Different Bupivacaine Volumes in Infiltration Between Popliteal Artery and Capsule of Knee Block

NCT05438992 | Completed

• 1 other identifier: MD-339-2021
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

Brief Summary

comparing between three different volumes; 15, 20 \& 25 ml of 0.25% bupivacaine to determine the best volume of Infiltration Between Popliteal Artery and Capsule of Knee (IPACK) block following adductor canal block (ACB) with the best analgesia and least complications after total knee arthroplasty (TKA)

Conditions

Pain, Postoperative

Outcome Measures

Primary Outcomes (1)

• visual analogue score ( VAS) for 24 hours postoperatively

  assessment of pain score

  24 hours

Secondary Outcomes (5)

• first rescue analgesia time

  24 hours

• morphine consumption

  24 hours

• sensory block

  24 hours

• morphine complications

  24 hours

• postoperative hemodynamics

  24 hours

Study Arms (3)

group A

ACTIVE COMPARATOR

The patients in this group will be administered 15 ml bupivacaine 0.250 % between the popliteal artery and the capsule of the posterior knee.

Drug: Bupivacaine 0.25% Preservative-Free Injectable Solution

Group B

ACTIVE COMPARATOR

The patients in this group will be administered 20 ml bupivacaine 0.250 % between the popliteal artery and the capsule of the posterior knee.

Drug: Bupivacaine 0.25% Preservative-Free Injectable Solution

Group C

ACTIVE COMPARATOR

The patients in this group will be administered 25 ml bupivacaine 0.250 % between the popliteal artery and the capsule of the posterior knee.

Drug: Bupivacaine 0.25% Preservative-Free Injectable Solution

Interventions

Bupivacaine 0.25% Preservative-Free Injectable Solution DRUG

local anesthetic drug injection for postoperative pain

Group B; Group C; group A

Eligibility Criteria

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

You may qualify if:

• patients undergoing knee arthroscopy surgery.
• Age between 18 years and 65 years.
• Both sexes
• ASA I \& ASA II

You may not qualify if:

• Patients' refusal
• Allergy to any drug that will be used in the study
• Psychological or mental disorders.
• Disturbance of Conscious level.
• Uncooperative patients
• Coagulopathy
• Contraindications to spinal anaesthesia (e.g.: severe mitral stenosis)

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Kasr Alainy hospitals

Cairo, 11562, Egypt

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Heba Omar, MD

  associate professor of anesthesia and surgical ICU, faculty of medicine, Cairo university

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor of Anesthesia, pain management & surgical ICU

Study Record Dates

• First Submitted: June 25, 2022
• First Posted: June 30, 2022
• Study Start: December 15, 2023
• Primary Completion: March 31, 2024
• Study Completion: April 20, 2024
• Last Updated: April 29, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)