Dexamethasone/ Erector Spinae Plane Block Analgesia in Laparoscopic Cholecystectomy

Assiut University

Status and phase: Not yet enrolling; Phase 2

Conditions: Post Operative Pain

Treatments: Drug: Erector Spinae Plane Block; Drug: Dexamethasone/ Erector Spinae Plane Block

Study type: Interventional

Funder types: Other

Identifiers

NCT05105997

SM 10 2021

Details and patient eligibility

About

Although considered a minimally invasive procedure, laparoscopic cholecystectomy (LC) frequently results in moderate to severe immediate postoperative pain.

Full description

Although considered a minimally invasive procedure, laparoscopic cholecystectomy (LC) frequently results in moderate to severe immediate postoperative pain. In addition to predominant visceral pain, nearly half of all patients suffer from shoulder pain in the early postoperative period. The most likely reason is sub-diaphragmatic irritation, which is transmitted by the phrenic nerve, causing referred pain in the C4 dermatome. Due to multiple sources of pain, multimodal analgesia approaches have been used in the perioperative period following LC.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients undergoing elective LC under general anesthesia, ASA status I-II, aged from 18 to 65 years old of both sex

Exclusion criteria

• Contraindications to regional block (coagulopathy, infection at the needle insertion site, or diaphragmatic paralysis)
• Altered conscious level
• Pregnancy
• Body mass index (BMI > 35)
• Advanced hepatic or renal failure
• Chronic opioid consumption

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

60 participants in 2 patient groups, including a placebo group

Dexamethasone/ Erector Spinae Plane Block

Active Comparator group

Description:

Patients will receive bilateral Ultrasound-guided Erector Spinae Plane Block with bupivacaine and dexamethasone 15 minutes before skin incision.

Treatment:

Drug: Dexamethasone/ Erector Spinae Plane Block

Erector Spinae Plane Block

Placebo Comparator group

Description:

Patients will receive bilateral Ultrasound-guided Erector Spinae Plane Block with bupivacaine and one ml of normal saline 15 minutes before skin incision.

Treatment:

Drug: Erector Spinae Plane Block