Paravertebral Block for Pain Management After Appendectomy

Reduce Pain After Appendectomy Clinical Trial

Official title:

Paravertebral Block for Postoperative Pain Management in Adult Patients Undergoing Appendectomy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03189693
• Other study ID #: 212006
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2017
• Est. completion date: April 2022

Study information

• Verified date: January 2022
• Source: Makassed General Hospital
• Contact: Zoher Naja, MD
• Phone: +9611636000
• Email: zouhnaja[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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%.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: April 2022
• Est. primary completion date: April 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Reduce Pain After Appendectomy

Intervention

Other:
• PVB
nerve stimulator-guided PVB will be performed at two levels
• Placebo
nerve stimulator-guided PVB containing placebo will be performed at two levels
• GA
All patients will receive general anesthesia.
• Anesthetic injections
4 mL of the local anesthetic 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%.

Locations

Country	Name	City	State
Lebanon	Makassed General Hospital	Beirut

Sponsors (1)

Lead Sponsor	Collaborator
Makassed General Hospital

Country where clinical trial is conducted

Lebanon, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Analgesic consumption	The quantity of analgesics consumed will be recorded	24 hours postoperatively
Secondary	hemodynamic stability measured through mean arterial pressure (MAP).	Intraoperative hemodynamic stability measured through mean arterial pressure (MAP)	Approximately 1 hour