Dexmedetomidine Versus Magnesium Sulfate as Adjuvants to Intraperitoneal Bupivacaine for Postoperative Analgesia After Elective Laparoscopic Cholecystectomy

Tanta University

Status: Completed

Conditions: Intraperitoneal Bupivacaine; Postoperative Analgesia; Adjuvants; Dexmedetomidine; Magnesium Sulfate; Elective Laparoscopic Cholecystectomy

Treatments: Drug: Bupivacaine; Drug: Magnesium sulfate; Drug: Dexmedetomidine

Study type: Interventional

Funder types: Other

Identifiers

NCT06879288

36264MS215/6/23

Details and patient eligibility

About

This study aimed to assess the efficiency of dexmedetomidine against magnesium sulfate as adjuvants to intraperitoneal bupivacaine for postoperative analgesia in individuals having elective laparoscopic cholecystectomy.

Full description

Pain after laparoscopy is less intense than after laparotomy, but laparoscopy is not pain free and analgesia after this type of surgery is inadequately studied. Intraperitoneal (IP) instillation/nebulization of local anesthetics has been used as a method for reducing postoperative pain and opioid use following laparoscopy through acting on visceral nociceptors of the peritoneum.

Bupivacaine is indicated for local infiltration, peripheral nerve block, sympathetic nerve block, and epidural and caudal blocks. It is available mixed with a small amount of epinephrine to increase the duration of its action. It typically begins working within 15 minutes and lasts for 2 to 8 hours.

Dexmedetomidine is a selective alpha-2 (α2) adrenergic agonist known to have analgesic and sedative characteristics that can augment the duration of action of local anesthetics.

Magnesium is an N-methyl-D-aspartate receptor antagonist in addition to its effects on calcium influx. The anti-inflammatory and opioid-sparing effects make it a popular component of opioid free anaesthesia. It is extensively used for perioperative analgesia in a dose of 30- to 50-mg/kg intravascular bolus followed by a 10- to 15-mg/kg/h infusion.

Enrollment: 75 patients

Sex: All

Ages: 21 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age from 21 to 65 years.
• Both sexes.
• American Society of Anesthesiologists (ASA) class I-III.
• Scheduled to undergo elective laparoscopic cholecystectomy.

Exclusion criteria

• Patient refusal.
• Body mass index ≥40.
• Allergy to the study drugs.
• Advanced cardiac, renal and hepatic diseases.
• Patients with peritoneal drain or peritoneal wash after surgery.
• Uncooperative patients.
• Chronic pain medications.
• Hypomagnesaemia or hypermagnesaemia.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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75 participants in 3 patient groups

Bupivacaine group

Active Comparator group

Description:

Patients received intraperitoneal bupivacaine only at the end of the operations.

Treatment:

Drug: Bupivacaine

Dexmedetomidine group

Experimental group

Description:

Patients received intraperitoneal bupivacaine plus dexmedetomidine at the end of the operations.

Treatment:

Drug: Dexmedetomidine

Magnesium group

Experimental group

Description:

Patients received intraperitoneal bupivacaine plus magnesium sulfate at the end of the operations.

Treatment:

Drug: Magnesium sulfate