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

NCT05097118 | Completed Early Phase 1

• 1 other identifier: Soh-Med-21-10-03
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Appendicitis Acute

Outcome Measures

Primary Outcomes (1)

• Comparison study between Ketamine and Bupivacaine for post operative analgesia

  Analgesia for post -operative Appendectomy operation

  one year

Study Arms (2)

Group of Ketamine injection

EXPERIMENTAL

Ketamine infiltration for post operative analgesia

Drug: Ketamine Versus Bupivacaine

Group of Bupivacaine injection

EXPERIMENTAL

Bupivacaine infiltration for post operative analgesia

Drug: Ketamine Versus Bupivacaine

Interventions

Ketamine Versus Bupivacaine DRUG

Drugs Ketamine versus Bupivacaine

Group of Bupivacaine injection; Group of Ketamine injection

Eligibility Criteria

• Age: 14 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

Sohag University Hospital

Sohag, Egypt

Location

Related Publications (4)

• 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.

  PMID: 22227789 BACKGROUND

• 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.

  PMID: 11460814 BACKGROUND

• 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.

  PMID: 24911371 BACKGROUND

• 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.

  PMID: 17673581 BACKGROUND

MeSH Terms

Conditions

Appendicitis

Condition Hierarchy (Ancestors)

Intraabdominal Infections; Infections; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Cecal Diseases; Intestinal Diseases

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: resident doctor at Anaesthesia and ICU department sohag university hospital

Study Record Dates

• First Submitted: October 17, 2021
• First Posted: October 27, 2021
• Study Start: September 1, 2021
• Primary Completion: May 1, 2022
• Study Completion: May 1, 2022
• Last Updated: October 18, 2022

Record last verified: 2022-10

Locations

EG (1)