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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04322760
Other study ID # 31084/07/16
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 1, 2016
Est. completion date December 1, 2017

Study information

Verified date March 2020
Source Tanta University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Surgery of the knee is a very common procedure which can be very painful and sufficient postoperative pain treatment is often problematic. The aim of this work was to study the effects of supplementation of intra-articular bupivacaine dexmedetomidine with lidocaine 5% patch after arthroscopic knee surgery under general anesthesia and its role in improving quality of anesthesia.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date December 1, 2017
Est. primary completion date November 30, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria:

- Adult patients

- ASA I & II

- Aged between 18 to 60 years

- Weight between 60 to 100 kg

- Scheduled for elective arthroscopic knee surgery

Exclusion Criteria:

- patient refusal.

- history of cardiac disease.

- impaired renal or hepatic function.

- hypertension treated with a methyldopa, clonidine, or beta-adrenergic blockers.

- if they have used opioid analgesics within the previous 24 hr.

- previous sensitivity to local anesthetics.

Study Design


Intervention

Drug:
Lidocaine 5% patch with Dexmedetomidine Bupivacaine
10 ml 0.5 % Bupivacaine and 1µg/kg Dexmedetomidine diluted in 10 ml saline was injected intra-articularly through one of the arthroscopic ports after the end of the surgery under complete aseptic technique and a patch of lidocaine 5% was applied to the skin between the arthroscopic ports
Dexmedetomidine Bupivacaine
10 ml 0.5 % Bupivacaine and 1µg/kg Dexmedetomidine diluted in 10 ml saline was injected intra-articularly through one of the arthroscopic ports after the end of the surgery under complete aseptic technique without a patch of lidocaine 5%

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Tanta University

Outcome

Type Measure Description Time frame Safety issue
Primary The total dose of postoperative pethidine consumption The total dose of postoperative pethidine consumption; Pethidine 20 mg was given as rescue analgesia if pain visual analogue visual analogue scale (VAS) =4. 24 hours
Secondary First postoperative analgesia request time First postoperative analgesia (Pethidine 20 mg) request time 24 hours
Secondary Pain intensity Visual analogue scale (VAS) was recorded immediately postoperative and at 30 min, 1, 2, 4, 6, 12 and 24 hours postoperatively. The score ranges from 0 to 10; higher means worse pain 24 hours
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