmed.ncbi.nlm.nih.gov

Characterization of patients undergoing total hip arthroplasty in a real-world setting and pain-related medication prescriptions for management of postoperative pain. [2019]

11. England pubmed.ncbi.nlm.nih.gov

Non-opioid postoperative analgesia. [2022]

12. Italy pubmed.ncbi.nlm.nih.gov

Pain relief after total hip replacement: oral CR oxycodone plus IV paracetamol versus epidural levobupivacaine and sufentanil. A randomized controlled trial. [2018]

13. India pubmed.ncbi.nlm.nih.gov

A study of the usefulness of a periarticular multimodal drug cocktail injection for pain management after total hip arthroplasty. [2021]