Clinical trial NCT04370392: Intraperitoneal Versus Intravenous Dexmedetomidine for Post-operative Analgesia Following Laparoscopic Sleeve Gastrectomy Surgery
Official title: Intraperitoneal Versus Intravenous Dexmedetomidine for Post-operative Analgesia Following Laparoscopic Sleeve Gastrectomy Surgery, A Prospective Randomized Control Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain After Laparoscopic Sleeve Gastrectomy
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2020-04-30
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: One of most common bariatric surgery is laparoscopic sleeve gastrectomy. Pain after laparoscopic surgery may be due to stretching of the intra-abdominal cavity, peritoneal inflammation, and diaphragmatic irritation caused by residual carbon-dioxide in the peritoneal cavity.Multimodal efforts like parenteral opioids, non-steroidal anti-inflammatory drugs or local wound infiltration have been done to reduce overall pain and benefit post-operative conditions of patients undergoing laparoscopic surgeries. Despite their efficacy, with all parenteral medications, there are associated adverse effects.

Intraperitoneal local anesthetic is a safe and effective analgesic approach which used to control pain after laparoscopic surgery. Many authors have evaluated the role of IP local anesthetic administration in laparoscopic colorectal cancer surgery, laparoscopic cholecystectomy, laparoscopic appendectomy and laparoscopic hysterectomy

Detailed description: Laparoscopic procedures have many advantages over open procedures such as lesser haemorrhage, better cosmetic results, lesser post-operative pain, and shorter recovery time, leading to shorter hospital stay and less expenditure.One of most common bariatric surgery is laparoscopic sleeve gastrectomy. Pain after laparoscopic surgery may be due to stretching of the intra-abdominal cavity, peritoneal inflammation, and diaphragmatic irritation caused by residual carbon-dioxide in the peritoneal cavity.

Multimodal efforts like parenteral opioids, non-steroidal anti-inflammatory drugs or local wound infiltration have been done to reduce overall pain and benefit post-operative conditions of patients undergoing laparoscopic surgeries. Despite their efficacy, with all parenteral medications, there are associated adverse effects.

Intraperitoneal local anesthetic is a safe and effective analgesic approach which used to control pain after laparoscopic surgery. Many authors have evaluated the role of IP local anesthetic administration in laparoscopic colorectal cancer surgery, laparoscopic cholecystectomy, laparoscopic appendectomy and laparoscopic hysterectomy.

Dexmedetomidine (alpha-2 adrenergic agonists) has become one of the frequently used drugs in anesthesia as it has been reported to provide analgesia, anxiolysis, and an anesthetic-sparing action with minimal respiratory depression plus its sedative effect that mimics natural sleep. Dexmedetomidine can used safely both intravenous and plus bupivacaine in different nerve block.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing laparoscopic sleeve gastrectomy who meet the known criteria for bariatric procedures (BMI ≥ 40 or 35 with comorbidities related to obesity or obesity for more than 5 years with all efforts to reduce weight failing).

Exclusion Criteria:

* 1. Cardiac patients, 2. patients with known allergy to bupivacaine, 3. prolonged administration of NSAIDS or other analgesics due to chronic pain of any reason, 4. severe renal and hepatic diseases, 5. on antihypertensive medication with any α2 adrenergic agonists, e.g., clonidine or beta blockers 6. heart block.

Primary outcomes:
measure: Time of first analgesic request
timeFrame: postoperative first day
Secondary outcomes:
measure: postoperative pain assessment
timeFrame: postoperative first day
measure: Total amount of rescue analgesia
timeFrame: postoperative first day
measure: Number of patients who needed postoperative rescue analgesia
timeFrame: postopertive first day
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tarek Abdel Hay
state: El Gharbyia
Study officials:
References: