Effect of Preoperative Rectus Sheath Block on Quality of Recovery in Single Port Laparoscopic Adnexal Surgery

Effect of Preoperative Rectus Sheath Block on Quality of Recovery in Single Port Laparoscopic Adnexal Surgery: A Randomized Controlled Trial

In this study, the investigators aimed to demonstrate if the quality of recovery in patients undergoing single-port laparoscopic adnexal surgery, with preoperative rectus sheath block and intraoperative opioid administration based on analgesia nociception index, improves compared to the patients without block.

Study Overview

• Status: Not yet recruiting
• Conditions: Single Port Laparoscopic Adnexal Surgery
• Intervention / Treatment: Drug: Ultrasound guided rectus sheath block with dexmedetomidine; Drug: Ultrasound guided rectus sheath block with normal saline

• Study Type: Interventional
• Enrollment (Estimated): 56
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Youngwon Kim; Phone Number: 82-10-4240-6849; Email: youngwon@yuhs.ac

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Severance Hospital
    • Contact: Youngwon Kim; Phone Number: 82-10-4240-6849; Email: youngwon@yuhs.ac

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Adult female patient aged 19 years or older undergoing elective single-port laparoscopic adnexal surgery under general anesthesia at Yonsei Cancer Center

1. patients with moderate to severe pain before surgery 2. patients with history of taking chronic analgesic use, 3. patients allergic or hypersensite to remifentanil or local anesthetic (ropivacaine), 4. patients with infection at the site of the block, 5. patietns who cannot communicate

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: dexmedetomidine infusion group	Drug: Ultrasound guided rectus sheath block with dexmedetomidine; Intervention Group: Ultrasound guided rectus sheath block with 0.5% ropivacaine 20ml at each side (bilateral)
Placebo Comparator: normal saline infusion group	Drug: Ultrasound guided rectus sheath block with normal saline; Control Group: Ultrasound guided rectus sheath block with 0.9% normal saline 20ml at each side (bilateral)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of Recovery 40 scale score at postoperative 24 hour	Postoperative quality of recovery according to the block performance	24 hours after the end of surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraoperative remifentanil consumption,postoperative pain score	To evaluate the effect of rectus sheath block on intraoperative and postoperative pain and patients' satisfaction	at 0, 1, 6, 12, and 24 hours postoperative
rescue analgesics administered up to 24 hours postoperatively	To evaluate the effect of rectus sheath block on intraoperative and postoperative pain and patients' satisfaction	intraoprative and postoperative 24hours
satisfaction with pain control	Patient self-rated overall satisfaction with pain control. Evaluated on an 11-point scale from 0 to 10, with 0 points for completely dissatisfied and 10 points for complete satisfaction. The higher the number, the more satisfactory it is.	intraoprative and postoperative 24hours
serum cortisol level (μg/dL) before and after surgery	To evaluate the effect of rectus sheath block on intraoperative and postoperative pain and patients' satisfaction	intraoprative and postoperative 24hours
leukocyte level (10^3/μL) before and after surgery	To evaluate the effect of rectus sheath block on intraoperative and postoperative pain and patients' satisfaction	intraoprative and postoperative 24hours
arterial pH before and after surgery	To evaluate the effect of rectus sheath block on intraoperative and postoperative pain and patients' satisfaction	intraoprative and postoperative 24hours
blood glucose level (mg/dL) before and after surgery	To evaluate the effect of rectus sheath block on intraoperative and postoperative pain and patients' satisfaction	intraoprative and postoperative 24hours
measurement of adequate analgesia (NRS <4) before and after surgery	To evaluate the effect of rectus sheath block on intraoperative and postoperative pain and patients' satisfaction	intraoprative and postoperative 24hours

Collaborators and Investigators

• Sponsor: Yonsei University
• Investigators: Principal Investigator: Youngwon Kim, Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2023
• Primary Completion (Estimated): July 1, 2024
• Study Completion (Estimated): July 1, 2024

Study Registration Dates

• First Submitted: July 16, 2023
• First Submitted That Met QC Criteria: August 1, 2023
• First Posted (Actual): August 9, 2023

Study Record Updates

• Last Update Posted (Actual): August 9, 2023
• Last Update Submitted That Met QC Criteria: August 1, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Hypnotics and Sedatives; Dexmedetomidine
• Other Study ID Numbers: 4-2023-0611

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No