Role of Dexamethasone for Erector Spinae Plane Block in Patients Undergoing Total Abdominal Hysterectomy

Postoperative Pain Clinical Trial

Official title:

Role of Adjuvant Dexamethasone for Erector Spinae Plane Block for Postoperative Analgesia in Patients Undergoing Total Abdominal Hysterectomy: A Randomized, Double-blind Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03769818
• Other study ID #: aswu/181/18
• Status: Completed
• Phase: N/A
• Start date: January 1, 2019
• Est. completion date: August 1, 2020

Study information

• Verified date: August 2020
• Source: Aswan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim to study the efficacy of bupivacaine 0.25% with dexamethasone and that of bupivacaine 0.25% alone for erector spinae plane block for postoperative analgesia in patients undergoing total abdominal hysterectomy Group 1: bupivacaine 0.25% + dexamethasone 8 mg

• Group 2: bupivacaine 0.25%

• Group3: control group A prospective Randomized Interventional double-blind study.

Description:

Optimal dynamic analgesia is recognized as the key to enhanced recovery following open abdominal surgery. In the last decade, there has been a significant shift away from thoracic epidural analgesia (TEA) that has been long considered as the gold standard. Various techniques have tried to replicate the analgesic efficacy of TEA. They include transversus abdominis plane analgesia (TAP), rectus sheath analgesia (RS), wound infusion analgesia (WI) and trans muscular quadratus lumborum analgesia. However, each of these techniques has specific limitations that prevent them from being the analgesic technique of choice for all open abdominal surgeries. Chin et al first described the erector spinae plane (ESP) block for providing analgesia following ventral hernia repair. The unique feature of the ultrasound-guided truncal blocks is that in all of these techniques, in contrast to peripheral nerve blocks, no nerve or plexus needs to be identified: Local anesthesia (LA) is injected in a particular muscle plane, in which the injectate spreads and reaches the intended nerves. This simple mechanism has made delivery of nerve blocks easy and versatile.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: August 1, 2020
• Est. primary completion date: March 30, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 30 Years to 60 Years

Eligibility

Inclusion Criteria:

• Women ranging age between 30-60 years a who undergoing elective total abdominal hysterectomy

Exclusion Criteria:

• Participants had known sensitivity to bupivacaine

• Participants had difficulty in intubation

• Participants were on chronic pain medication or already on long-term opioids

• Participants smokers

• Participants with disabilities who were unable to communicate pain levels

• refuse to consent

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Drug:
• bupivacaine
Bilateral TAP block with 20 ml of 0.25% bupivacaine
• dexamethasone
Bilateral TAP block with 4 mg/kg dexamethasone diluted with isotonic saline.
• placebo to dexamethasone
Bilateral TAP block with placebo to dexamethasone.
• placebo to bupivacaine
Bilateral TAP block with placebo to bupivacaine.

Locations

Country	Name	City	State
Egypt	Aswan University	Aswan

Sponsors (1)

Lead Sponsor	Collaborator
Aswan University Hospital

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual analog score for pain during movement	movement-evoked pain measurements ranging from 0 to 10, where 0 no pain and 10 maximum pain	24 hours post operative
Secondary	Visual analog score for pain during rest	ranging from 0 to 10, where 0 no pain and 10 maximum pain	24 hours postoperative
Secondary	number of patients need Fentanyl consumption	calculation of the number of patients need Fentanyl consumption	24 hours postoperative
Secondary	number of days patients stay in hospital	calculation of number of days patients stay in hospital	4 weeks