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NCT Number: NCT02566096

Efficacy of Transverses Abdominis -Plane Block With Bupivacaine Versus Bupivacaine With Morphine Postoperatively

This study aims to compare the analgesic efficacy of transversus abdominis-plane block with bupivicaine versus bupivacaine with morphine in patients undergoing major abdominal cancer surgery.

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Key information

Conditions

Abdominal Cancer

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

South Egypt Cancer Instuite

Asyut, 171516, Egypt

About this study

This randomized study will be approved by the local ethics committee of South Egypt Cancer Institute, Assuit University, Egypt after written informed consent. This study will include approximately 60 ASA I-II cancer patients with age range (18-60) years, weight (50- 85) kg who will be scheduled for lower abdominal cancer surgery (abdominal hysterectomy, oophorectomy and radical cystectomy). Exclude from the study Patients with known drug allergy to study drugs, significant cardiac, respiratory, renal or hepatic disease, coagulation disorders and those with psychiatric illnesses that would interfere with perception and assessment of pain. Preoperatively, patients will be taught how to evaluate their own pain intensity using the Visual Analog Scale (VAS), scored from 0-10 (where 0= no pain and 10=worst pain imaginable).

Patients will be randomly assigned using an online research randomizer into two groups, 30 patients in each group:

Group 1:

30 patients receive ultrasound guided transversus abdominis-plane block with local anesthetic 20 ml of bupivacaine 0.5 % diluted in 20 ml saline (total volume 40 ml) in two divided doses i.e. 20 ml is administered on each side of the abdominal wall.

Group 2:

30 patients receive ultrasound guided transversus abdominis-plane block with local anesthetic 20 ml of bupivacaine 0.5% + 10 mg morphine diluted in 20 ml saline (total volume 40 ml) in two divided doses i.e. 20 ml is administered on each side of the abdominal wall.

Surgery will be performed under standard general anesthesia and ultrasound guided TAP block will be performed before induction of GA.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 60 ASA I-II cancer patients with age range (18-60) years,
  • weight (50- 85) kg

Exclusion criteria

  • with patients with known drug allergy to study drugs
  • with significant cardiac, respiratory, renal or hepatic disease
  • with coagulation disorders
  • those with psychiatric illnesses that would interfere with perception and assessment of pain.

Treatment and study plan

transversus abdominis-plane block with local anesthetic 20 ml of bupivacaine 0.5% + 10 mg morphine

Drug

compare the analgesic efficacy of transversus abdominis-plane block with bupivicaine with morphine in patients undergoing major abdominal cancer surgery.

Primary outcomes

  1. The presence and severity of pain at rest and on coughing will be assessed using a Visual Analog Scale

    Time frame: first 24 hours postoperatively

    The presence and severity of pain at rest and on coughing will be assessed using a Visual Analog Scale will be assessed postoperatively at baseline, 2, 4, 6, 8, 12, 18, and 24 hours.

Secondary outcomes

  1. the level of sedation by using sedation score

    Time frame: 24 hours postoperatively

    the level of sedation by using sedation score (awake and alert = 0, quietly awake = 1, asleep but easily roused= 2, deep sleep = 3) will be assessed postoperatively at baseline, 2, 4, 6, 8, 12, 18, and 24 hours.

  2. first request for analgesia in minutes will be observed

    Time frame: firsr 24 hours

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Efficacy of Transverses Abdominis -Plane Block With Bupivacaine Versus Bupivacaine With Morphine in Patients Undergoing Major Abdominal Cancer Surgery

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Oct 2, 2015
Registry last updated
Jul 15, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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