Dexamethasone and Dexmedetomidine Versus Dexmedetomidine Alone With Bupivacaine in Ultrasound Guided Rectus Sheath Block

NCT06942884 | Active Not Recruiting

• 1 other identifier: 0108165
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Major abdominal surgery involves a variety of surgical procedures on a variety of patients, necessitating a broad spectrum of pain and analgesic needs. A crucial element of multimodal analgesia that spares the use of opioids is regional anaesthesia. Rectus sheath block (RSB) is a common regional block for post-operative analgesia after abdominal surgeries with midline incisions. A good analgesic effect has been reported for upper as well as lower abdominal midline incisions.(2) It was firstly described in 1899 with the aim of deposition of local anaesthetic (LA) in the virtual space between the posterior wall of the rectus abdominis muscle and its sheath. The anaesthetic injected into this space is proposed to spread freely up and down to block the anterior branches of the thoracoabdominal nerves before they emerge from the rectus sheath. The ventral branches of the lower thoracic nerves (T6-T12), which are located between the rectus abdominis muscle and its sheath, innervate the central region of the anterior abdominal wall. In general, a single injection of local anesthetic can give analgesia for 4-12 hours following surgery, depending on the drug's chemical composition and degree of lipid solubility. Since postoperative pain might last for several days, prolonging the duration of action of local anaesthetics is important.(5) To prolong the postoperative analgesic period of local anaesthetics, many adjuncts have been used, including fentanyl, neostigmine, clonidine, and most recently dexamethasone and dexmedetomidine.(6) Dexamethasone is a highly potent, long-acting glucocorticoid. It reduces the activity of nociceptive C-fibres via binding to glucocorticoid receptors, which inhibits potassium conductance. It may also lengthen the duration of analgesia by systemic anti-inflammatory actions and local vasoconstrictive action. Dexmedetomidine is one of the α -adrenoceptor agonists with α2 -adrenoceptor selectivity with both analgesic and sedative properties. it shortens the duration of the sensory and motor blockade while lengthening the initial blocking time when used as a perineural adjuvant

Conditions

Dexmedetomidine; Dexamethasone; Abdominal Surgeries

Outcome Measures

Primary Outcomes (1)

• postoperative opioid consumption

  mg

  postoperative day 2

Secondary Outcomes (3)

• postoperative pain score

  postoperative day 2

• quality of recovery 15

  postoperative day 2

• complications

  postoperative day 2

Study Arms (2)

group 1

EXPERIMENTAL

Patients will receive bilateral RSB with 20 ml on each side containing 10 ml 0.5% bupivacaine, 20μg dexmedetomidine, 4mg dexamethasone and normal saline.

Drug: Dexmedetomidine and dexamethasone in addition to bupivacaine in rectus sheath block

group 2

ACTIVE COMPARATOR

Patients will receive bilateral RSB with 20 ml on each side containing 10 ml 0.5 bupivacaine, with 4mg dexamethasone and normal saline

Drug: dexamethsone in addition to bupivacaine in rectus sheath block

Interventions

Dexmedetomidine and dexamethasone in addition to bupivacaine in rectus sheath block DRUG

addition of dexmedetomidine to dexamethasone in rectus sheath block

Also known as: group 1

group 1

dexamethsone in addition to bupivacaine in rectus sheath block DRUG

addition of dexamethasone in rectus sheath block

Also known as: group 2

group 2

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• American Society of Anaesthesiologists (ASA) physical status I and II.
• Patients aged 18-50 years.
• Body mass index (BMI) less than 30 kg/m2.
• Patients indicated for open abdominal surgeries with midline skin incision under general anaesthesia.
• Elective and haemodynamically stable emergency cases.

You may not qualify if:

• Patients' refusal.
• History of allergy to any of the study medications.
• Diabetic patients.
• Contraindications to regional anaesthesia, coagulopathy, anatomical abnormalities, haemodynamic instability, local infection, and suspected intra-abdominal sepsis.

Sponsors & Collaborators

• sarah mohamed: lead

Study Sites (1)

Alexandria University

Alexandria, Egypt

Location

Related Publications (1)

• Pirie K, Traer E, Finniss D, Myles PS, Riedel B. Current approaches to acute postoperative pain management after major abdominal surgery: a narrative review and future directions. Br J Anaesth. 2022 Sep;129(3):378-393. doi: 10.1016/j.bja.2022.05.029. Epub 2022 Jul 6.

  PMID: 35803751 BACKGROUND

MeSH Terms

Interventions

Dexmedetomidine; Dexamethasone

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• sarah m elgamal, MD

  Alexandria University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: lecturer

Study Record Dates

• First Submitted: April 17, 2025
• First Posted: April 24, 2025
• Study Start: January 30, 2024
• Primary Completion: June 1, 2025
• Study Completion: December 1, 2025
• Last Updated: April 24, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)