Intraperitoneal Tramadol Versus Dexmedetomedine for Analgesia After Abdominal Laparoscopic Cancer Surgeries

NCT04813016 | Completed Phase 2

• 1 other identifier: intraperitoneal analgesia
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Analgesia

Outcome Measures

Primary Outcomes (1)

• The degree of pain

  measurement of VAS

  24 hours

Study Arms (4)

Early tramal/bupivacaine

ACTIVE COMPARATOR

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.

Drug: Tramal 2; Drug: Dexmedetomidine 1; Drug: dexmedetomidine 2

Late tramal/bupivacaine

ACTIVE COMPARATOR

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.

Drug: Tramal 1; Drug: Dexmedetomidine 1; Drug: dexmedetomidine 2

Early dexmedetomedine/bupivacaine

ACTIVE COMPARATOR

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.

Drug: Tramal 1; Drug: Tramal 2; Drug: dexmedetomidine 2

Late dexmedetomedine/bupivacaine

ACTIVE COMPARATOR

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.

Drug: Tramal 1; Drug: Tramal 2; Drug: Dexmedetomidine 1

Interventions

Tramal 1 DRUG

Early intraperitoneal injection of tramal and bupivacaine

Also known as: Early tramal

Early dexmedetomedine/bupivacaine; Late dexmedetomedine/bupivacaine; Late tramal/bupivacaine

Tramal 2 DRUG

Late intraperitoneal injection of tramal and bupivacaine

Also known as: Late tramal

Early dexmedetomedine/bupivacaine; Early tramal/bupivacaine; Late dexmedetomedine/bupivacaine

Dexmedetomidine 1 DRUG

Early intraperitoneal injection of dexmedetomidine and bupivacaine

Also known as: Early Dexmedetomidine

Early tramal/bupivacaine; Late dexmedetomedine/bupivacaine; Late tramal/bupivacaine

dexmedetomidine 2 DRUG

Late intraperitoneal injection of dexmedetomedine and bupivacaine

Also known as: Late Dexmedetomidine

Early dexmedetomedine/bupivacaine; Early tramal/bupivacaine; Late tramal/bupivacaine

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Cancer Institute, Egypt: lead

Study Sites (1)

National Cancer Institute

Cairo, 11796, Egypt

Location

Related Publications (1)

• 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.

  PMID: 36281310 DERIVED

Related Links

• Intraperitoneal dexmedetomidine as an adjuvant to bupivacaine for postoperative pain

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ehab H Gendy, MD

  Assistant Professor of Anesthesia, intensive care and pain releif

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor of Anesthesia, intensive care and pain releif

Study Record Dates

• First Submitted: March 20, 2021
• First Posted: March 24, 2021
• Study Start: March 1, 2021
• Primary Completion: April 30, 2022
• Study Completion: May 1, 2022
• Last Updated: June 2, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)