Surgical Site Infiltration Using Ketamine Versus Bupivacaine for Analgesia in Post-operative Appendectomy Operation
Sponsor
Sohag University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05097118
Collaborator
(none)
60
1
2
5
11.9
Study Details
Study Description
Brief Summary
surgical site infiltration using ketamine versus Bupivacaine for analgesia in post-operative Appendectomy operation by Ketamine versus Bupivacaine
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Early Phase 1 |
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Surgical Site Infiltration Using Ketamine Versus Bupivacaine for Analgesia in Post-operative Appendectomy Operation
Actual Study Start Date
:
Sep 1, 2021
Anticipated Primary Completion Date
:
Feb 1, 2022
Anticipated Study Completion Date
:
Feb 1, 2022
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Group of Ketamine injection Ketamine infiltration for post operative analgesia |
Drug: Ketamine Versus Bupivacaine
Drugs Ketamine versus Bupivacaine
|
| Experimental: Group of Bupivacaine injection Bupivacaine infiltration for post operative analgesia |
Drug: Ketamine Versus Bupivacaine
Drugs Ketamine versus Bupivacaine
|
Outcome Measures
Primary Outcome Measures
- Comparison study between Ketamine and Bupivacaine for post operative analgesia [one year]
Analgesia for post -operative Appendectomy operation
Eligibility Criteria
Criteria
Ages Eligible for Study:
14 Years
to 50 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Sohag University Hospital | Sohag | Egypt |
Sponsors and Collaborators
- Sohag University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
- 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.
- Kehlet H, Holte K. Effect of postoperative analgesia on surgical outcome. Br J Anaesth. 2001 Jul;87(1):62-72. Review.
Responsible Party:
Gehad Ahmed Aly,
resident doctor at Anaesthesia and ICU department sohag university hospital,
Sohag University
ClinicalTrials.gov Identifier:
NCT05097118
Other Study ID Numbers:
- Soh-Med-21-10-03
First Posted:
Oct 27, 2021
Last Update Posted:
Nov 5, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: