Paravertebral Block for Pain Management After Appendectomy

Makassed General Hospital

Status: Unknown

Conditions: Reduce Pain After Appendectomy

Treatments: Other: Anesthetic injections; Other: Placebo; Other: GA; Other: PVB

Study type: Interventional

Funder types: Other

Identifiers

NCT03189693

212006

Details and patient eligibility

About

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.

Full 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%.

Enrollment: 60 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 2 patient groups, including a placebo group

PVB group

Experimental group

Description:

Patients will receive two PVB injections at levels T12-L1 and L1-L2 using anesthetic mixture

Treatment:

Other: Anesthetic injections

Other: GA

Other: PVB

Placebo

Placebo Comparator group

Description:

Patients will receive two PVB injections containing placebo at levels T12-L1 and L1-L2

Treatment:

Other: GA

Other: Placebo