The Quality of Recovery After Intrathecal Morphine or Adductor Canal Block in Anterior Cruciate Ligament Reconstruction

Phase 4

Recruiting

• Conditions: Arthroscopic Anterior Cruciate Ligament Reconstruction; Quality of Recovery; Intrathecal Morphine; Adductor Canal Block
• Interventions: Drug: Adductor canal block; Drug: Intrathecal morphine

• Registration Number: NCT05742958
• Lead Sponsor: Cukurova University

Brief Summary

The Quality of Recovery 40 (QoR-40) is a multidimensional questionnaire that addresses many aspects of postoperative recovery. The QoR-40 has been used many times to measure the recovery of patients after different surgeries, and this questionnaire seems to be a reliable tool for evaluating anesthesia-related techniques, including regional anesthesia. Arthroscopic knee surgery causes moderate to severe postoperative pain for most patients. Various methods such as different systemic drugs, peripheral or central blocks and intra-articular injections have been developed for the effective, safe and long-term control of this pain. In recent years, it has been shown that regional anesthesia techniques reduce the need for opioids in orthopedic ambulatory surgeries and accelerate recovery and discharge. However, there is no consensus on which is the best approach among these various regional techniques. However, adductor canal block (ACB) and intrathecal morphine (ITM) are the preferred regional methods in the perioperative pain management of knee surgery. In this study, it was aimed to test the effectiveness of intrathecal morphine or adductor canal block added to spinal anesthesia on the quality of recovery in patients undergoing arthroscopic anterior cruciate ligament reconstruction surgery.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-02-05
• Study First Submitted QC: 2023-02-14
• Study First Posted: 2023-02-24
• Study Start: 2023-06-07
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-11
• Last Update Posted: 2023-09-13
• Primary Completion: 2023-09-15
• Study Completion: 2023-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• American Society of Anesthesiologists (ASA) physical status I or II adult patients aged 18-65 years undergoing elective arthroscopic anterior cruciate ligament reconstruction will be included in the study.

Exclusion Criteria

• We will exclude patients with known coagulopathy, allergies to the studied drugs, obesity (BMI >35kg/m2), renal and/or hepatic insufficiency, chronic pain syndrome, mental impairment, depression, chronic alcoholism, and usage of antidepressant and analgesic drugs before surgery.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Adductor canal block (Group ACB)	Adductor canal block	Spinal anesthesia from L4-L5 interval with 12.5-15 mg hyperbaric 0.5% bupivacaine + adductor canal block (30 mL 0.25% bupivacaine) will be applied.
Intrathecal morphine (Group ITM)	Intrathecal morphine	12.5-15 mg hyperbaric 0.5% bupivacaine + 0.1 mg (0.1 mL) morphine with a single dose intrathecal injection through the L4-L5 interval (spinal anesthesia) + placebo adductor canal block (with 30 mL saline) will be administered.

Primary Outcome Measures

Name	Time	Method
24-hour Quality of Recovery-40 (QoR-40) questionnaire scores	Postoperative 24-hour.	The score ranges from 40 to 200. A higher score on the QoR-40 means better recovery following arthroscopic anterior cruciate ligament reconstruction.

Secondary Outcome Measures

Name	Time	Method
Treatment satisfaction	Postoperative 24-hour	Treatment satisfaction will be assessed at 24 h using a 3-point rating scale ranging from 1 to 3: 1 = excellent satisfaction (Numeric Rating Score/NRS=0), 2 = good satisfaction (NRS=1-2), 3 = dissatisfaction (NRS=3-4)
Discharge time	Duration of postoperative 24-hour	Length of hospital stay
The time to first postoperative mobilisation	Duration of postoperative 24-hour	Ambulation time
Numeric Rating Score (NRS)	Postoperative 1, 2, 4, 8, 12 and 24-hour.	Numeric rating score for postoperative pain intensity. Pain intensity will be evaluated using a numeric rating scale with descriptive terms at intervals along a horizontal line of 10 cm length: 0 mm = no pain, 10 cm = worst pain imaginable.
Supplement analgesia requirement	Postoperative 1, 2, 4, 8, 12 and 24-hour.	Amount of additional analgesics taken outside of the usual treatment protocol.

Trial Locations

Locations (1)

Cukurova University; 🇹🇷 Adana, Saricam, Turkey