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Surgical Site Infiltration Using Ketamine Versus Bupivacaine for Analgesia in Post-operative Appendectomy Operation

Primary Purpose

Appendicitis Acute

Status
Completed
Phase
Early Phase 1
Locations
Egypt
Study Type
Interventional
Intervention
Ketamine Versus Bupivacaine
Sponsored by
Sohag University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Appendicitis Acute

Eligibility Criteria

14 Years - 50 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 60 adult patients with ASA physical physical status class 1 and class 2 undergoing uncomplicated appendectomy under general anesthesia

Exclusion Criteria:

  • Patient refusal
  • drug abuse
  • Patient with neurological, psychiatirc or neuromuscular disease
  • chronic pain on medicine
  • known allergy to the study medicine
  • Infection at the site of infiltration

Sites / Locations

  • Sohag University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Group of Ketamine injection

Group of Bupivacaine injection

Arm Description

Ketamine infiltration for post operative analgesia

Bupivacaine infiltration for post operative analgesia

Outcomes

Primary Outcome Measures

Comparison study between Ketamine and Bupivacaine for post operative analgesia
Analgesia for post -operative Appendectomy operation

Secondary Outcome Measures

Full Information

First Posted
October 17, 2021
Last Updated
October 16, 2022
Sponsor
Sohag University
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1. Study Identification

Unique Protocol Identification Number
NCT05097118
Brief Title
Surgical Site Infiltration Using Ketamine Versus Bupivacaine for Analgesia in Post-operative Appendectomy Operation
Official Title
Surgical Site Infiltration Using Ketamine Versus Bupivacaine for Analgesia in Post-operative Appendectomy Operation
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
September 1, 2021 (Actual)
Primary Completion Date
May 1, 2022 (Actual)
Study Completion Date
May 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sohag University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
surgical site infiltration using ketamine versus Bupivacaine for analgesia in post-operative Appendectomy operation by Ketamine versus Bupivacaine

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Appendicitis Acute

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group of Ketamine injection
Arm Type
Experimental
Arm Description
Ketamine infiltration for post operative analgesia
Arm Title
Group of Bupivacaine injection
Arm Type
Experimental
Arm Description
Bupivacaine infiltration for post operative analgesia
Intervention Type
Drug
Intervention Name(s)
Ketamine Versus Bupivacaine
Intervention Description
Drugs Ketamine versus Bupivacaine
Primary Outcome Measure Information:
Title
Comparison study between Ketamine and Bupivacaine for post operative analgesia
Description
Analgesia for post -operative Appendectomy operation
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 60 adult patients with ASA physical physical status class 1 and class 2 undergoing uncomplicated appendectomy under general anesthesia Exclusion Criteria: Patient refusal drug abuse Patient with neurological, psychiatirc or neuromuscular disease chronic pain on medicine known allergy to the study medicine Infection at the site of infiltration
Facility Information:
Facility Name
Sohag University Hospital
City
Sohag
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
22227789
Citation
American Society of Anesthesiologists Task Force on Acute Pain Management. Practice guidelines for acute pain management in the perioperative setting: an updated report by the American Society of Anesthesiologists Task Force on Acute Pain Management. Anesthesiology. 2012 Feb;116(2):248-73. doi: 10.1097/ALN.0b013e31823c1030. No abstract available.
Results Reference
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PubMed Identifier
11460814
Citation
Kehlet H, Holte K. Effect of postoperative analgesia on surgical outcome. Br J Anaesth. 2001 Jul;87(1):62-72. doi: 10.1093/bja/87.1.62. No abstract available.
Results Reference
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PubMed Identifier
24911371
Citation
Barrington JW, Dalury DF, Emerson RH Jr, Hawkins RJ, Joshi GP, Stulberg BN. Improving patient outcomes through advanced pain management techniques in total hip and knee arthroplasty. Am J Orthop (Belle Mead NJ). 2013 Oct;42(10 Suppl):S1-S20.
Results Reference
background
PubMed Identifier
17673581
Citation
Baker PN, van der Meulen JH, Lewsey J, Gregg PJ; National Joint Registry for England and Wales. The role of pain and function in determining patient satisfaction after total knee replacement. Data from the National Joint Registry for England and Wales. J Bone Joint Surg Br. 2007 Jul;89(7):893-900. doi: 10.1302/0301-620X.89B7.19091.
Results Reference
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Surgical Site Infiltration Using Ketamine Versus Bupivacaine for Analgesia in Post-operative Appendectomy Operation

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