Pure Global

comparison of adding dexmedetomidine versus fentanyl to Intrathecal local anesthetic aiming at prevention or lowering the incidence of rebound pain in patients undergoing open surgeries under spinal anesthesia. a Randomized Controlled Trial. - Trial PACTR202310515862483

Access comprehensive clinical trial information for PACTR202310515862483 through Pure Global AI's free database. This Phase 3 trial is sponsored by Mansoura University Hospitals and is currently Completed. The study focuses on Surgery; Anaesthesia.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to Pan Africa Clinical Trials Registry data, helping medical device and pharmaceutical companies navigate clinical research efficiently.

Free Database
Powered by Pure Global AI
840K+ Trials
PACTR202310515862483
Phase 3
Completed
Trial Details
Pan Africa Clinical Trials Registry โ€ข PACTR202310515862483
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
comparison of adding dexmedetomidine versus fentanyl to Intrathecal local anesthetic aiming at prevention or lowering the incidence of rebound pain in patients undergoing open surgeries under spinal anesthesia. a Randomized Controlled Trial.
Dexmedetomidine Versus Fentanyl Added to Intrathecal Local Anesthetic for Prevention of Rebound Pain in Patients Undergoing Open Surgeries Under Spinal Anesthesia.

Study Focus

Surgery; Anaesthesia

Sponsor & Location

Mansoura University Hospitals

Moaaz Mohammed Mohammed ElSaeed

Egypt

Timeline & Enrollment

Phase 3

Sep 01, 2022

Sep 01, 2023

Summary

Spinal anesthesia is a safe and reliable method of anesthesia for abdominal and lower limb surgery, with the advantages of rapid onset of action, economical and easy to administer, and a relatively low side effects rate and shorter post-anesthesia care unit stay. Regional anesthesia (RA) techniques have been shown to reduce perioperative opioid requirements, postoperative length of stay, and positively impact long-term outcomes such as the risk of persistent postsurgical pain (PPSP), morbidity, and mortality. It has been found that many drugs, such as opioids ฮฑ2 adrenergic agonists can be used as adjuvants for intrathecal local anesthetics to improve the quality of spinal anesthesia. Rebound pain is a recently introduced term used to describe acute postoperative pain occurring after regression of the sensory block associated with regional anesthesia. It has been observed to occur after both peripheral nerve block and neuraxial anesthesia. Essential characteristics of rebound pain are that it is acute postoperative pain, ensues following resolution of PNB or neuraxial block, and is clinically significant, either with regard to the intensity of pain or the impact on psychological well-being, quality of recovery, and activities of daily living. This study aims to assess the efficacy of addition of dexmedetomidine versus fentanyl to the local anesthetic for prevention of rebound pain after open surgeries performed under spinal anesthesia. We hypothesize that the intrathecal dexmedetomidine administration would decrease the incidence of rebound pain. Incidence of intraoperative hypotension, bradycardia, nausea, vomiting and pruritus compared between fentanyl and dexmedetomidine groups. Severity of rebound pain score (RPS), duration of the sensory and motor blocks, deepest level of sedation, patient satisfaction from pain control and meperidine requirement all compared between two groups.

ICD-10 Classifications

Other complications of anaesthesia
Anaesthetic, unspecified
During surgical operation
During surgical operation
During surgical operation

Data Source

Pan Africa Clinical Trials Registry

PACTR202310515862483

Non-Device Trial