IV Dexmedetomidine vs Oral Gabapentin and Their Combination for Postoperative Analgesia in Cancer Patients Undergoing Modified Radical Mastectomy

NCT06354478 | Completed DMC

• 1 other identifier: ms-103-2021
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

Breast cancer is the most common malignant tumour among females with an incidence of about 2.1 million women every year.Nearly about 40-60% of breast surgery patients develop severe acute postoperative pain.⁴ Opioids are the current best standard drugs for postoperative pain relief, however, exposure to large doses of opioids leads to multiple side effects like prolonged sedation, respiratory depression, nausea, and vomiting.We are comparing two different drugs and their combination for perioperative analgesia for MRM. This work is a comparative study that aims to compare the analgesic effects of perioperative IV infusion of dexmedetomidine, preoperative oral gabapentin, and their combination in patients undergoing modified radical mastectomy surgery regarding the time of first rescue analgesia, postoperative morphine consumption, and possible complications.

Conditions

Breast Cancer; Pain, Postoperative; Pain, Acute

Keywords

Breast Cancer; Perioperative pain; Dexmedetomidine; Gabapentin

Outcome Measures

Primary Outcomes (1)

• The time to first rescue analgesia during the first 24 hour Postoperatively.

  Time from postoperative recovery till the patients have pain enough requesting analgesia

  24 hrs

Secondary Outcomes (4)

• Total postoperative morphine consumption till the first 24 hours

  24 hrs

• The degree of postoperative sedation according to Ramsay scores

  2 hrs

• VAS scores both at rest and during shoulder movement

  24 hrs

• Postoperative nausea and vomiting (PONV) as side effects of morphine.

  24 hrs

Study Arms (3)

D group

EXPERIMENTAL

D group: Patients will receive two oral placebo capsules (starch capsules) 1 hour before surgery, and then will receive a loading dose of 1µg/kg of dexmedetomidine made to 50 ml using normal saline and given intravenously just before induction of anaesthesia over 10 minutes while patient vital signs monitored followed by intravenous infusion of dexmedetomidine diluted in normal saline with a dose of 0.5µg/kg/hour starts with induction of anaesthesia at a rate of 10 ml/hour through identical syringe pump until skin closure.

Drug: Dexmedetomidine Hydrochloride 0.5 MG/ML

G group

EXPERIMENTAL

G group: Patients will receive two oral gabapentin (300 mg) capsules for a total of 600 mg gabapentin (Neurontin; Pfizer, Cairo, Egypt) 1 hour before surgery, and then will receive 50 ml of normal saline given intravenously just before induction of anaesthesia over 10 minutes while patient vital signs monitored followed by intravenous normal saline infusion intraoperatively starts with induction of anaesthesia at a rate of 10 ml/hour through identical syringe pump until skin closure.

Drug: Gabapentin

DG group

EXPERIMENTAL

DG group: Patients will receive two gabapentin (300 mg) capsules for a total of 600 mg gabapentin 1 hour before surgery, and then will receive a loading dose of 1µg/kg of dexmedetomidine made to 50 ml using normal saline and given intravenously just before induction of anaesthesia over 10 minutes while patient vital signs monitored followed by intravenous infusion of dexmedetomidine diluted in normal saline with a dose of 0.5µg/kg/hour starts with induction of anaesthesia at a rate of 10 ml/hour through identical syringe pump until skin closure.

Drug: Dexmedetomidine Hydrochloride 0.5 MG/ML; Drug: Gabapentin

Interventions

Dexmedetomidine Hydrochloride 0.5 MG/ML DRUG

Will be used either alone or in combination of gabapentin

D group; DG group

Gabapentin DRUG

Will be used either alone or in combination of Dexmedetomidine

DG group; G group

Eligibility Criteria

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

You may qualify if:

• ● Female physical status ASA I, II.
• Body mass index (BMI): 20 kg/m2- 40 kg/m2.
• A patient undergoing modified radical mastectomy under general anaesthesia.

You may not qualify if:

• ● Patient refusal.
• Known sensitivity or contraindication to study drugs (e.g.: dexmedetomidine, gabapentin, or morphine ).
• History of psychological disorders, chronic pain, and/or sympathetic disorders.
• Patients receiving medications that are considered to result in tolerance to opioids as those who are receiving medications for cancer pain (e.g. tramadol and hydromorphone).
• Significant liver insufficiency (liver enzymes more than two folds or severe liver cirrhosis) or renal insufficiency (plasma creatinine more than 1.5 mg/dl).
• Severe respiratory disorders (e.g. Chronic obstructive pulmonary disease, Bronchial asthma), or cardiac disorders (e.g. ischemic heart disease, regional motion wall abnormality, EF\< 50%).
• Pregnancy.

Sponsors & Collaborators

• National Cancer Institute, Egypt: lead

Study Sites (1)

National Cancer Institute

Cairo, Egypt

Location

MeSH Terms

Conditions

Breast Neoplasms; Pain, Postoperative; Acute Pain

Interventions

Dexmedetomidine; Gabapentin

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Amines; Organic Chemicals; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Ashgan Raouf Ali, Professor

  Anaesthesiology Faculty of Medicine - Cairo University

  STUDY CHAIR

• Heba Ismail Ahmed Nagy, Professor

  Anaesthesiology Faculty of Medicine - Cairo University

  STUDY DIRECTOR

• Mina Samir Said Khalil

  Anaesthesiology National Cancer Institute - Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Both patients and Investigator for postoperative pain will be blinded: * Group 1(D): (n=30) Patients will receive oral placebo starch capsules 1 hour preoperatively and intraoperative intravenous infusion of dexmedetomidine with general anaesthesia. * Group 2(G): (n=30) Patients will receive oral gabapentin capsules for 1 hour preoperatively and intraoperative intravenous saline infusion with general anaesthesia. * Group 3(DG): (n=30) Patients will receive oral gabapentin capsules for 1 hour preoperatively and intraoperative intravenous infusion of dexmedetomidine with general anaesthesia.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2024
• First Posted: April 9, 2024
• Study Start: January 1, 2021
• Primary Completion: February 1, 2022
• Study Completion: July 1, 2022
• Last Updated: April 9, 2024

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)