Comparison Between Two Different Doses of Nulbuphine _bupivacaine in TAP Block in Cancer Abdominal Surgeries

NCT05090579 | Unknown

• 1 other identifier: Q123
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

To compare the analgesic effect of two different doses of nulbuphine (10 mg and 20 mg) added to bupivacaine in bilateral subcostal single injection in ultrasound-guided TAP block for abdominal surgeries.

Conditions

Pain, Postoperative

Outcome Measures

Primary Outcomes (1)

• time of request of first analgesia

  VAS (Visual Analogue Scale, 0-100 mm; where 0 = no pain, and 100 = worst imaginable pain) will be assessed, at rest, per hour for 24 hours post operatively. Moreover, VAS will also be assessed at 12 and 24 hours post-operatively while abducting the ipsilateral arm. If the patient experiences a pain of \> 3, IV morphine will be given at a dose of 2.5-5 mg per dose, with a maximum dose of 10 mg, aiming for a pain score of ≤ 3. Time which will pass until the request of first analgesia shall be determined for each group and compared.

  Time Frame: 24 hours post-operatively ]

Secondary Outcomes (1)

• total morphine consumption in the first 24 hours postoperatively

  Time Frame: 24 hours post-operatively ]

Study Arms (3)

Group I (BN10)

ACTIVE COMPARATOR

patients will receive an ultrasound-guided TAP block with 20 mL of 0.25% bupivacaine , 1 mL of 10 mg of nulbuphine plus 4 mL of normal saline to reach 25 mL as total volume on each side of the abdominal wall.

Procedure: Group I (BN10)

Group II (BN20)

ACTIVE COMPARATOR

patients will receive an ultrasound-guided TAP block with 20 mL of 0.25% bupivacaine ,2 mL of 20 mg of nulbuphine plus 3 mL of normal saline to reach 25 mL as total volume on each side of the abdominal wall.

Procedure: Active Comparator:Group ll (BN20)

Group lll(B)

ACTIVE COMPARATOR

patients will receive 20 mL of 0.25%bupivacaine plus 5 mL of normal saline to reach 25 mL as total volume on each side of the abdominal wall.

Procedure: Active Comparator:Group lll (B)

Interventions

Group I (BN10) PROCEDURE

patients will receive an ultrasound-guided TAP block with 20 mL of 0.25% bupivacaine, 1 mL of 10 mg of nalbuphine plus 4 mL of normal saline to reach 25 mL as total volume on each side of the abdominal wall

Group I (BN10)

Active Comparator:Group ll (BN20) PROCEDURE

patients will receive an ultrasound-guided TAP block with 20 mL of 0.25% bupivacaine, 2 mL of 20 mg of nalbuphine plus 3 mL of normal saline to reach 25 mL as total volume on each side of the abdominal wall

Group II (BN20)

Active Comparator:Group lll (B) PROCEDURE

patients will receive 20 mL of 0.25%bupivacaine plus 5 mL of normal saline to reach 25 mL as total volume on each side of the abdominal wall

Group lll(B)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA classification I-ll,
• Aged \>18 years,
• weight 50-85 kg,
• Patients who will undergo abdominal cancer surgery.

You may not qualify if:

• Patient's refusal,
• patients with a history of allergies to studied drugs,
• Patients with coagulation disorders,
• Patients with opioid dependence,
• Patients with morbid obesity (body mass index more than 40 kg/m2),
• Patients with sepsis,
• patients with psychiatric illnesses that will interfere with the perception and assessment of pain .

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Amira Muhammed Othman

Asyut, Egypt

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Rania M. Abdel -Emam

  South Egypt cancer Institute, Assuit university hospitals

  STUDY DIRECTOR

• Shreen M. Muhammed, A.professor

  South Egypt cancer Institute, Assuit university hospitals

  STUDY DIRECTOR

• Eman A. Ismail

  Assiut University hospitals

  STUDY CHAIR

Central Study Contacts

Amira M Othman, MD

CONTACT

01098784161; Amiramothman8@gmail.com

Eman A Ismail, Professor

CONTACT

01060223755; Emanismail97@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident

Study Record Dates

• First Submitted: September 2, 2021
• First Posted: October 25, 2021
• Study Start: June 1, 2022
• Primary Completion: October 1, 2024
• Study Completion: October 1, 2024
• Last Updated: October 25, 2021

Record last verified: 2021-10

Locations

EG (1)