Paravertebral Block for Pain Management After Appendectomy

Not Applicable

• Conditions: Reduce Pain After Appendectomy
• Interventions: Other: PVB; Other: Placebo; Other: GA; Other: Anesthetic injections

• Registration Number: NCT03189693
• Lead Sponsor: Makassed General Hospital

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 Timeline

• Study Start: 2017-06-01
• Study First Submitted: 2017-06-13
• Study First Submitted QC: 2017-06-15
• Study First Posted: 2017-06-16
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-14
• Last Update Posted: 2022-01-18
• Primary Completion: 2022-04
• Study Completion: 2022-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PVB group	GA	Patients will receive two PVB injections at levels T12-L1 and L1-L2 using anesthetic mixture
PVB group	PVB	Patients will receive two PVB injections at levels T12-L1 and L1-L2 using anesthetic mixture
PVB group	Anesthetic injections	Patients will receive two PVB injections at levels T12-L1 and L1-L2 using anesthetic mixture
Placebo	Placebo	Patients will receive two PVB injections containing placebo at levels T12-L1 and L1-L2
Placebo	GA	Patients will receive two PVB injections containing placebo at levels T12-L1 and L1-L2

Primary Outcome Measures

Name	Time	Method
Analgesic consumption	24 hours postoperatively	The quantity of analgesics consumed will be recorded

Secondary Outcome Measures

Name	Time	Method
hemodynamic stability measured through mean arterial pressure (MAP).	Approximately 1 hour	Intraoperative hemodynamic stability measured through mean arterial pressure (MAP)

Trial Locations

Locations (1)

Makassed General Hospital; 🇱🇧 Beirut, Lebanon