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Intraperitoneal Tramadol Versus Dexmedetomedine for Analgesia After Abdominal Laparoscopic Cancer Surgeries

Primary Purpose

Analgesia

Status
Completed
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Tramal 1
Tramal 2
Dexmedetomidine 1
dexmedetomidine 2
Sponsored by
National Cancer Institute, Egypt
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Analgesia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • ASA II or III.
  • Age 18 to 65 years.
  • Elective surgeries

Exclusion Criteria:

  • Patients with severe hepatic (more than child c), renal (known CKD)and cardiac (known IHD) troubles.
  • Patients with extensive intraperitoneal adhesions.
  • Patients with a history of drug or analgesic abuse.
  • Known drug allergy or indigestion.
  • Intraoperative lavage of more than 500ml.

Sites / Locations

  • National Cancer Institute

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Early tramal/bupivacaine

Late tramal/bupivacaine

Early dexmedetomedine/bupivacaine

Late dexmedetomedine/bupivacaine

Arm Description

patients received 50 ml of isotonic aqueous solution (PH 7.45) of tramadol 150mg mixed with bupivacaine 0.25% immediately before creation of a pneumoperitoneum and placement of the first two trocars before starting the surgery.

patients received 50ml of isotonic aqueous solution (PH 7.45) of tramadol 150mg mixed with bupivacaine 0.25% after completion of surgery and before trocars removal.

patients received 50ml of isotonic aqueous solution (PH 7.45) of dexmedetomedine(1µ/kg) mixed with bupivacaine 0.25% before creation of a pneumoperitoneum and placement of the first two trocars before the start of surgery.

patients received 50ml of isotonic aqueous solution (PH 7.45) of dexmedetomedine(1µ/kg) mixed with bupivacaine 0.25% after completion of surgery and before trocars removal.

Outcomes

Primary Outcome Measures

The degree of pain
measurement of VAS

Secondary Outcome Measures

Full Information

First Posted
March 20, 2021
Last Updated
June 1, 2022
Sponsor
National Cancer Institute, Egypt
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1. Study Identification

Unique Protocol Identification Number
NCT04813016
Brief Title
Intraperitoneal Tramadol Versus Dexmedetomedine for Analgesia After Abdominal Laparoscopic Cancer Surgeries
Official Title
Comparative Study Between Intraperitoneal Administration of Either Bupivacaine and Tramadol Versus Bupivacaine and Dexmedetomedine for Analgesia After Abdominal Laparoscopic Cancer Surgeries. A Prospective Randomized Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
March 1, 2021 (Actual)
Primary Completion Date
April 30, 2022 (Actual)
Study Completion Date
May 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Cancer Institute, Egypt

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Multiple modalities for postoperative analgesia after laparoscopic procedures has been used, of them intraperitoneal route (IP) was used to decrease the analgesic requirements. Both early and late bupivacaine and tramadol versus bupivacaine and dexmedetomedine will be tried to choose which is having a better analgesic profile.
Detailed Description
Recently laparoscopic procedures have become popular and familiar to both surgeons and anesthetists. They have many advantages such as rapid postoperative recovery, low postoperative complication rates, early mobilization, and early home discharge; consequently reduce hospital stay and costs. Although previous studies have been shown that laparoscopy is associated with less pain than laparotomy, it is not totally pain free. Some laparoscopic procedures for abdominal cancer surgeries has shown that there may be more intense pain and greater analgesic requirements in the immediate postoperative period than after open laparotomy. Thoroughly understanding the difference of pain generators in laparotomy than in laparoscopy gave some ideas helping in the control of each of them. While laparotomy results mainly in parietal pain, visceral pain remains predominantly in patients after laparoscopic surgeries resulting from the stretching of intra-abdominal cavity, peritoneal inflammation and phrenic nerve irritation caused by residual carbon dioxide in the peritoneal cavity resulting in postoperative abdominal and shoulder pain after laparoscopy. Hence, Intraperitoneal (IP) administration of some drugs can be effective for pain relief after laparoscopic surgery. The results have been variable as the published studies are heterogeneous and often lack appropriate controls. For that, no definitive conclusion can yet be made regarding its value and effectiveness. The α2-adrenergic agonist provides excellent sedation, anxiolysis, analgesia and sympatholysis. Of them, dexmedetomidine has become one of the frequently used drugs in anaesthesia aiming to its hemodynamic, sedative, anxiolytic, analgesic, neuroprotective and anaesthetic sparing effect. In addition, the high selectivity of dexmedetomidine to α2- receptors favored its widespread use in regional anaesthesia practice and local nerve blocks techniques. As noradrenergic neurons descending through the dorso-lateral funiculus from the brainstem to the dorsal horn significantly contribute in the modulation of pain by controlling impulse transmission (descending inhibitory pathway). Adrenergic agonists, such as dexmedetomedine, possess significant antinociceptive activity by a central action on the brainstem and a spinal action on the substantia gelatinosa of the dorsal horn. Tramadol is a synthetic opioid pain medication used to treat moderate to moderately severe pain. It exerts its analgesic effects through a variety of different targets on the noradrenergic, serotoninergic and opioid receptors systems. It also exists as a racemic mixture, the positive enantiomer inhibits serotonin reuptake while the negative enantiomer inhibits noradrenaline re-uptake, by binding to and blocking the transporters. Finally, tramadol has also been shown to act as a serotonin releasing agent. Both enantiomers of tramadol are agonists of the μ-opioid receptor and its M1 metabolite, O-demethylate, which is also a μ-opioid receptor agonist but is 6 times more potent than tramadol itself. All these effects work synergistically to induce analgesia. The aim of this study is to examine and compare the effect of both early and late intraperitoneal bupivacaine/tramadol and bupivacaine/dexmedetomedine analgesia on the effectiveness of postoperative analgesia and the requirement of postoperative rescue analgesics after laparoscopic surgery for abdominal cancer surgeries.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Analgesia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Early tramal/bupivacaine
Arm Type
Active Comparator
Arm Description
patients received 50 ml of isotonic aqueous solution (PH 7.45) of tramadol 150mg mixed with bupivacaine 0.25% immediately before creation of a pneumoperitoneum and placement of the first two trocars before starting the surgery.
Arm Title
Late tramal/bupivacaine
Arm Type
Active Comparator
Arm Description
patients received 50ml of isotonic aqueous solution (PH 7.45) of tramadol 150mg mixed with bupivacaine 0.25% after completion of surgery and before trocars removal.
Arm Title
Early dexmedetomedine/bupivacaine
Arm Type
Active Comparator
Arm Description
patients received 50ml of isotonic aqueous solution (PH 7.45) of dexmedetomedine(1µ/kg) mixed with bupivacaine 0.25% before creation of a pneumoperitoneum and placement of the first two trocars before the start of surgery.
Arm Title
Late dexmedetomedine/bupivacaine
Arm Type
Active Comparator
Arm Description
patients received 50ml of isotonic aqueous solution (PH 7.45) of dexmedetomedine(1µ/kg) mixed with bupivacaine 0.25% after completion of surgery and before trocars removal.
Intervention Type
Drug
Intervention Name(s)
Tramal 1
Other Intervention Name(s)
Early tramal
Intervention Description
Early intraperitoneal injection of tramal and bupivacaine
Intervention Type
Drug
Intervention Name(s)
Tramal 2
Other Intervention Name(s)
Late tramal
Intervention Description
Late intraperitoneal injection of tramal and bupivacaine
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine 1
Other Intervention Name(s)
Early Dexmedetomidine
Intervention Description
Early intraperitoneal injection of dexmedetomidine and bupivacaine
Intervention Type
Drug
Intervention Name(s)
dexmedetomidine 2
Other Intervention Name(s)
Late Dexmedetomidine
Intervention Description
Late intraperitoneal injection of dexmedetomedine and bupivacaine
Primary Outcome Measure Information:
Title
The degree of pain
Description
measurement of VAS
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ASA II or III. Age 18 to 65 years. Elective surgeries Exclusion Criteria: Patients with severe hepatic (more than child c), renal (known CKD)and cardiac (known IHD) troubles. Patients with extensive intraperitoneal adhesions. Patients with a history of drug or analgesic abuse. Known drug allergy or indigestion. Intraoperative lavage of more than 500ml.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ehab H Gendy, MD
Organizational Affiliation
Assistant Professor of Anesthesia, intensive care and pain releif
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Cancer Institute
City
Cairo
ZIP/Postal Code
11796
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
After manuscript approval and acceptance by a journal
Citations:
PubMed Identifier
36281310
Citation
Shaker EH, Soliman MS, Hanafy A, Elsabeeny WY. Comparative Study Between Early versus Late Intraperitoneal Administration of Either Bupivacaine/Tramadol or Bupivacaine/Dexmedetomidine for Perioperative Analgesia in Abdominal Laparoscopic Cancer Surgeries: A Prospective Randomized Study. J Pain Res. 2022 Oct 18;15:3233-3243. doi: 10.2147/JPR.S376681. eCollection 2022.
Results Reference
derived
Links:
URL
https://www.saudija.org/article.asp?issn=1658-354X;year=2018;volume=12;issue=3;spage=399;epage=405;aulast=Elnabtity
Description
Intraperitoneal dexmedetomidine as an adjuvant to bupivacaine for postoperative pain

Learn more about this trial

Intraperitoneal Tramadol Versus Dexmedetomedine for Analgesia After Abdominal Laparoscopic Cancer Surgeries

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