Analgesia After Laparoscopic Cholecystectomy
Primary Purpose
Postoperative Pain
Status
Unknown status
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
USG-STAP with bupivacaine and dexmedetomidine
IP bupivacaine and dexmedetomidine
Sponsored by
About this trial
This is an interventional prevention trial for Postoperative Pain
Eligibility Criteria
Inclusion Criteria:
• Patients undergoing elective LC under general anesthesia, aged from 20 to 65 years old.
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)
- Patients who have difficulty understanding the study protocol 6- Patients who have any known contraindication to study medications 7- Patient refusal.
Sites / Locations
- Assiut UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Group I
Group II
Arm Description
Patients will receive USG-STAP block with bupivacaine and dexmedetomidine in both sides ten minutes before skin incision and intraperitoneal normal saline.
Patients will receive bupivacaine and dexmedetomidine through the intraperitoneal route and USG-STAP block with normal saline at the end of surgery
Outcomes
Primary Outcome Measures
The intensity of postoperative pain
Assessed by the numerical rating pain scale (NRS)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04715165
Brief Title
Analgesia After Laparoscopic Cholecystectomy
Official Title
Comparison of Subcostal Transversus Abdominis Block With Intraperitoneal Instillation of Bupivacaine and Dexmedetomidine for Pain Relief After Laparoscopic Cholecystectomy: A Randomized Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
August 7, 2021 (Actual)
Primary Completion Date
February 15, 2022 (Anticipated)
Study Completion Date
February 15, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Pain after laparoscopic cholecystectomy is common and may lead to delayed hospital discharge.
Detailed Description
Laparoscopic cholecystectomy (LC) is very commonly performed nowadays, and it has now completely replaced open cholecystectomy in the management of biliary lithiasis. Although it is minimally invasive surgery, pain in postoperative period is always major concern as it increases perioperative stress, morbidity, and hospital stay.
There are two components involved in pain after LC; the visceral component is due to tissue damage in anterior abdominal wall during the insertion of trocar and shoulder tip pain due to diaphragmatic irritation caused by Spillage of blood or bile and peritoneum stretching caused by pneumoperitoneum.
There are several methods employed in the management of postoperative pain after LC such as conventional systemic analgesics, including paracetamol, non-steroidal anti-inflammatory drugs, systemic opioids, thoracic epidural analgesia, low-pressure pneumoperitoneum, and warm air with all having its side effects .
Transversus abdominis plane (TAP) block has got a substantial role in postoperative analgesia after abdominal surgery because deposition of local anesthetics in transversus abdominis fascial plane can produce sensory block over the anterior abdominal wall from T7 to L1. Many clinical studies reported beneficial effects of TAP but results were mainly connected to lower abdominal surgery. Since the major part of pain after LC derives from abdominal wall incisions, some trials investigated TAP block as potential analgesic option. Some studies showed that TAP block can reduce opioid requirements and pain scores but the results were not conclusive enough because many differences in study designs.
The ultrasound-guided (USG) subcostal transversus abdominis plane block (STAP), first described by Hebbard 2008, is a variation of TAP which successfully solve the problem of unreliable supraumbilical distribution of the block. Results obtained in a few small studies showed significantly better analgesia after LC compare to traditional opioid analgesia, port-site infiltration and standard TAP.
Intraperitoneal (IP) instillation of local anaesthetics around the operative site is used as an analgesic technique on the assumption that conduction from visceral sites is obstructed and may lessen the intensity of referred pain to the shoulder (C3, C4) which results from irritation of diaphragmatic innervations, i.e., phrenic nerve (C3, C4, C5) and diaphragmatic stretching due to gaseous distension, in the postoperative period. Narchi I' et al., as early as in 1991 had reported that instillation of local anaesthetic (80 mL of bupivacaine 0.125%, epinephrine (1:200,000) under the right diaphragm reduced shoulder pain after minor gynaecologic laparoscopy.
Dexmedetomidine is a selective, short acting, agonist of the α2-adrenergic receptors. It has high affinity to α2-adrenergic receptors (more than eight-fold) and lower affinity to α1-receptors, compared with other α2-agonists agents, besides its great selectivity to α2A-adrenergic receptors, which is responsible for its analgesic effect. It has been used clinically as an adjunct to anesthesia and analgesia, and it is useful for painful surgical procedure and ICU sedation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group I
Arm Type
Active Comparator
Arm Description
Patients will receive USG-STAP block with bupivacaine and dexmedetomidine in both sides ten minutes before skin incision and intraperitoneal normal saline.
Arm Title
Group II
Arm Type
Placebo Comparator
Arm Description
Patients will receive bupivacaine and dexmedetomidine through the intraperitoneal route and USG-STAP block with normal saline at the end of surgery
Intervention Type
Drug
Intervention Name(s)
USG-STAP with bupivacaine and dexmedetomidine
Intervention Description
Patients will receive USG-STAP block with bupivacaine and dexmedetomidine in both sides ten minutes before skin incision and intraperitoneal normal saline
Intervention Type
Drug
Intervention Name(s)
IP bupivacaine and dexmedetomidine
Intervention Description
Patients will receive bupivacaine and dexmedetomidine through the intraperitoneal route and USG-STAP block with normal saline at the end of surgery
Primary Outcome Measure Information:
Title
The intensity of postoperative pain
Description
Assessed by the numerical rating pain scale (NRS)
Time Frame
24 hours after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
• Patients undergoing elective LC under general anesthesia, aged from 20 to 65 years old.
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)
Patients who have difficulty understanding the study protocol 6- Patients who have any known contraindication to study medications 7- Patient refusal.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Seham M Moeen, MD
Phone
01006386324
Ext
02
Email
seham.moeen@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Dina H Ahmed, Msc
Phone
01008207874
Ext
02
Email
Dr_dina_ahmed84@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Seham M Moeen, MD
Organizational Affiliation
Assiut University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Assiut University
City
Assiut
ZIP/Postal Code
71515
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Seham M Moeen, M.D.
Phone
01006386324
Ext
02
Email
seham.moeen@aun.edu.eg
12. IPD Sharing Statement
Learn more about this trial
Analgesia After Laparoscopic Cholecystectomy
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