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

• Sponsor: Yonsei University (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05984212
• Collaborator: (none)
• Enrollment: 56
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 11
• Patients Per Site Per Month: 5.1

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Single Port Laparoscopic Adnexal Surgery	Drug: Ultrasound guided rectus sheath block with dexmedetomidine; Drug: Ultrasound guided rectus sheath block with normal saline	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 56 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Double blind randomized controlled trialDouble blind randomized controlled trial
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Masking Description: Investigator prepared the drug and participant and outcomes assessor were blind to the group allocation
• Primary Purpose: Supportive Care
• Official Title: Effect of Preoperative Rectus Sheath Block on Quality of Recovery in Single Port Laparoscopic Adnexal Surgery: A Randomized Controlled Trial
• Anticipated Study Start Date: Aug 1, 2023
• Anticipated Primary Completion Date: Jul 1, 2024
• Anticipated Study Completion Date: Jul 1, 2024

Arms and Interventions

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)

Outcome Measures

Primary Outcome Measures

1. Quality of Recovery 40 scale score at postoperative 24 hour [24 hours after the end of surgery]

   Postoperative quality of recovery according to the block performance

Secondary Outcome Measures

1. Intraoperative remifentanil consumption,postoperative pain score [at 0, 1, 6, 12, and 24 hours postoperative]

   To evaluate the effect of rectus sheath block on intraoperative and postoperative pain and patients' satisfaction

2. rescue analgesics administered up to 24 hours postoperatively [intraoprative and postoperative 24hours]

   To evaluate the effect of rectus sheath block on intraoperative and postoperative pain and patients' satisfaction

3. satisfaction with pain control [intraoprative and postoperative 24hours]

   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.

4. serum cortisol level (μg/dL) before and after surgery [intraoprative and postoperative 24hours]

   To evaluate the effect of rectus sheath block on intraoperative and postoperative pain and patients' satisfaction

5. leukocyte level (10^3/μL) before and after surgery [intraoprative and postoperative 24hours]

   To evaluate the effect of rectus sheath block on intraoperative and postoperative pain and patients' satisfaction

6. arterial pH before and after surgery [intraoprative and postoperative 24hours]

   To evaluate the effect of rectus sheath block on intraoperative and postoperative pain and patients' satisfaction

7. blood glucose level (mg/dL) before and after surgery [intraoprative and postoperative 24hours]

   To evaluate the effect of rectus sheath block on intraoperative and postoperative pain and patients' satisfaction

8. measurement of adequate analgesia (NRS <4) before and after surgery [intraoprative and postoperative 24hours]

   To evaluate the effect of rectus sheath block on intraoperative and postoperative pain and patients' satisfaction

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

2. 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Severance hospital	Seoul		Korea, Republic of

Sponsors and Collaborators

• Yonsei University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Yonsei University
• ClinicalTrials.gov Identifier: NCT05984212
• Other Study ID Numbers: 4-2023-0611
• First Posted: Aug 9, 2023
• Last Update Posted: Aug 9, 2023
• Last Verified: Aug 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Dexmedetomidine

Study Results

No Results Posted as of Aug 9, 2023