Effect of Ultrasound-enhanced Bee Venom on Selected Post Inguinal Hernioplasty Complications
Condition: Complications; C, Intestinal (Internal)
Study type: Interventional

Summary: 
      Objectives: Bee venom phonophoresis has been suggested as a noninvasive treatment for a
      number of inflammatory conditions and to reduce postoperative pain. The aim of this study was
      to evaluate the effect of bee venom phonophoresis on selected acupuncture points for the
      treatment of pain, inflammation, and mobility of the hip following inguinal hernioplasty.

      HYPOTHESES:

      It will be hypothesized that:

      It was hypothesized that Bee venom phonophoresis has no or limited effect in improvement of
      post inguinal hernioplasty complication.

      RESEARCH QUESTION: Does Bee venom phonophoresis an effect in improvement of post inguinal
      hernioplasty complication?
    

Detailed description: 
      All patients in both groups of the study (A) and (B) would receive a noncontact low-frequency
      pulsed ultrasound delivered through a fine mist of sterile saline or alcohol at the
      incisional site of inguinal hernioplasty, REN 4 and REN 6. Treatment sessions were 3 sessions
      a week for 3 consecutive weeks. Before and after each patient exposure, the ultrasonic
      applicator's performance was tested on a regular basis, and each test included all essential
      acoustic field characteristics (pressure amplitude, frequency), as well as the uniformity of
      the field distribution.

      Ren 4: On the anterior midline, 2 sun superior to the upper border of the pubic symphysis or
      3 sun inferior to the umbilicus. Ren 6: On the anterior midline, 1.5 sun inferior to the
      umbilicus or 3.5 sun superior to the upper border of the pubic symphysis.

      For the bee venom phonophoresis group (A): A single clinical dosage of diluted bee venom (BV)
      in normal saline, 0.05 ml (1 g/ml), was injected into the forearm via either an intradermal
      or subcutaneous method to test for BV allergy. Subjects might take part in this study if the
      examined lesion caused a wheal with a diameter of less than 10 mm and an erythema with a
      diameter of less than 26.5 mm after 10 to 15 minutes.28 Participants were treated with BV
      previously prepared gel as topical application using an ultrasonic therapy instrument with
      frequency, 0.5-megahertz pulsed mode (applicator 1.9 cm2) applied around the incision site.
      The movement was over the incision margins with a pulsed duty cycle of 40% (4 ms on, 6 ms
      off), and power density of 0.5 W/cm2, and time was 5 minutes each session. Each participant
      was put in the most comfortable and relaxed position as a supine lying position, and the
      patient was asked to expose the incision site to avoid any restriction for receiving
      phonophoresis around the incisional site, REN 4 and REN 6. The incision margin was cleaned
      with alcohol or normal saline, the ultrasound unit's plug was inserted into the main current
      supply, and the treatment approach (phonophoresis application for bee venom gel) was
      prepared; each participant received a total amount of about 0.6 mg to 1 mg of BV gel each
      session for a total of 5 minutes.29 The participants in the control group (Group B) received
      only low-intensity pulsed ultrasound applied around the incisional site, REN 4 and REN 6 for
      5 minutes, as in Group A, using only plain gel without BV gel.
    

Intervention name(s): bee venom gel phonophoresis; low intensity ultrasound
Intervention type(s): Combination Product; Device
Intervention description(s): a noncontact low-frequency pulsed ultrasound delivered through Bee Venom previously prepared gel as topical application using an ultrasonic therapy instrument with frequency, 0.5-MHZ pulsed mode (applicator 1.9 cm2) applied around the incision site, Ren 4 and Ren 6. The movement was over the incision margins, Ren 4 and Ren 6 with a pulsed duty cycle of 40% (4 ms on, 6 ms off), and power density of 0.5 W/cm2, Before and after each patient exposure, the ultrasonic applicator's performance was tested on a regular basis, and each test included all essential acoustic field characteristics (pressure amplitude, frequency), as well as the uniformity of the field distribution.; a noncontact low-frequency pulsed ultrasound delivered through plain gel only using an ultrasonic therapy instrument with frequency, 0.5-MHZ pulsed mode (applicator 1.9 cm2) applied around the incision site, Ren 4 and Ren 6. The movement was over the incision margins, Ren 4 and Ren 6 with a pulsed duty cycle of 40% (4 ms on, 6 ms off), and power density of 0.5 W/cm2, Before and after each patient exposure, the ultrasonic applicator's performance was tested on a regular basis, and each test included all essential acoustic field characteristics (pressure amplitude, frequency), as well as the uniformity of the field distribution.
Other intervention name(s): low intensity Ultrasound with bee venom gel
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: phonophoresis, inguinal hernioplasty, bee venom