Opioid Free Anesthesia in Prolonged Surgery

March 1, 2022 updated by: Mansoura University

Opioid-Free Anaesthesia During Prolonged Orthotopic Urinary Bladder Diversion Surgery: A Prospective Randomized Comparative Study.

this study is designed to compare intrathecal bolus of bupivacaine-dexmedetomidine versus continuous epidural fentanyl infusion in providing effective operative analgesia, intraoperative hemodynamic stability and less postoperative cumulative opioid induced complications in orthotopic urinary bladder diversion prolonged surgery.

The hypothesis Intrathecal bolus of bupivacaine-dexmedetomidine could replace continuous epidural fentanyl infusion and would be an enough intraoperative analgesic modality with good intraoperative hemodynamic stability and less postoperative complications in orthotopic urinary bladder diversion patients.

Aim of the work The aim of this protocol is to document that intrathecal bolus of bupivacaine-dexmedetomidine analgesia (a low coast analgesic modality) can replace continuous epidural fentanyl infusion analgesic modality with effective operative analgesia, intraoperative hemodynamic stability and less postoperative cumulative opioid induced complications in orthotopic urinary bladder diversion prolonged surgery.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Opioid-free anaesthesia is becoming a popular technique among clinicians. The technique involves administering anaesthesia without any intraoperative systemic, neuraxial or intracavitary opioid It helps in avoiding the opioids during the perioperative period. Opioid-free anaesthesia can be performed along with loco-regional analgesia for better pain control, though it is not always mandatory Spinal bupivacaine-dexmedetomidine can produce intraoperative prolonged continuous analgesia in abdominal surgeries. On the other hand, the stability of continuous epidural fentanyl infusion would produce hemodynamic stability with effective analgesia in orthotopic urinary bladder diversion as an analgesia technique during prolonged abdominal surgery free of nephrotoxic drugs such as NSAIDs. Lipophilic opioids such as fentanyl remain longer within the epidural space by partitioning into epidural fat and thus are found in lower concentrations in cerebrospinal fluid compared with hydrophilic opioids such as morphine. During prolonged infusion of lipophilic opioids such as fentanyl and sufentanyl, the plasma concentration and analgesic effect of these drugs are similar to that of an intravenous infusion .

Titration of epidural local anesthetic and opioid concentrations must be performed to attain a balance between providing optimal analgesia and avoiding hemodynamic instability. The addition of fentanyl does not prolong the sensory and motor block characteristics of dexmedetomidine .

Intrathecal dexmedetomidine is superior to intrathecal magnesium sulfate (MgSO4) during caesarean section with regard to duration of analgesia, pain severity and stress hormone levels. Dexmedetomidine has a rapid onset and longer duration of sensory block compared to MgSO4 .

Paramasivan and his colleagues documented that intrathecal dexmedetomidine has prolonged postoperative analgesic duration, reduced 24 hours pain intensity and reduced the incidence of shivering without an increase in other adverse effects compared to placebo .

Using dexmedetomidine as an adjuvant to bupivacaine for spinal anesthesia in lower limb surgeries has longer duration of sensory and motor block and longer postoperative analgesia .

Mazy and his colleagues documented that intrathecal dexmedetomidine 10 micrograms (mic) and bupivacaine 20 milligram with or without fentanyl 25 mic were suitable for long orthopedic procedures within 6 hours duration. The addition of fentanyl does not prolong the sensory and motor block characteristics of dexmedetomidine. In favor of dexmedetomidine-fentanyl combination was the less hypotension and less sedative requirement .

Epidural fentanyl administered by a continuous infusion can provide an efficient postoperative analgesia and is responsible for a moderate ventilatory depression .

Patel Nagar and his colleagues documented that intrathecal dexmedetomidine of 10 micrograms when compared to lower doses as an adjuvant to hyperbaric bupivacaine significantly prolongs the duration of sensory block, motor block, and analgesia. A disproportionate increase in the duration of analgesia and motor block produces both clinically and statistically significant prolongation of the duration of differential analgesia. Addition of 10 micrograms of intrathecal dexmedetomidine is associated with fewer requirements of postoperative analgesics in patients undergoing lower abdominal and lower limb surgeries without any significant increase in the incidence of side effects .

Study Type

Interventional

Enrollment (Anticipated)

34

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Patients scheduled for orthotopic urinary bladder diversion prolonged surgery procedures.
  2. American society of Anaethesiologists (ASA I-II).
  3. Both sexes.
  4. Age 18 - 70 years.

Exclusion Criteria:

  1. Patient refusal.
  2. Hypersensitivity to amide local anesthetics or opioids as fentanyl.
  3. General contraindications to spinal and epidural anaesthesia as thrombocytopenia, coagulopathy and severe dehydration.
  4. Uncompensated Cardiac or hepatic patients.
  5. Renal failure or respiratory failure patients.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: Epidural Fentanyl group:
Epidural Fentanyl group: using an epidural catheter technique with epidural catheter set, and at L1-2 insertion level directed up to cover up to T6 sensory level, 5ml of bupivacaine 0.5%plus 50 micrograms fentanyl in a total volume of 40 ml added saline 0.9% (epidural injection of bolus of total Volume of 15 ml of 0.0625%bupivacaine with 1.25Mcg/ml fentanyl) then for next G anaesthesia hours to run in a 3-5 ml/h epidural infusion rate.
EXPERIMENTAL: Intrathecal dexmedetomidine group:
Intrathecal dexmedetomidine plus heavy bupivacaine then general A
Drug: INTRATHECAL dexmedetomidine INJECTION
intrathecal bolus of 3ml bupivacaine 0.5% (15mg) plus 10 micrograms dexmedetomidine at 2-3 or 3-4 spinal level.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total postoperative ANALGESIC fentanyl DOSE
Time Frame: first 24 hours in both groups.
Total postoperative intravenous fentanyl requirements in the first twinty four hours after spinal dexmedetomedine
first 24 hours in both groups.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mansoura University

Investigators

  • Study Director: MOHAMED GHANEM, professor, Urology Nephrology center, Faculty of Medicine, Mansoura Univeristy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

March 10, 2022

Primary Completion (ANTICIPATED)

August 10, 2022

Study Completion (ANTICIPATED)

August 15, 2022

Study Registration Dates

First Submitted

February 4, 2022

First Submitted That Met QC Criteria

March 1, 2022

First Posted (ACTUAL)

March 2, 2022

Study Record Updates

Last Update Posted (ACTUAL)

March 2, 2022

Last Update Submitted That Met QC Criteria

March 1, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MS.21.10.1699(date 21/11/2021)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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