Value of IPACK Block (Interspace Between the Popliteal Artery and Capsule of Knee) With Spinal Anesthesia Versus Fentanyl Based Spinal Anesthesia for Knee Arthroscopic Meniscectomy

Value of IPACK Block (Interspace Between the Popliteal Artery and Capsule of Knee) With Spinal Anesthesia Versus Fentanyl Based Spinal Anesthesia on Postoperative Analgesia for Knee Arthroscopic Meniscectomy

Postoperative analgesia is provided by local anesthesia combined with intrathecal narcotics. In addition, for the first 24 hours, this combination has a parenteral opioid sparing effect. However, despite its benefits, this method has been associated to an increased incidence of urine retention, nausea, and vomiting, as well as pruritus. A new localized analgesic approach called as IPACK (infiltration between the knee capsule and the popliteal artery) has been employed in practice.

Study Overview

• Status: Completed
• Conditions: Post Operative Pain
• Intervention / Treatment: Procedure: spinal anesthesia using hyperbaric bupivacaine 0.5% (3ml) with fentanyl (25ug)

Detailed Description

The goal of this study was to compare fentanyl based spinal anesthesia to IPACK Block-based spinal anesthesia during knee arthroscopy.

Patients and Methods: The study enrolled sixty patients with ASA (I-II) ranging in age from 25 to 60 years old after receiving ethical committee permission and written informed consent from patients. They were divided into two groups: group F (30 patients) received spinal anesthesia using hyperbaric bupivacaine 0.5% (3ml) with fentanyl (25ug) and group I (30 patients) received spinal anesthesia using hyperbaric bupivacaine 0.5% (3ml) with IPACK Block using plain bupivacaine 0.5% (15ml). Results: In the first 4 hours postoperatively, there were no variations in VAS scores between the two groups; however, following 4 hours and over the next 12 hours, Group I, VAS scores were lower. The amount of morphine used overall was lower in Group I, which took longer than Group F to reach initial rescue analgesia. The level of patient satisfaction 48 hours after surgery was higher in group I than in group F.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Mohamed

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

age from 25 to 60 years old, with ASA physical status I-III undergoing for knee arthroscopy

Exclusion Criteria:

Patient refusal, neuromuscular diseases, allergies to local anesthetics, and contraindications to spinal anesthesia such as coagulopathy and severe mitral stenosis

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: group F; received spinal anesthesia using hyperbaric bupivacaine 0.5% (3ml) with fentanyl (25ug)	Procedure: spinal anesthesia using hyperbaric bupivacaine 0.5% (3ml) with fentanyl (25ug); group I (30 patients) received spinal anesthesia using hyperbaric bupivacaine 0.5% (3ml) with IPACK Block using plain bupivacaine 0.5% (15ml).
Experimental: group I; group I (30 patients) received spinal anesthesia using hyperbaric bupivacaine 0.5% (3ml) with IPACK Block using plain bupivacaine 0.5% (15ml).	Procedure: spinal anesthesia using hyperbaric bupivacaine 0.5% (3ml) with fentanyl (25ug); group I (30 patients) received spinal anesthesia using hyperbaric bupivacaine 0.5% (3ml) with IPACK Block using plain bupivacaine 0.5% (15ml).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
post-operative analgesia	post-operative pain relief	24 hours

Collaborators and Investigators

• Sponsor: Azhar University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2022
• Primary Completion (Actual): February 1, 2022
• Study Completion (Actual): June 1, 2023

Study Registration Dates

• First Submitted: April 5, 2023
• First Submitted That Met QC Criteria: April 18, 2023
• First Posted (Actual): April 27, 2023

Study Record Updates

• Last Update Posted (Actual): July 11, 2023
• Last Update Submitted That Met QC Criteria: July 8, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: IPACK Block, spinal anesthesia, Knee arthroscopy.
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Opioid; Narcotics; Adjuvants, Anesthesia; Anesthetics, Local; Fentanyl; Bupivacaine
• Other Study ID Numbers: 91945931

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No