Paravertebral Block for Postoperative Pain Management in Adult Patients Undergoing Appendectomy
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Makassed General Hospital
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Analgesic consumption
Study Overview
Brief Summary
Paravertebral Block (PVB) was shown to be a successful and useful technique of anesthesia and analgesia. Its effect was evident in thoracic and abdominal surgeries. In the setting of appendectomy, somatic PVB has been used for pediatric patients. It was shown to decrease opioid consumption and provide prolonged pain relief. Hence, it would be beneficial to examine the analgesic effect of PVB on appendectomy in adult patients.
Detailed Description
Patients undergoing appendectomy will be randomly allocated into two equal groups using the sealed envelope technique. All patients will receive general anesthesia (GA). Patients in group I will receive two PVB injections at levels T12-L1 and L1-L2 using anesthetic mixture, while patients in Group II will receive placebo.
Paravertebral Block Technique Unilateral right side nerve stimulator-guided PVB is performed while patients are in the left lateral decubitis position. The appropriate levels for the PVB are determined by palpation of the spinous processes. An intervertebral line is drawn at the appropriate levels and the injection site is marked 2.5 cm lateral to the midline. After aseptic preparation of the skin, 1 mL 1% lidocaine is infiltrated at the injection sites. A 21-G nerve stimulation needle (Stimuplex; B. Braun, Melsungen, Germany) is advanced 1-2 cm perpendicularly to the skin using a nerve stimulating current of 2.5-5.0 mA, while closely watching for contractions of the abdominal muscles. The tip of the needle is adjusted to maintain muscle contractions while reducing the stimulating current to approximately 0.5-0.6 mA.
4 mL of the local anaesthetic mixture is injected at each injection site. Each 20 mL of the local anaesthetic mixture contains: 8mL lidocaine 2%, 8 mL lidocaine 2% with epinephrine 5µg/mL and 4 mL bupivacaine 0.5%.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 19 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Older than 18 years
- •Scheduled to undergo appendectomy
Exclusion Criteria
- •cardiac disease,
- •developmental delay,
- •neurologic deficit,
- •allergies to any of the drugs routinely used in anesthesia management.
Arms & Interventions
PVB group
Patients will receive two PVB injections at levels T12-L1 and L1-L2 using anesthetic mixture
Intervention: PVB (Other)
PVB group
Patients will receive two PVB injections at levels T12-L1 and L1-L2 using anesthetic mixture
Intervention: GA (Other)
PVB group
Patients will receive two PVB injections at levels T12-L1 and L1-L2 using anesthetic mixture
Intervention: Anesthetic injections (Other)
Placebo
Patients will receive two PVB injections containing placebo at levels T12-L1 and L1-L2
Intervention: GA (Other)
Placebo
Patients will receive two PVB injections containing placebo at levels T12-L1 and L1-L2
Intervention: Placebo (Other)
Outcomes
Primary Outcomes
Analgesic consumption
Time Frame: 24 hours postoperatively
The quantity of analgesics consumed will be recorded
Secondary Outcomes
- hemodynamic stability measured through mean arterial pressure (MAP).(Approximately 1 hour)
Investigators
Zoher Naja
Chairperson of Anesthesia and Pain Management Department
Makassed General Hospital