Effects of Intrathecal Dexmedetomidine as an Adjuvant to Low Dose Hyperbaric 0.5% Bupivacaine
Condition: Post Operative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 4

Summary: 
      Patients will be enrolled in one of the two groups using a computer-generated random number
      table: Group I will receive 1.5 ml of 0.5% hyperbaric bupivacaine (7.5 mg). Group II will
      receive 1.2 mL of 0.5% hyperbaric bupivacaine (6 mg) along with 0.3 mL (3 μg )of
      dexmedetomidine (total 1.5 mL).
    

Detailed description: 
      After approval of the synopsis and permission from the hospital ethics committee, all
      patients meeting the inclusion criteria will be included in the study. Patients will be
      instructed not to consume solid food after midnight before surgery and to take clear liquids
      up to 2 hours before surgery. Using a computer-generated random number table, patients will
      be enrolled in one of the two groups: Group I will receive 1.5 ml of 0.5% hyperbaric
      bupivacaine (7.5 mg). Group II will receive 1.2 mL of 0.5% hyperbaric bupivacaine (6 mg)
      along with 0.3 mL (5 μg )of dexmedetomidine (total of 1.5 mL). They will be randomly
      allocated into two groups using the sealed envelope technique by a person blinded to the
      procedure. The study medication will be prepared by an anaesthesiologist not involved in the
      study and another anaesthesiologist performing the spinal block will record the
      intraoperative and postoperative data. On arrival at the Operating Room (OR) monitors like a
      non-invasive blood pressure monitor (NIBP), peripheral oxygen saturation monitor (SpO2), and
      electrocardiography monitor (ECG) having lead II will be attached. All the baseline values of
      blood pressure (SBP, DBP, and MAP), heart rate and rhythm, and SPO2 will be observed and
      recorded. An intravenous (IV) line will be established with an 18-gauge cannula. The study
      drug solutions will look identical. For Group I, 7.5 mg(1.5 mL) of 0.5% hyperbaric
      bupivacaine hydrochloride will be drawn in a 3 mL BD syringe. For Group II, 6mg (1.3 mL) of
      0.5% hyperbaric bupivacaine hydrochloride will be drawn in a 3 mL BD syringe. By using an
      insulin syringe, 0.3 mL (3 μg) of Dexmedetomidine (preservative free) 100 μg/mL will be added
      to the 6 mg (1.3 mL) of hyperbaric bupivacaine under complete aseptic conditions to bring the
      total volume to 1.5 mL. The total volume of drug solutions will be 1.5 mL in each group.

      Local infiltration of the skin with 2mL of 2% lidocaine will be done to decrease the
      discomfort caused by the spinal needle. A spinal puncture will be performed at L3-L4 or L4-L5
      with a midline approach using a 25-gauge Quincke needle in the sitting position. After
      verification of clear and free flow of cerebrospinal fluid, the drug will be administered and
      the patients will be placed in the supine position Vitals will be monitored Heart Rate (HR),
      systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP),
      respiratory rate (RR), oxygen saturation (SpO2) for every 5 minutes till the end of surgery.
      If mean arterial pressure (MAP) decreases below 65 mmHg or the Heart rate falls below 65
      beats per minute then intravenous vasopressors will be given. The sensory block levels will
      be checked on the bilateral mid-clavicular line with a pin prick with a blunt needle every 2
      min from the time of drug injection until the sensory level achieves up to T10 level.

      In contrast, the motor block will be assessed using the modified Bromage scale. The surgeon
      will be asked to start the surgery when the sensory block has reached the T10 level. After
      completion of the surgery, the patient will be shifted to the PACU and monitored for 3 hours
      with continuous ECG monitoring and intermittent non-invasive blood pressure monitoring at
      5-minute intervals. All untoward events like shivering, nausea vomiting, sedation, and
      respiratory depression will be monitored and recorded in the operating room as well as in the
      recovery room.

      All data will be recorded on Performa attached as Annex A after the consultant anesthetist
      confirms.
    

Intervention name(s): Bupivacain 0.5%; Dexmedetomidine Hydrochloride
Intervention type(s): Drug; Drug
Intervention description(s): Bupivacaine hydrochloride was given without any adjuvant; Use of Dexmedetomidine Hydrochloride 5 micrograms (1 mL) as an adjuvant with bupivacaine hydrochloride
Other intervention name(s): Pure Bupivacain 0.5%; Dexmedetomidine 5 microgram
Intervention MeSH terms: Dexmedetomidine; Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Group BUPPURE will receive 1.5 ml of hyperbaric 0.5% bupivacaine (1.5 ml/7.5 mg) whereas the BUPIDEX group will receive Dexmedetomidine 3 micrograms (0.3mL)with hyperbaric 0.5% bupivacaine (1.2 ml/6 mg) to be given to one group.
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Supportive Care