The Efficacy of Combined Intrathecal Morphine and PENG Block on Postoperative Pain in Hip Arthroplasty

NCT06298370 | Recruiting DMC

• 1 other identifier: PENG study
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to compare the postoperative 48-hour period in terms of morphine consumption, postoperative pain, and quality of recovery scores by combining the Pericapsular Nerve Group (PENG) block with low-dose intrathecal morphine in hip arthroplasty, as opposed to PENG alone and intrathecal morphine alone.

Conditions

Postoperative Pain Management

Keywords

Postoperative pain; Intrathecal morphine; Intrathecal bupivacaine; Hip arthroplasty; Pericapsular nerve group block

Outcome Measures

Primary Outcomes (1)

• Morphine consumption

  Morphine

  From end of anesthesia (15 minutes after anesthesia) to after 48 hours, up to 48 hours

Secondary Outcomes (2)

• Postoperative pain scores

  From end of anesthesia (15 minutes after anesthesia) to after 48 hours, up to 48 hours

• The quality of recovery score

  From beginning of anesthesia (15 minutes before anesthesia) to after 24 hours, up to 24hours

Study Arms (3)

Group P

ACTIVE COMPARATOR

Patients in this group will undergo ultrasound-guided block using a linear or convex ultrasound probe in the supine position before intrathecal bupivacaine. The block procedure will involve the use of a local anesthetic solution (10-20 ml of 0.25% bupivacaine and 2 mg dexamethasone) and a 22 Gauche 80 mm block needle. Subsequently, intrathecal drug will be administered at the L3-L4 intervertebral level with 10-15 mg of bupivacaine while the patient is in a sitting position.

Drug: Pericapsular nerve group block plus intrathecal bupivacaine

Group M

ACTIVE COMPARATOR

Patients will receive intrathecal bupivacaine plus morphine without Pericapsular Nerve Group block. Intrathecal drugs will be administered at the L3-L4 intervertebral level by adding 10-15 mg bupivacaine with 100 μg of morphine.

Drug: Intrathecal bupivacaine and morphine

Group P+M

ACTIVE COMPARATOR

Patients will undergo ultrasound-guided block using a linear or convex ultrasound probe in the supine position before intrathecal bupivacaine plus morphine. The block procedure will involve the use of a local anesthetic solution (10-20 ml of 0.25% bupivacaine and 2 mg dexamethasone) and a 22 Gauche 80 mm block needle. Intrathecal drugs will be administered at the L3-L4 intervertebral level by adding 10-15 mg bupivacaine with 100 μg of morphine.

Drug: Pericapsular nerve group block plus intrathecal bupivacaine and morphine

Interventions

Pericapsular nerve group block plus intrathecal bupivacaine DRUG

Patients will undergo ultrasound-guided block using a linear or convex ultrasound probe in the supine position before intrathecal bupivacaine. The block procedure will involve the use of a local anesthetic solution (10-20 ml of 0.25% bupivacaine and 2 mg dexamethasone) and a 22 Gauche 80 mm block needle. Subsequently, intrathecal bupivacaine will be administered at the L3-L4 intervertebral level with 10-15 mg bupivacaine while the patient is in a sitting position.The patient controlled analgesia device with morphine will be adjusted as infusion: 0 ml/h, bolus: 1 mg/h, lockout period: 10 min.

Also known as: Spinal anesthesia, Peripheric nerve block

Group P

Intrathecal bupivacaine and morphine DRUG

Patients will receive intrathecal bupivacaine and morphine without Pericapsular Nerve Group block. Intrathecal drugs will be administered at the L3-L4 intervertebral level by adding 10-15 mg bupivacaine with 100 μg of morphine. The patient controlled analgesia device with morphine will be adjusted as infusion: 0 ml/h, bolus: 1 mg/h, lockout period: 10 min.

Also known as: Spinal anesthesia

Group M

Pericapsular nerve group block plus intrathecal bupivacaine and morphine DRUG

Patients will undergo ultrasound-guided block using a linear or convex ultrasound probe in the supine position before intrathecal drugs. The block procedure will involve the use of a local anesthetic solution (10-20 ml of 0.25% bupivacaine and 2 mg dexamethasone) and a S22 Gauche 80 mm block needle. Subarachnoid block will be administered at the L3-L4 intervertebral level by adding 10-15 mg bupivacaine with 100 μg of morphine. The patient controlled analgesia device with morphine will be adjusted as infusion: 0 ml/h, bolus: 1 mg/h, lockout period: 10 min.

Also known as: Spinal anesthesia, Peripheric nerve block

Group P+M

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged between 18 and 90 years
• American Society of Anesthesiologists (score ranging from 1 to 4)
• Anterior hip arthroplasties

You may not qualify if:

• Patients with a history of opioid addiction
• Individuals under the age of 18
• Those aged 90 and above
• Allergies to morphine, fentanyl, bupivacaine, or tramadol
• Coagulopathy
• Infection at the injection site
• Severe cardiac, renal, or hepatic dysfunction
• Cases unable to provide informed consent
• Body Mass Index \>40 kg/m2
• Known neurological or anatomical deficits in the lower extremities
• Patients requiring a transition from spinal anesthesia to general anesthesia

Sponsors & Collaborators

• Bezmialem Vakif University: lead

Study Sites (1)

Bezmialem Vakif University

Istanbul, Fatih, 34093, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Anesthesia, Spinal; Morphine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Saadet Oztop, MD

  Bezmialem Vakif University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Saadet MD Oztop, MD

CONTACT

+905067861993; soztop@bezmialem.edu.tr

Ayhan Dalak

CONTACT

+905301730123; adalak@bezmialem.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: prospective, double-blind, randomized clinical trial

Study Record Dates

• First Submitted: February 3, 2024
• First Posted: March 7, 2024
• Study Start: March 18, 2024
• Primary Completion: June 8, 2024
• Study Completion: July 8, 2024
• Last Updated: March 7, 2024

Record last verified: 2024-03

Locations

TU (1)