Comparative Study Between Two Adjuvant Drugs to Bupivacaine for Post-operative Epidural Analgesia in Abdominal Surgeries

Epidural Analgesia Clinical Trial

Official title:

Comparative Study Between Dexmedetomidine and Fentanyl as Adjuvants to Bupivacaine for Post-operative Epidural Analgesia in Abdominal Surgeries

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05323214
• Other study ID #: FMASU MD 121/2021
• Status: Recruiting
• Phase: Phase 4
• Start date: August 1, 2021
• Est. completion date: September 30, 2022

Study information

• Verified date: July 2022
• Source: Ain Shams University
• Contact: Ibrahim A Ibrahim, MD
• Phone: +201208208230
• Email: Drhema2010n[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Epidural analgesia is associated with early postoperative mobilization and rehabilitation with minimally associated pain and discomfort. Analgesic effect of local anesthetics is augmented by addition of adjuvants in epidural anesthesia ensuring satisfactory postoperative period. This study evaluates the effect of dexmedetomidine and fentanyl as additives to bupivacaine for epidural analgesia.

Description:

The aim of the study is to evaluate the effect of dexmedetomidin and fentanyl as adjuvants to bupivacaine for postoperative epidural analgesia in abdominal surgeries regarding block characteristics, post-operative analgesia, hemodynamic changes and any anticipated side effects.

• Type of Study: Prospective randomized comparative clinical study.

• Study Setting: The operating theatres of Ain Shams University Hospitals

• Study Period: One year

• Sampling Method: Random sampling Patients randomly allocated by computer generated randomization and using opaque sealed envelopes to one of the three study groups according to the adjuvant drug used in postoperative analgesia.

• Sample Size: Total 75 cases divided into 25 cases in each group. Kiran et al. (2018) reported a rather large effect size comparing onset to sensory block and time to maximum motor block. In a one-way ANOVA study, sample sizes of 25 cases per group in three groups whose means are to be compared. The total sample of 75 subjects achieves 80% power to detect differences among the means versus the alternative of equal means using an F test with a 0.0500 significance level. The size of the variation in the means is represented by the effect size = 0.4

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: September 30, 2022
• Est. primary completion date: August 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 70 Years

Eligibility

Inclusion Criteria:

• ASA I or ASA II patients.

• Age group: 21-70 years old.

• BMI =40

• Duration of procedure = 180 minutes.

Exclusion Criteria:

• Patients with known neurologic and psychiatric illness will be excluded from the study.

• Contraindications for epidural anesthesia as patient refusal, bleeding or coagulation test abnormalities, local skin infection at spinal lumbar region, raised intracranial pressure and hypovolemia

• Spine abnormalities.

• Systemic disorders like hematological, respiratory, cardiac, renal or hepatic insufficiency.

• Allergy to any of the drugs used in the study.

Related Conditions & MeSH terms

• Epidural Analgesia

Intervention

Drug:
• Control Analgesic regimen
testing the efficiency of bupivacaine without adjuvant drugs in epidural analgesia
• Fentanyl Analgesic regimen
testing the efficiency of Fentanyl as an adjuvant drug to bupivacaine in epidural analgesia
• Dexmedetomidine Analgesic regimen
testing the efficiency of Dexmedetomidine as an adjuvant drug to bupivacaine in epidural analgesia

Locations

Country	Name	City	State
Egypt	Ain Shams University Hospitals	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

References & Publications (7)

Grewal A. Dexmedetomidine: New avenues. J Anaesthesiol Clin Pharmacol. 2011 Jul;27(3):297-302. doi: 10.4103/0970-9185.83670. — View Citation

Hetta DF, Fares KM, Abedalmohsen AM, Abdel-Wahab AH, Elfadl GMA, Ali WN. Epidural dexmedetomidine infusion for perioperative analgesia in patients undergoing abdominal cancer surgery: randomized trial. J Pain Res. 2018 Oct 30;11:2675-2685. doi: 10.2147/JPR.S163975. eCollection 2018. — View Citation

Kiran S, Jinjil K, Tandon U, Kar S. Evaluation of dexmedetomidine and fentanyl as additives to ropivacaine for epidural anesthesia and postoperative analgesia. J Anaesthesiol Clin Pharmacol. 2018 Jan-Mar;34(1):41-45. doi: 10.4103/joacp.JOACP_205_16. — View Citation

Mohamad MF, Mohammad MA, Hetta DF, Ahmed EH, Obiedallah AA, Elzohry AAM. Thoracic epidural analgesia reduces myocardial injury in ischemic patients undergoing major abdominal cancer surgery. J Pain Res. 2017 Apr 12;10:887-895. doi: 10.2147/JPR.S122918. eCollection 2017. — View Citation

Soliman, Rabie & Eltaweel, Moataz. (2016). Comparative study of dexmedetomidine and fentanyl as an adjuvant to epidural bupivacaine for postoperative pain relief in adult patients undergoing total knee replacement: a randomized study. Journal of Anesthesiology and Clinical Science. 5. 1. 10.7243/2049-9752-5-1.

Yousef AA, Salem HA, Moustafa MZ. Effect of mini-dose epidural dexmedetomidine in elective cesarean section using combined spinal-epidural anesthesia: a randomized double-blinded controlled study. J Anesth. 2015 Oct;29(5):708-14. doi: 10.1007/s00540-015-2027-7. Epub 2015 May 26. — View Citation

Zhao Y, Xin Y, Liu Y, Yi X, Liu Y. Effect of Epidural Dexmedetomidine Combined With Ropivacaine in Labor Analgesia: A Randomized Double-Blinded Controlled Study. Clin J Pain. 2017 Apr;33(4):319-324. doi: 10.1097/AJP.0000000000000411. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Onset of sensory analgesia	will be assessed by pin prick and cold application from the start of epidural infusion till scoring 1 at the 3 point scale. Assessment will be done every 5 minutes until the onset of sensory block using a 3-point scale: 0=normal sensation, 1=loss of sensation of pin prick (analgesia), and 2=loss of sensation of touch (anesthesia).	24 hours
Primary	Duration of analgesia	time from starting epidural infusion to the time of the first request for additional pain medication	24 hours
Secondary	Postoperative pain score	for 24 hours using the Visual Analogue Scale ranging from 0 to 10 (0 - no pain, 10 - worst pain ever) at 0, 2, 6, 12 and 24 hrs after starting epidural infusion.	24 hours
Secondary	Analgesic consumption	during the 24 hours following epidural infusion.	24 hours
Secondary	The motor block	will be assessed if occurred by Bromage three point score (0-3) for the lower extremity during the 24 hours following epidural infusion where 0: no motor impairment (able to move the hip, knee, and ankle joints); unable to raise either extended leg (able to move joints of knee and ankle); unable to raise extended leg and flex knee (able to move joint of ankle); 3; unable to move knee and foot.	24 hours
Secondary	Post operative Mean arterial Blood pressure	Mean arterial pressure in mmHg will be monitored continuously and recorded just before the initiation of epidural infusion and thereafter at 2, 6, 12 and 24 hrs. postoperatively during the 24 hours following epidural infusion	24 hours
Secondary	Post operative Heart rate	Heart rate (HR) in beats per minute (bpm) will be monitored continuously and recorded just before the initiation of epidural infusion and thereafter at 2, 6, 12 and 24 hrs. postoperatively during the 24 hours following epidural infusion	24 hours
Secondary	Post operative Peripheral oxygen saturation	Peripheral oxygen saturation in blood (SpO2) will be monitored continuously and recorded just before the initiation of epidural infusion and thereafter at 2, 6, 12 and 24 hrs. postoperatively during the 24 hours following epidural infusion	24 hours
Secondary	Anticipated adverse events	like postoperative nausea and vomiting during the 24 hours from the start of epidural analgesia	24 hours

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