Analgesic Effect of Adductor Canal Block With and Without Dexamethasone for Knee Arthroscopy

August 3, 2017 updated by: Mohamed galal aly, Assiut University

The Effect of Adding Dexamethasone to Bupivacaine in Ultrasound Guided Adductor Canal Block for Postoperative Analgesia Following Knee Arthroscopic Anterior Cruciate Ligament Reconstruction

The purpose of this study was to evaluate the efficacy of ultra-sound guided adductor canal block with and without dexamethasone when added to bupivacaine on the duration of postoperative analgesia in patients undergoing arthroscopic anterior cruciate ligament reconstruction surgery using Numeric Rating Score (NRS).

Study Overview

Status

Completed

Detailed Description

Adductor canal block was done by Ultra-sound. After confirmation of the block and exclusion of any signs of toxicity or nerve injury, the patients operations were done under spinal anesthesia. Patients were allocated into one of 2 groups (30 patients per group).

I. Group I: the patients received a single-shot of 20 ml plain bupivacaine (0.5%) +2 ml normal saline.

ii.Group II: the patients received 20ml plain bupivacaine (0.5%) + 8 mg dexamethasone (2ml).

Postoperative pain were assessed by Numeric Rating Scale (N.R.S) every 6 h post-operatively for 24 h.

Whenever, the NRS Score was ≥4 or the patient requested pain medication, analgesia was provided by ketorolac 30 mg amp IV, then morphine 1mg ̸ kg slowly IV as a rescue analgesia. Time to first request for analgesia & total dose of rescue analgesia were be recorded.

10. Satisfaction score will be measured on a linear numerical scale; ranging from 0 = complete dissatisfaction to 10 = complete satisfaction. Any post-operative side effects, like nausea, vomiting, bradycardia, hypotension will be also documented. The time to first analgesic requirement will be recorded, and the cumulative, post-operative opioid consumption in 24 h post-operatively will be recorded. Assessment of Quadriceps Strength at preoperative, 6, 12, 18, and 24 h postoperative from zero to 5.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adult ASA I-II Arthroscopic anterior cruciate ligament reconstruction

Exclusion Criteria:

  • patient refusal
  • drug allergy
  • failed procedure

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: group I
Group I (MS): received single shot 20 ml 0.5% isobaric bupivacaine + 2.0 ml normal saline solution injected into the adductor canal preoperatively.
Injected in the adductor canal
Other Names:
  • Normal Saline Solution
Active Comparator: group II
Group II (MD): received 20 ml 0.5% isobaric bupivacaine + 8.0 mg dexamethasone (2.0 ml) injected into adductor canal preoperatively.
Injected in the adductor canal
Other Names:
  • Decadron

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
duration of postoperative analgesia
Time Frame: One day postoperative
assessed by pain score
One day postoperative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
postoperative analgesic consumption
Time Frame: One day postoperative
postoperative opioid consumption
One day postoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2016

Primary Completion (Actual)

June 1, 2017

Study Completion (Actual)

July 22, 2017

Study Registration Dates

First Submitted

July 24, 2017

First Submitted That Met QC Criteria

August 3, 2017

First Posted (Actual)

August 4, 2017

Study Record Updates

Last Update Posted (Actual)

August 4, 2017

Last Update Submitted That Met QC Criteria

August 3, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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