Clinical Comparative Study Aiming to Evaluate Postoperative Effect of Using Intrathecal Dexmedetomidine and Fentanyl as an Adjuvant to Heavy Bupivacaine in Lower Limb Vascular Surgeries on Pain Intensity, Analgesic Requirement and Shivering. Patients and Methods After Approval of Medical Institution

NCT07035223 | Completed Phase 4

• 1 other identifier: KFSIRB200-594
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Spinal anaesthesia is an excellent choice of numerous operating procedures. This is due to its effectiveness, rapid onset of action, easy to implement, patient stayed awake, and minimal drug cost.(1) It is also beneficial for patients with chronic airway disorders, reducing the risk of pulmonary aspiration and vomiting in patients with full stomach, as well as its fewer adverse effects, and speedy patient turnover. (2,1) In lower abdominal and lower limb surgeries, spinal anaesthesia is still the primary option. (3) The resultant nerve block is sufficient for patient welfare, while motor block eases the surgeon's work. Moreover, it grants efficient pain relief in the early post-operative period. (2) Yet, postoperative analgesia is a most important dilemma. (4) Thus, additional pain control is essential after spinal anaesthesia effect fades. Consequently, effective analgesia is crucial to accelerate rehabilitation and return to proper functional ability. Post-operative analgesia can be accomplished by numerous approaches specifically systemic opioid and non-opioid, local wound infiltration and peripheral nerve blocks, each approach have its own advantages and drawbacks.

Conditions

Postoperative Pain

Keywords

fentanyl; bupivacaine; spinal anaesthesia; vascular; dexmedetomidine

Outcome Measures

Primary Outcomes (3)

• evaluate postoperative effect of using intrathecal dexmedetomidine as an adjuvant to heavy bupivacaine in vascular lower limb surgeries on pain intensity.

  Pain had been assessed firstly every 1 hour for first 4 hours and subsequently till the patient required analgesia by means of "Visual Analogue Scale", It is lined scale, entails a 10 cm line attached at one end by a marker such as "No pain" and the other end by "Worst pain comprehendible". Patient just made mark on the line to denote the intensity of pain

  7 hours

• evaluate postoperative effect of using intrathecal dexmedetomidine as an adjuvant to heavy bupivacaine in vascular lower limb surgeries on analgesic requirements

  First analgesic requirement time was defined as from the time of spinal injection to the time the patient requires analgesia. The rescue analgesic used was Tramadol 50mg IV for visual analogue score of more than 4.

  7 hours

• evaluate postoperative effect of using intrathecal dexmedetomidine as an adjuvant to heavy bupivacaine in vascular lower limb surgeries on shivering. Remove

  The incidence and intensity of shivering would be also assessed postoperatively in the recovery room using the method of Tsai and Chu as follows: 0, no shivering 1. peripheral vasoconstriction without visible shivering 2. muscular activity in only one muscle group 3. muscular activity in more than one muscle group 4. shivering involving the whole body.

  7 hours

Secondary Outcomes (1)

• Complications would be noted post-operative

  7 hours

Study Arms (2)

Group D

ACTIVE COMPARATOR

Drug: 4 µg dexmedetomidine in 0.5 mL of normal saline intrathecal (dexmedetomidine 100 µg/mL will be diluted in 12.5 ml preservative-fr

Group F

ACTIVE COMPARATOR

Drug: fentanyl

Interventions

4 µg dexmedetomidine in 0.5 mL of normal saline intrathecal (dexmedetomidine 100 µg/mL will be diluted in 12.5 ml preservative-fr DRUG

Group D: patients will receive 3 mL volume of 0.5% hyperbaric bupivacaine and 4 µg dexmedetomidine in 0.5 mL of normal saline intrathecal (dexmedetomidine 100 µg/mL will be diluted in 12.5 ml preservative-free normal saline, 0.5 ml will be withdrawn)

Group D

fentanyl DRUG

Group F:patients will receive 3 mL volume of 0.5% hyperbaric bupivacaine with 25 µg fentanyl (0.5 mL) intrathecal.

Group F

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• The patient aged range from 20 to 60 years
• ASA 1 and 2
• Patient prepared for elective lower limb surgeries.
• Either sex male or female.

You may not qualify if:

• \- 1- Patient refusal. 2- Patient has absolute contraindication to spinal anaesthesia. 3- Patients with ASA 3 or more 4- Patients taking ACE inhibitor, adrenergic receptor antagonist and calcium channel blocker.
• Patients with head injury and polytrauma.

Sponsors & Collaborators

• Nashwa Ahmed: lead

Study Sites (1)

Port said university

Port Said, 42111, Egypt

Location

Related Publications (6)

• Bhure A, Jagtap N. A comparison of intrathecal dexmedetomidine and fentanyl as an adjuvant to isobaric levobupivacaine for lower limb orthopaedic surgery. Indian Journal of Clinical Anaesthesia 2019;6(1):89-96.

  RESULT

• Chandra GP, Krishna SS, Singh P. Comparison of effect of intrathecal dexmedetomidine and clonidine as an adjuvant to hyperbaric bupivacaine in patients undergoing surgery for fracture femur and tibia. Int Surg J. 2017 Dec;4(12):3833-3838.

  RESULT

• Reddy NG, Sekar RG, Ahmed CJ, Himabindu M, Mallika CH, Tejaswini PK. Intrathecal nalbuphine versus dexmedetomidine as an adjuvant in spinal anaesthesia for lower limb and lower abdominal surgeries. Journal of Cardiovascular Disease Research 2023;14(2): 825-830.

  RESULT

• Ahmed SA, Lotfy HA, Mostafa TAH. The effect of adding dexmedetomidine or dexamethasone to bupivacaine-fentanyl mixture in spinal anesthesia for cesarean section. J Anaesthesiol Clin Pharmacol. 2024 Jan-Mar;40(1):82-89. doi: 10.4103/joacp.joacp_396_22. Epub 2024 Mar 14.

  PMID: 38666154 RESULT

• Zhang Y, Shan Z, Kuang L, Xu Y, Xiu H, Wen J, Xu K. The effect of different doses of intrathecal dexmedetomidine on spinal anesthesia: a meta-analysis. Int J Clin Exp Med 2016;9(10):18860-18867.

  RESULT

• Khare A, Chohala M, Thada B , Mathur V, Garg D , Tanwar N. A study to compare the efficacy of intrathecal dexmedetomidine versus nalbuphine as an adjuvant to 0.5% hyperbaric bupivacaine for postoperative analgesia in lower abdominal surgeries. Ain-Shams Journal of Anesthesiology 2022;14(1):31.

  RESULT

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Dexmedetomidine; Fentanyl

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperidines

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: , Lecturer of Anaesthesia and Surgical Intensive Care, Faculty of Medicine, Port Said University, Egypt

Study Record Dates

• First Submitted: May 30, 2025
• First Posted: June 25, 2025
• Study Start: April 8, 2025
• Primary Completion: May 8, 2025
• Study Completion: May 30, 2025
• Last Updated: June 25, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)