Intraperitoneal Tramadol Versus Dexmedetomedine for Analgesia After Abdominal Laparoscopic Cancer Surgeries
Condition: Analgesia
MeSH terms: Agnosia
Study type: Interventional
Phase: Phase 2/Phase 3

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.
    

Intervention name(s): Tramal 1; Tramal 2; Dexmedetomidine 1; dexmedetomidine 2
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Early intraperitoneal injection of tramal and bupivacaine; Late intraperitoneal injection of tramal and bupivacaine; Early intraperitoneal injection of dexmedetomidine and bupivacaine; Late intraperitoneal injection of dexmedetomedine and bupivacaine
Other intervention name(s): Early tramal; Late tramal; Early Dexmedetomidine; Late Dexmedetomidine
Intervention MeSH terms: Dexmedetomidine; Tramadol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment